St Jude Medical Jobshttp://jobs.sjm.com2012-05-24 03:18:08.470599USAPlymouthAnalyst, IT Business Job Requisition #: 13365 Date Posted: 05/22/2012 Category: Information Technology Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary: Provides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments. Essential Functions: Provides application development support and coordination primarily to the Manufacturing and Distribution organizations by: • Facilitating meetings in the business area to review business processes and identify information system requirements and/or needs. • Making appropriate recommendations for continuing, modifying, or abandoning proposed projects and/or systems based on the results of feasibility studies and/or cost/benefit analyses. • Maintaining and documenting the logical and physical data models including data flow diagrams. • Developing business process flows and data models required by the department methodology for new system development or for process redesign. • Preparing project and system documentation consistent with standards and procedures outlined in the development methodologies. Provides project management support as a leader or member of a project team: • Develops project plans, work breakdown structures and task dependencies, communication plans, etc., according to the development methodologies. • Manages project activities and motivates members of the project team. • Provides updates and thorough communication to the project team, information systems and the impacted business areas. • Coordinates the implementation of information systems with IS personnel and members of the impacted business areas. Provides coaching and training support: • Maintains proficiency in the tool sets used within the supported business areas. • Supports the business areas in their tool sets, including training and developing subject matter experts within the supported business areas. • Conducts training that quickly prepares participants to use a maximum of system features. Maintains relationships and communications with business and IS units: • Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals. • Understands the various business entities, their information systems developed by IS, and the applications that they developed on their own. • Serves as a liaison between IS and the supported business areas. • Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems. • Provides effective written and verbal communications. Qualifications: • This person must have excellent communication and customer service skills and strong leadership and team motivation skills in order to manage work that requires effective delivery to internal SJM customers. • This includes bridging communication between technical areas and business areas for a full and complete understanding of expectations. • Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience. • Bachelor’s degree in Business, Computer Science or related field is preferred. • MBA a plus. |E-mail this position Submit Resume or C.V.2012-05-22 19:30:31United StatesSt. Jude MedicalMinnesota13365MNPlymouth, MN28867994http://jobs.sjm.com/xml/28867994/jobUSADallasSr. Automated Test Engineer Job Requisition #: NMD3210 Date Posted: 05/22/2012 Category: Electrical Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Senior Automated Test Engineer designs, develops, verifies, validates, and provides technical support for automated test systems used in the production of electronic medical devices for St. Jude Medical’s Neuromodulation Division (SJM-NMD).. This person is responsible for coordinating and managing all activities and deliverables associated with demonstrating production test systems are fit for their intended uses and produce reliable and repeatable test results in accordance with FDA Regulations and internal St. Jude development guidelines. In addition, this person shall provide strong, real-time technical analysis and troubleshooting support for both test system and product performance during day-to-day operations. Key areas of focus include: providing Design For Test (DFT) inputs to Product Development, translating and tracing product requirements into test specifications and user requirements, facilitating Failure Modes and Effects Criticality Analyses (FMECAs), constructing Master Validation Plans (MVPs), creating and executing Test Method Validations (TMVs), creating and executing Process Validations (including Installation, Operational, and Performance Qualifications), monitoring and trending product and test system performance, designing and implementing Process Controls, providing technical troubleshooting and preventive maintenance support for Operations, and developing procedures and detailed work instructions for operators and technicians who use the test systems, Major On-Going Responsibilities: • Interface with Product Development teams to generate test plans, test requirements, test specifications, and other relevant documents required to design, develop, verify, and validate automated production test systems • Attend internal customer reviews for improvement of automated test hardware and software to increase testing yield and throughput • Develop system architecture and relevant documentation, including hardware and software design and integration • Collaborate with Manufacturing Engineering, Quality Engineering, and production personnel to generate and implement test system improvements based on monitoring and trending both product and equipment performance • Participate in the design, development, and documentation of test cases for new or existing products • Provide production support for the automated testing of SJM-NMD products including (but not limited to): troubleshooting electronic and electro-mechanical failures, assembly and test process improvements, replacement of obsolete components, and identification / correction of design weaknesses • Participate in the review of new product designs for manufacturability including (but not limited to) circuit designs, PCB layouts and panel formats, and design for ease of assembly and test • Supervise engineering technicians and mentor entry-level engineers • Develop and implement manufacturing process flow documentation • Provide technical support for internal and external Quality and Procurement activities • Generate Engineering Change Notifications (ECNs) for the implementation of new design documentation or revision of existing design documentation, as required for products in production • Write protocols, execute Verification, Validation, and Characterization testing, and write reports Experience & Training: • Bachelors degree in Electrical Engineering or equivalent • Five or more years experience in developing test systems/solutions for production testing at the board, subassembly, and finished assembly levels • Hardware Integration Qualifications: at least 2 years of experience specifying and integrating data acquisition and control hardware such as PC-based DAQ boards, rack-based instruments (GPIB, VXI, PXI), motion control, and machine vision • Software Development Qualifications: at least 2 years of experience developing or interpreting and interfacing with professional-quality LabVIEW software applications using advanced architecture and data structure techniques (experience with TestStand, C/CVI/C++, and databases is preferred) • A broad knowledge of measurement and control principles is required • Medical device experience preferred – Knowledge of FDA Quality System Regulations 21 CFR Part 820 and ISO 9001 / 13485 • Strong analytical, problem solving, and troubleshooting skills • Sound electrical design practices, including (but not limited to): grounding techniques, cabling, and board layout (familiarity with OrCAD preferred) • Mastery of assembly drawings, schematics, flow charts, spreadsheets and ECN procedures • Clear, constructive, and effective communication with co-workers, management, external suppliers and customers to meet project goals • Proven problem solving and critical reasoning skills Other Skills/Characteristics: • Ability to work under pressure and with short deadlines • Ability to multi-task and juggle priorities without loosing focus and delivering on the objectives at hand • Ability to work independently, with good organizational skills and attention to detail • Develop and manage project requirements |E-mail this position Submit Resume or C.V.2012-05-22 19:30:13United StatesSt. Jude MedicalTexasNMD3210TXDallas, TX28867987http://jobs.sjm.com/xml/28867987/jobUSADallasProduct Manager Job Requisition #: NMD3209 Date Posted: 05/22/2012 Category: Marketing Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Major Ongoing Responsibilities: • Assist in the development of the strategic vision for next-generation neurostimulation products. • Define the requirements and business cases for new products and enhancements. • Direct market research to assess customer needs, to verify product requirements, and to evaluate design prototypes. • Work with cross-functional product development team to bring products to market. • Manage product development activities assigned to Marketing. Tasks include preparing customer requirements documents, creating product labeling (including manuals), defining and conducting user-validation activities, generating product forecasts, and setting product pricing. • Assist Regulatory and Clinical departments with submissions and clinical studies. • Develop in-depth knowledge of the sales process and provide critical sales tools. • Plan and execute the launch of new products. Tasks include developing product positioning, writing content for marketing pieces, and assisting product support areas with product training. • Use market knowledge and product expertise to support Customer Service, Sales, Clinical, Regulatory Affairs, and Engineering. • Monitor and evaluate competitive activity and intellectual property for opportunities and threats. • Participate in domestic and international physician training and sales training activities. • Provide sales support by attending key physician congresses and meetings, conducting field visits, and providing technology presentations to small (2-10 customers) and large (100+ customers) groups of physicians. • Provide direction for on-going product forecast management. • Assist with the manage worldwide product obsolesce plans. Experience and Training: • Bachelors degree in marketing, engineering or other related field; MBA preferred • Minimum 2 years’ experience in a medical device related industry (implantable device company preferred) in a product management or marketing position with product launch experience. Field sales experience a plus. • Familiarity with healthcare/medical regulatory, quality, and reimbursement environment • Track-record of effectively collecting, analyzing, prioritizing, and communicating customer needs for new products • Track-record of effectively leading cross-functional teams Other Skills/Characteristics: • Exceptional interpersonal and leadership skills • Excellent written and verbal communication skills • Ability to communicate effectively with physicians, nurses, and sales representatives • Comfortable presenting in front of large groups of people • Excellent analytical skills • Results-oriented, resourceful team player able to foster cooperation within a working group or team • Ability to work effectively on a multitude of projects in a fast-paced environment • Ability to lead and influence cross-functional teams • Ability to effectively make decisions with imperfect information |E-mail this position Submit Resume or C.V.2012-05-22 19:30:12United StatesSt. Jude MedicalTexasNMD3209TXDallas, TX28867986http://jobs.sjm.com/xml/28867986/jobUSAPlymouthClinical Programs Manager Job Requisition #: 13203 Date Posted: 05/22/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Job Overview The Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions. Responsibilities: • Manage the successful and timely execution of all device clinical trials • Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations • Responsible for the training, initiation and management of clinical trial sites • Establish and manage trial budgets including enrollment targets • Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending • Participate in the design and development of new trials • Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis • Develop and maintain individual training programs for all staff • Able to assist in the drafting and development of publications based on the results of the clinical trials • Develop and maintain strong relationships with principal investigators at clinical trial sites • Ensure that St. Jude Medical is using the most current tools in the management of clinical trials • Travel estimated at 30% Requirements: • BA/BS in life sciences or nursing • 10+ years experience in clinical research • 5+ years experience successfully managing a team of clinical research professionals • 3-5 years clinical research experience in medical device PREFERABLY • Demonstrated knowledge of and experience with GCP and all US regulations • Hands on experience in IDE clinical trials and the preparation of PMAs • Comfortable in both the clinical and business setting • Comfortable presenting to senior management • Ability to work independently and take direction from others • Strong work ethic • Excellent communication, problem-solving and organizational skills • Computer proficiency including Microsoft Office applications Preferred Qualifications: • Advanced degree in life sciences or nursing a strong plus • Knowledge and experience with European and Japan device clinical trials a strong plus • Experience in the cardiovascular therapeutic areas |E-mail this position Submit Resume or C.V.2012-05-22 19:30:08United StatesSt. Jude MedicalMinnesota13203MNPlymouth, MN28867984http://jobs.sjm.com/xml/28867984/jobUSASt. PaulSystems Administrator - Wintel Job Requisition #: Corp 12041 Date Posted: 05/22/2012 Category: Information Technology Administrative Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview The System Administrator position identifies requirements, builds, tests, deploys and maintains scalable and stable technical operating environment as part of overall enterprise IT technology management function. They will also partner with customers, vendors and other dependent IT domains to ensure successful delivery of business applications and scalable operations. Job Duties: • Collects and documents technical requirements used for design specifications • Assists in evaluating new requirements and recommends new processes and standards as appropriate • Designs, builds, tests and administers software and technical platforms to standards • Effectively identifies user and technical dependencies, identifies risk, and engages other technical domains to define broader solution sets • Define Build Standards and Test Standards, guidelines, best practices, and produce metrics as directed • Establish and maintain system specific documentation and operational procedures within the domain • Conducts proactive capacity planning, performance monitoring, configuration tuning and technology refresh • Perform incident and problem analysis and resolve escalated technical problems following established guidelines • Manage & reinforce systems security in accordance with industry best practices and enterprise policy • Participates in all call rotation as directed • Performs other duties as assigned Qualifications: • Bachelor’s Degree in Computer Science, MIS, and Mathematics, Engineering, Business or area of functional responsibility preferred, or equivalent 6 years of industry work experience • 3+ years of industry experience in a technical profession • Experience working in a broader enterprise/cross division business unit model, preferred • Ability to work in a highly matrix and geographically diverse business model • Ability to work effectively within a team and as an individual contributor in a fast paced changing environment -- multi-tasks, prioritized and meets deadlines in timely manner • Ability to effectively work in a fast paced changing environment • Ability to travel between multiple sites within the Twin Cities (up to 20% of time) • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization • Strong organizational, attention to detail and task follow-up skills • Adept at handling multiple assignments in a timely manner and meeting assigned deadlines Technical Qualifications: Wintel: • 3+ years of technical experience with Windows based server operating systems administration in a medium to large completer server environment • 3+ years of VmWare ESX experience • Working knowledge of Citrix related technologies • Microsoft Certified System Administrator (MCSA) certification or equivalent experience • 2 years of experience installing, configuring and managing x86 based server hardware and virtual machines • Good working knowledge of Active Directory • Basic knowledge of TCPIP and DNS required • Knowledge of basic Windows concepts such as patching and installation • Experience with Windows clusters • Demonstrated understanding of networking/distributed computing environment concepts; knowledge of and experience with principles of routing, client/server programming • Knowledge of IT Infrastructure Library principles and best practices • Good consultative and communication skills • Ability to work effectively within a team and as an individual contributor • Ability to manage multiple work streams and priorities • Ability to effectively work in a fast paced changing environment |E-mail this position Submit Resume or C.V.2012-05-22 19:29:17United StatesSt. Jude MedicalMinnesotaCorp 12041MNSt. Paul, MN28867951http://jobs.sjm.com/xml/28867951/jobUSAIrvineQuality Engineer Job Requisition #: AF13886 Date Posted: 05/21/2012 Category: Engineering Quality Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, hands-on experienced Quality Assurance Engineer. This position provides quality support to our EnSite product line and works closely with manufacturing. This Engineer will monitor quality on the production floor working with inspectors. This Engineer will work closely with production engineers during product development activities to ensure quality checkpoints are in place as part of the production process. Impact this role will have: • Performs process and product qualification as outlined in a validation protocol to ensure finished products meet standards. • Works closely with production engineers to ensure quality checkpoints are in place as part of the production process and that processes are clear and concise. • Assists in the implementation of changes required as a result of internal audit findings. • Assists with IQ/OQ during development stage in preparation for process implementation. • Participates on new product development cross-functional teams. • Performs material processing. • Performs statistical analysis reports on a monthly basis. Required Qualifications: • Bachelor’s degree in Electrical Engineering • 3+ years of experience in a quality assurance role within a manufacturing environment • Experience with different types of testing including analytical testing, performance testing, design verification testing, material testing, and chemistry • Knowledge of standards • Experience with materials testing, analytical testing, performance testing, biocompatibility testing, design verification testing • Experience supporting a manufacturing environment • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Soldering certification • Medical device experience |E-mail this position Submit Resume or C.V.2012-05-21 20:25:06United StatesSt. Jude MedicalCaliforniaAF13886CAIrvine, CA28837110http://jobs.sjm.com/xml/28837110/jobUSAIrvineSystems Engineer I Job Requisition #: AF13885 Date Posted: 05/21/2012 Category: Systems Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber APD Systems Engineer I. The Advanced Process Development-Systems (APDS) group develops processes and test systems to manufacture new electronic systems for the Atrial Fibrillation Division. The group also provides ongoing product engineering support for key quality improvements and cycle time reductions. As an Engineer I, the individual will execute activities on key new product development programs and product support initiatives. Impact this role will have within the AF division: Uses engineering knowledge to participate in the development of innovative medical devices or components/subsystems in support of company’s strategic plan. Conducts process development work as part of a major project. Performs analyses to develop process specifications. Provides technical information concerning manufacturing techniques, components, and test algorithms. Completes the following activities as requested: • Conceptualize new processes and testing methods using device knowledge and innovative thinking. • Develop manufacturing assembly procedures and fixturing using mechanical, electrical, and software engineering skills. • Develop test procedures and test equipment using mechanical, electrical, and software engineering skills. • Develop, review, and challenge product and process specifications. • Create product and test equipment drawings and/or models. • Participate in pFMEA activities. • Generate IQ/OQ/PQ protocols and reports for manufacturing equipment. • Review components for reliability, performance, and standardization. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction, quality improvements, and component obsolesence. • Review engineering change orders. • Run empirical and experimental analysis. • Work with outside consultants, vendors, and the medical community. • Conduct work in accordance with design control and quality system requirements. • Participate in design reviews. • Work on process design and development for new atrial fibrillation mapping, visualization, and recording systems. Required Qualifications: • Bachelor’s Degree in Engineering or Scientific discipline, advanced degree preferred. • 0-3 years experience, preferably in process development for electrical systems. • Experience with development of medical devices preferred. • CAD Experience in Solidworks and/or Altium preferred. |E-mail this position Submit Resume or C.V.2012-05-21 20:25:02United StatesSt. Jude MedicalCaliforniaAF13885CAIrvine, CA28837108http://jobs.sjm.com/xml/28837108/jobUSAAustinCredit & Collections Specialist, Sr Job Requisition #: USD 9596 Date Posted: 05/21/2012 Category: Collections Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working without appreciable direction, responsible for the most challenging and complex credit/collections accounts, while also mentoring, training and being the primary source of best practices validation for department associates. Evaluates problems with diverse variables requiring in-depth analytical skills; selects the most advantageous recourse for obtaining final solutions. This involves solving complex problems with multiple variables requiring comprehensive research and advanced problem solving skills. Requirements/Education: AA degree in Business Administration, Accounting, related field, or equivalent, plus a minimum of ten plus years of progressively more responsible credit and collections experience. Ability to exercise independent judgement in negotiations, dispute resolution, and counseling of hospitals regarding their delinquent accounts and options. A thorough understanding and expertise in the technical aspects and application of credit and collection techniques. Must possess comprehensive personal computer skills (experience with Microsoft Office including Excel, Word or equivalent applications required) and have experience working with an operating system (such as MFG/PRO, Oracle, SAP, Peoplesoft, etc.). Must have comprehensive written and verbal communication, interpersonal, negotiation, analytical, and organizational skills. Evaluation, originality and/or ingenuity required. Desired Requirements: Bachelors degree in a relevant discipline. Previous lead and collections experience in a manufacturing environment. Experience with CorVu, Access, Get Paid, and other accounting/collections reporting software. Work experience in a hospital, medical device manufacturing and/or medical sales environment is desirable. N/A |E-mail this position Submit Resume or C.V.2012-05-21 20:24:55United StatesSt. Jude MedicalTexasUSD 9596TXAustin, TX28837106http://jobs.sjm.com/xml/28837106/jobUSASaint PaulSr. Manager, Fellows and Key Opinion Leader Development, NMD Job Requisition #: USD 9610 Date Posted: 05/21/2012 Category: Training Location: Central - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview THIS POSITION CAN BE LOCATED ANYWHERE IN THE U.S. Fosters sales and market share gains through customer relationship development, SJM brand identification, and SJM product awareness. Supports educational initiatives. Activities are targeted both at Fellows and Key Opinion Leaders of specific specialties at targeted institutions. Sets goals, ensures that they are meet and is responsible for continuous process improvement. Communicates with Field Leadership to coordinate a broad USD effort to drive results. Utilizes best business practices to increase the chances for success and to assure cost effectiveness in areas of responsibility. Ensures full compliance with St. Jude Medical policies and practices. Requirements/Education: Required: A Bachelors or Masters Degree from an accredited university A minimum of six years of progressive industry experience consisting of increasing responsibility in sales, sales management, marketing, training, and customer education Excellent verbal and written communication skills Excellent interpersonal skills Ability and willingness to travel significantly Microsoft Office expertise |E-mail this position Submit Resume or C.V.2012-05-21 20:24:41United StatesSt. Jude MedicalMinnesotaUSD 9610MNSaint Paul, MN28837103http://jobs.sjm.com/xml/28837103/jobUSASt. PaulSr. Manager - Collaboration Services Job Requisition #: Corp 12038 Date Posted: 05/17/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview The Sr. Manager will be responsible for the overall direction and effectiveness of all centrally managed voice, data and video communications solutions. Oversee the strategic alignment of communication and social technologies used across the organization to drive effectiveness and productivity. Partner with the business to enhance adoption through the delivery of easily consumable technology solutions. Outstanding service delivery, operational excellence, customer satisfaction and high availability will be an expected part of this person’s expertise and mindset. The ideal candidate will be hands-on, results driven and comfortable in a fast paced globally diverse environment. Job Duties: • Provide strategic direction for all centralized collaborative technology efforts including telecom, messaging, video, web and audio conferencing • Confer with and advise executives, user representatives and technical personnel regarding overall service strategy and solutions • Partner with architecture to provide long range technology roadmaps in the collaboration space • Plan and manage budgets, forecasts, projects and associated staffing requirements • Work collaboratively across the client enterprise and with external partners to define and deliver high quality, effective solutions • Oversee both direct and indirect reporting relationships with global technical teams to ensure the highest level of competency and execution of business focused use of communication technology • Develop and encourage the growth of all direct and indirect reports through skills development, objectives and goal setting • Ensure the high levels of service delivery, systems availability, security controls and disaster recovery • Ensure the development of effective standards and the implementation of best practices for IT services • Provide metrics and statistics to measure the operational effectiveness of the responsible line functions. Propose and present recommendations to management, when necessary, to improve effectiveness Qualifications: • Bachelor’s degree in technical or business discipline, Master’s degree preferred • 10+ years’ experience in managing and maintaining communications based systems such as telephony, call centers, email and conferencing technologies • Strong interpersonal skills and communications skills • Ability to communicate effectively to both technical and business personnel at all levels of an organization • Proven project management/leadership experience with the ability to create innovative solutions and drive to closure, manage timelines/deadlines and foresee opportunities to improve and harmonize technology and business processes across sites, divisions, geographies, etc. and initiate appropriate action • Highly organized, capable of multi-tasking and capable of coordinating/aligning resources under an integrated project plan • Experience managing enterprise wide implementations of collaboration technologies from both the Cisco and Microsoft technology stacks • Negotiation and diplomacy skills for interfacing with customers and vendors • Experience developing high performing technical teams • Proven ability to make sound decisions in a timely manner • Demonstrated ability to lead project teams, manage resources and develop personnel • Ability to travel up to 20% including international travel |E-mail this position Submit Resume or C.V.2012-05-21 20:24:39United StatesSt. Jude MedicalMinnesotaCorp 12038MNSt. Paul, MN28837102http://jobs.sjm.com/xml/28837102/jobUSAPlymouthEngineer - Process Development Job Requisition #: 13302 Date Posted: 05/21/2012 Category: Process Development Engineering Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Description: A Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required. Focus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required. Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements. Education: Bachelor Degree in Engineering or Materials required. Experience/Skills: 1-5 years experience in process engineering/development of regulated products (medical devices preferred). Working knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.). Working knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&R preferred. Excellent data analysis and reporting skills. Excellent patience and communication skills. Experience with stainless steel and/or nitinol wire braiding preferred. Experience with nitinol material processing preferred. Experience with tool design and automation preferred. |E-mail this position Submit Resume or C.V.2012-05-21 20:24:32United StatesSt. Jude MedicalMinnesota13302MNPlymouth, MN28837099http://jobs.sjm.com/xml/28837099/jobUSADallasSr. Microbiologist Job Requisition #: NMD3203 Date Posted: 05/21/2012 Category: Microbiology Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview This position is for the microbiologist that consistently applies microbiological concepts to the manufacturing process of a medical device and understands and develops process monitoring/metrics to maintain microbiological quality of the final device. Essential Functions: • Provides Facility Microbiological Support o Record review of routine microbiological test results o Routine release of manufactured product o Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods. o Handles routine out of specification test results, or more complex out of specification issues. o Data analysis of sterilization processes. o Participate in audits of sterilization, test lab, and biological product vendors. • Documentation o Ensures correct documentation linkage flow for microbiologically related documents. o Writes new or updates current microbiologically related documents. • Maintains understanding of applicable standards and applies them to qualifications and test methods. • Writes protocols and reports for qualifications for sterilization and microbiological test methods. o Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation. o Develops sterilization cycles and laboratory test methods. o Works with technicians in conducting these qualifications. • Technical Training o Provides training to laboratory technicians on new equipment or new test procedures. o Provides training in the areas of sterilization validation and sterilization processes. • Authority to sign off Qualifications, DDAs, NCMRs, COs, FMEAs, PDP forms. • Member of R&D product teams, Operations project teams, or supports other projects as Directed by Department Manager. Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision: • This position requires minimal oversight by the manager. • This position may have supervisory responsibilities. Relationships: Internal: This position interacts with Microbiology technicians and other Microbiologists. Interactions also include engineers, project leads, and some exposure to upper management. External: This position will interact with outside suppliers, usually sterilization and laboratory companies. Equipment: Computer, temperature acquisition equipment, sterilizers, other laboratory equipment. Working Conditions: The majority of work occurs in an office environment, some work will occur in the laboratory. This position must be able to follow required gowning for entry to controlled access environments or safety equipment for certain laboratory conditions. Physical Demands: No exceptional physical requirements. Qualifications: • Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology. • With BS Degree: o Minimum of 7 years in a medical device/pharmaceutical, or related industry. Cumulation of 7 years of work experience in microbiology and sterilization. • With Masters Degree: o Minimum of 3 years in a medical device/pharmaceutical, or related industry, and cumulation of 4 years in microbiology and sterilization with a Masters degree in a scientific field. • Person in this position demonstrates professional skills • Articulates technical concepts well • Excellent written communication. • Person in this position has demonstrated troubleshooting skills in complex situations outside of routine out of specification issues, such as sterilization or contamination issues while at the Microbiologist II level |E-mail this position Submit Resume or C.V.2012-05-21 20:24:26United StatesSt. Jude MedicalTexasNMD3203TXDallas, TX28837096http://jobs.sjm.com/xml/28837096/jobUSAAtlantaAssociate Field Clinical Engineer Job Requisition #: AF13895 Date Posted: 05/21/2012 Category: Clinical Location: Atlanta - GA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a high caliber Associate FCE. Working under direct supervision on defined work assignments and/or following established procedures, performs field clinical engineering trainee duties. Throughout dedicated training time, completes the required educational requirements. During training will have rotations in the field, learns how to cover procedures, interacts with customers, and attains all of the basic competencies of an Associate FCE. Position will entail extensive training activities which may include: working in the field under the guidance and direction of experienced FCEs, and working on a variety of assignments as directed by the Manager, FCE. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating engineering work. Remains abreast of technical advancements. Impact this role will have within the AF division: • Assists the Primary FCE or FCE Manager with continuous technical support for all IDE Clinical Studies in the territory by providing case coverage, assisting with protocol, regulatory and data compliance. • Provides Clinical support by assisting with complex EP procedures using the Ensite system. • Assists with scientific research studies by providing field clinical support, data collection and collaborating with the field clinical organization. Required Qualifications: • BS in Engineering, Biological Sciences, a related field, or equivalent. • Requires the demonstrated ability to analyze and evaluate technologically complex devices; quantitative, analytical, organizational, multi-task, and follow-up skills. • The ability to meet deadlines on multiple projects/assignments as well as the ability to converse effectively with all levels of employees, management and customers. • Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with customers, physicians, hospital administrators, government agencies, medical groups, sales representatives, and other FCEs. • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. • Demonstrated personal computer skills including MS Office Suite, Excel, database management, and specialized applications. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Advanced credentials in a relevant discipline, preferably would include a strong knowledge of basic principles of cardiology and general research. • Demonstrated work experience in clinical research is also desired. |E-mail this position Submit Resume or C.V.2012-05-21 20:24:26United StatesSt. Jude MedicalGeorgiaAF13895GAAtlanta, GA28837097http://jobs.sjm.com/xml/28837097/jobUSAMinnetonkaSite Operations Director - CRMD Job Requisition #: CRT13050 Date Posted: 05/18/2012 Category: Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking an experienced, high caliber Site Operations Director to join our Minnetonka, Minnesota based Cardiac Rhythm Management team. Within this role, the Site Operations Director will have complete oversight responsibility for Research & Development (R&D), Engineering, Operational, and related activities to achieve operating plans for CRMD’s Delivery Systems operations. Impact this role will have within the CRM division: • Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth, and personal development. • Accountable for the staff development; critiques, instructs, mentors, evaluates, and coaches. • Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus. • Recommends, translates, and monitors the operations objectives for the site as well as delivery systems leadership to ensure staff acceptance, motivation, achievement and celebration of outcomes that meet production and the CRM Delivery Systems Site Operations overall objectives. • Collaborates with key customers to integrate the broad, overall objectives for manufacturing (including: productivity, product mix, material flow process control, inventory, delivery, and cost) and new product development into specific target levels/objectives. • Communicates objectives to managers and facilitates consensus on team activities and action plans required to meet these objectives. • Monitors the progress of functional departments towards meeting the objectives and providing ongoing feedback to managers on their results against objectives. • Facilitates and coach manager’s performance to ensure continual achievement of targets and operational objectives. • Facilitate the sharing of information with peers and senior site leadership and division leadership to result in the setting of mutual goals and resulting outcomes, coordination of actions and decisions with other CRMD site locations, as well as continuous improvement of the organization’s results and performance. • Provides continuous improvement engineering support to the site that result in the accurate identification, diagnosis, and solving of engineering-related problems, the appropriate prioritization and communication of projects and the achievement of overall operational and financial objectives for the unit. • Provides technical support and expertise to the manufacturing operations on an as needed basis to solve any problems and improve the manufacturing process. • Justifies and approves capital expense for replacement of existing equipment to increase capacity and enhance the manufacturing operations. • Monitors material levels and material flows to improve productivity, consistency in workflow, yield, improve quality, and to lower throughput and total inventory investment. • Ensures that new product development activities (i.e., R&D and Engineering) are completed on schedule, in budget, and are transitioned into manufacturing successfully. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a comprehensive knowledge of the company’s products, markets, and objectives as well as industry trends. • Maintains expert knowledge of current and novel catheter & related research, engineering, and manufacturing practices as well as quality initiatives through literature, trade journals, professional associations, and by attending conferences/seminars. • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. • Interacts with visiting customers, clients and VIP-s by providing tours, presentations and general business and technology updates for the site and industry. • Performs related functions and responsibilities, on occasion, as assigned. Required Qualifications: • Bachelor’s degree in Engineering or related field. Typically a minimum of • 10+ years of progressive management experience in a manufacturing environment. • Demonstrated knowledge and familiarity with cardiac or implantable delivery systems, their related technology, and associated processes. • Understanding and working knowledge with the following: Quality Systems Regulation (QSR), Good Manufacturing Practices (GMP) manufacturing practices, International Organization for Standardization (ISO) requirements, manufacturing automation, U.S. Food & Drug Administration (FDA) regulations. • Demonstrated leadership skills/experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor, and live within budgets as well as the demonstrated ability to forecast major milestones. • Significant experience with delegation, follow-up, and team building. • Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations. • Comprehensive verbal and written communication, analytical and problem solving skills, negotiation, judgment and decision-making, interpersonal, and presentation skills are essential. • Documented record of delivering research information that adds value to management's decision making process. • Comprehensive computer skills including demonstrated spreadsheet, word processing, statistical analysis, and presentation capabilities. • Excellent reputation for building relationships across various levels of an organization. • Energized attitude. Preferred Qualifications: • Master of Business Administration (MBA) or Masters in a Engineering or Management discipline. Demonstrated expertise with Cardiac Resynchronization Therapy (CRT) techniques and technology. • Previous experience running a world-class/total quality medical product manufacturing operation. • Individual and group training experience and certifications. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.2012-05-18 19:29:03United StatesSt. Jude MedicalMinnesotaCRT13050MNMinnetonka, MN28797951http://jobs.sjm.com/xml/28797951/jobUSANoneProduction Supervisor Job Requisition #: 13229 Date Posted: 05/18/2012 Category: Production Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Provided leadership to the production teams to deliver the business results and expectations on a day to day basis. This position requires elevated training in human resources/people skills, quality systems, and manufacturing processes. The position is responsible for ensuring that standard production processes are maintained and that production volumes and quality are met. Requirements/Education: Bachelor degree in engineering science (Industrial or Mechanical) or Business Administration (Industrial Management). Three to five years of prior supervisory experience in a medical device, pharmaceutical, or electronic industry preferred. Capacity to define problems collects data, establish facts and draw valid conclusions. Must have excellent interpersonal and team work skills. Must be bilingual (English and Spanish), computer literary (MSFT applications and MFG software) preferred Knowledge of ISO and quality systems. Knowledge of SAP a plus. Must have good people skills with the ability to energize and motivate a staff. |E-mail this position Submit Resume or C.V.2012-05-18 19:28:27United StatesSt. Jude MedicalNone13229NoneVirtual, USA28797925http://jobs.sjm.com/xml/28797925/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13887 Date Posted: 05/18/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-18 19:27:49United StatesSt. Jude MedicalMinnesotaAF13887MNMinnetonka, MN28797906http://jobs.sjm.com/xml/28797906/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13888 Date Posted: 05/18/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-18 19:27:49United StatesSt. Jude MedicalMinnesotaAF13888MNMinnetonka, MN28797907http://jobs.sjm.com/xml/28797907/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13889 Date Posted: 05/18/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-18 19:27:49United StatesSt. Jude MedicalMinnesotaAF13889MNMinnetonka, MN28797909http://jobs.sjm.com/xml/28797909/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13890 Date Posted: 05/18/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-05-18 19:27:47United StatesSt. Jude MedicalMinnesotaAF13890MNMinnetonka, MN28797905http://jobs.sjm.com/xml/28797905/jobUSASt. PaulManager - Manufacturing Engineering Job Requisition #: 13270 Date Posted: 05/18/2012 Category: Manufacturing Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Manages the planning and completion of manufacturing/production engineering projects., including the design and development of manufacturing processes, documentation, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Responsible for the mentoring and growth of engineers and technicians, financial planning and budgeting, supplier interaction and engineering support and cross functional partnership throughout the organization. Essential Functions: • Provide leadership to manufacturing engineering staff regarding project prioritization, process validations, and continuous improvements • Implement and manage resource planning and project management tools • Support continuing production and new product introductions • Monitor and evaluate project and department progress and results • Participate in cross-functional teams • Review and approve protocol and written reports • Drive continuous improvement of manufacturing engineering technical capabilities • Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis • Coach, manage and develop technical staff • Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations • Ensure a safe work environment consistent with OSHA requirements and St. Jude Medical Policies • Prepare departmental budgets and control expenditures to stay within spending limits Qualifications: • BS in Engineering or equivalent technical field • 10 years manufacturing experience, with 3 years of people management experience • Experience with statistical techniques (e.g., DOE, SPC) • Excellent people management and communication skills • Solid knowledge of GMP, ISO regulations. • Prior experience in medical device manufacturing is required • Travel US and OUS approximately 25% |E-mail this position Submit Resume or C.V.2012-05-18 19:27:41United StatesSt. Jude MedicalMinnesota13270MNSt. Paul, MN28797900http://jobs.sjm.com/xml/28797900/jobUSASt. PaulEngineer Principal, Manufacturing Job Requisition #: 13281 Date Posted: 05/18/2012 Category: Manufacturing Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Essential Functions: • Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality • Evaluation of production equipment • Production support and process validation • Interface with vendors for incoming components • Troubleshoot manufacturing process and equipment • Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes • Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. • Protocol and report writing • Generate and modify manufacturing process documentation • Work with cross functional teams as required • Develop and implement process improvements • May supervise and provide work direction to other engineers and technicians Qualifications: • Mechanical/Chemical Engineering degree required • 10 years manufacturing engineering experience • Medical device experience preferred • Strong analytical, problem solving and project management skills • Demonstrated leadership capability in team settings • Six Sigma certification preferred |E-mail this position Submit Resume or C.V.2012-05-18 19:27:41United StatesSt. Jude MedicalMinnesota13281MNSt. Paul, MN28797901http://jobs.sjm.com/xml/28797901/jobUSAMinnetonkaSoftware Quality Engineer II Job Requisition #: 12878 Date Posted: 05/01/2012 Category: Software Quality Control Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview The Software Quality Engineer II is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. This position focuses on testing and validation. Essential Functions: • Develop and conduct training of company personnel for the divisional software development and validation program. • Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. • Create and execute or direct software validation protocols traceable to system/software requirements. • Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. • Assist in the completion and maintenance of risk analysis, focused on software related risks. • Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. Qualifications: • BS degree in Engineering or Technical Field • 2-5 years Software Quality Engineering experience. • Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485 • Solid communication and interpersonal skills • Advanced computer skills, including statistical/data analysis and report writing skills • Advanced Information Technology and data mining skills. • Prior medical device experience preferred • ASQ CSQE certification desired |E-mail this position Submit Resume or C.V.2012-05-18 19:27:23United StatesSt. Jude MedicalMinnesota12878MNMinnetonka, MN28797887http://jobs.sjm.com/xml/28797887/jobUSASeattleTech Serv Specialist, EP Job Requisition #: USD 9601 Date Posted: 05/17/2012 Category: Clinical-Systems Engineering Location: Seattle - WA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under moderate direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving both AF and CRM products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Requirements/Education: Bachelors degree in Bio-Medical Engineering or related field required. Requires SJM Brady, Tachy, CRT, Ensite, and EP certification within 12 months of hire date. Requires HRS certification. A minimum of two plus years increasingly responsible experience in the cardiac pacing and related industries. Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol. Demonstrated advanced knowledge of cardiac pacing systems is also necessary. Must apply engineering skills and abilities to interpret and solve complex pacing ECGs. Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines. Must have the ability to concentrate on detail and work independently. Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively. Must possess comprehensive personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc., to develop presentation materials. Placement into this position requires written approval by the Area Vice President (AVP). |E-mail this position Submit Resume or C.V.2012-05-17 20:38:29United StatesSt. Jude MedicalWashingtonUSD 9601WASeattle, WA28770396http://jobs.sjm.com/xml/28770396/jobUSAAustinMgr, Sr Product Marketing Job Requisition #: USD 9618 Date Posted: 05/17/2012 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has primary management responsibility for developing systems, services and behaviors that will produce maximum results from targeted sales processes. Has a primary responsibility to ensure that specific marketing initiatives within a Product Division are aligned, implemented, and recorded as sales initiatives across all functional aspects within USD. Has collateral responsibility to identify opportunities to build sales in under-serviced markets, both current and future. Has responsibility for support to Product Division Marketing regarding product design, product development and ongoing product engineering. Has responsibility for the design and implementation of product-defined sales and manpower metrics with respective application to USD management. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. As a Sr. Manager, may provide leadership to less experienced Product Marketing Manager. Required: A Bachelor’s degree in Business Administration, Marketing or equivalent plus typically eight plus years of progressively more responsible business experience in a class III medical device company or equivalent, including product or market management experience. A minimum of four plus years of demonstrated experience at a supervisory/managerial level is typical. Seasoned judgment acquired through organizational experience and a demonstrated record of achievements in successfully building a business. A substantive knowledge of the heart medical devices, health care delivery, and managed care/reimbursement markets and the factors that drive them is required. A thorough understanding of product and market management, physician, and patient marketing is also required. Demonstrated ability to effectively prioritize development projects using customer input. Requires the ability to track financial metrics and make appropriate adjustments to successfully achieve revenue/unit goals. Documented record of delivering marketing information which adds value to management’s decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills; the ability to lead a cross-functional team. Demonstrated working knowledge of frequently used personal computer programs and applications, such as, Microsoft Office. Must be adept at handling multiple assignments and accomplish these projects within budgetary guidelines. Desired: An advanced credential, such as an MBA in a relevant discipline/concentration. Professional marketing certification or designation. Both US and international class III medical device marketing experience is preferred. |E-mail this position Submit Resume or C.V.2012-05-17 20:38:27United StatesSt. Jude MedicalTexasUSD 9618TXAustin, TX28770395http://jobs.sjm.com/xml/28770395/jobUSASylmarParalegal/Admin Asst. Job Requisition #: 13097 Date Posted: 05/17/2012 Category: Legal Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working under limited supervision, organizes, plans and performs a variety of secretarial, clerical, and administrative support duties, such as (but not limited to): receiving/screening/directing phone calls/faxes/e-mails; making travel arrangements; scheduling appointments; arranging meetings; preparing correspondence/reports/documents/presentations; collecting/distributing data; and maintaining paper/electronic filing systems. Takes initiative to improve work product and processes. May be accountable for reviewing work of less experienced employees for quality and content. Adapts existing work methods to different situations. Can resolve unusual, nonstandard problems; refers only significant deviations from approved policy/practice to supervisor or more senior level personnel for resolution. Requirements/Education: Paralegal certification.2 or more years of progressively more responsible paralegal experience. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Incumbents are required to work cooperatively and productively with others. Demonstrated organizational skills, attentiveness to detail, and the ability to work under general supervision is required. Must be adept at handling multiple assignments in a timely manner while meeting assigned deadlines. Must also have demonstrated verbal and written communication, interpersonal, organizational and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: Bachelor's. Must be a good listener, compassionate, detail-oriented and meticulous. Must be able to juggle many assignments at once. Must be a team player. Professionalism is of utmost importance. This person is part claims administrator and part warranty administrator. |E-mail this position Submit Resume or C.V.2012-05-17 20:38:19United StatesSt. Jude MedicalCalifornia13097CASylmar, CA28770393http://jobs.sjm.com/xml/28770393/jobUSAColumbusDirect Sales Rep, CRM Job Requisition #: USD 9612 Date Posted: 05/17/2012 Category: Sales Location: Columbus - OH - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Calls on physicians, medical laboratories, distributors, and hospitals to sell a variety of St. Jude Medical/USD medical devices in an assigned territory. May conduct marketing surveys, effectiveness reviews of calls/sales activities, and territory analysis. Services accounts, suggests and presents new products, and takes orders. As appropriate, assists marketing personnel on advertising and promotional sales strategies. Requirements/Education: Bachelors degree in a relevant technical field or equivalent and typically four plus years of progressively more responsible sales experience, including experience with medical devices. Working knowledge of domestic regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; and familiarity with medical device industry policies, operations and procedures. Documented record of delivering sales/marketing information which adds value to managements decision making process. Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives. Demonstrated verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated working knowledge of frequently used personal computer programs and relevant applications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiac rhythm management technology. |E-mail this position Submit Resume or C.V.2012-05-17 20:37:29United StatesSt. Jude MedicalOhioUSD 9612OHColumbus, OH28770369http://jobs.sjm.com/xml/28770369/jobUSALos AngelesDatabase Administrator (DBA), Senior Job Requisition #: 13195 Date Posted: 05/15/2012 Category: Information Technology Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview St. Jude Medical, Inc, is looking for a Sr. DBA to join this outstanding IT team! There are many interesting projects within the Security arena that this team member will be working on! Consider joining the IT team at St. Jude Medical! Summary As a part of the Information Technology (IT) organization, the Sr. Oracle DBA will maintain the divisions relational databases including both Decision Support Systems and Online Transactional Processing. • Installs, configures and upgrades database software on various platforms. • Responsible for providing and insuring data availability, data integrity, and data security. • Performs routine database administration functions including database capacity planning, pro-active performance monitoring and tuning, executing security procedures and backup and recovery processes. • Supports activities and acts as a member of and resource to various application development teams in the development, QA (Quality Assurance), and test/production environments. • Efficiently works with server administrators, application administrators, vendors and consultants. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or higher academic course of study. • Remains abreast of database advancements and offers recommendations for use of these technologies. Identifies and routinely uses the most effective and cost efficient best practices/technology to execute processes; continually evaluates their effectiveness and appropriateness. • Works closely with IT Security on special projects Qualifications Requirements/Education Bachelors Degree in Computer Science (CS), Computer Information Systems (CIS), Management Information Systems (MIS), a related field, or equivalent8 • 8 plus years of progressively more responsible Oracle database administration and design work experience. • In-depth knowledge and hands-on experience with: installation and maintenance of current or/and latest versions of relevant Oracle database software; • Experience supporting large-scale databases; expert knowledge and comprehensive application of advanced Structured Query Language (SQL) concepts including PL-SQL, database backup, and restoration methods/techniques; expertise in database modeling (logical/physical) and design; advanced knowledge of database administration and monitoring tools; demonstrated understanding of High Data Availability concepts and methods, specifically Oracle RAC, Oracle Replication and DR methodologies; • Requires excellent written and verbal communication; interpersonal, facilitation, presentation, quantitative, analytical, organizational and follow-up skills. • Have the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. • Documented record of delivering software engineering information which adds value to management decision making process. Demonstrated ability to understand and comply with all applicable regulatory and company operating procedures, processes, policies, and tasks. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: Knowledge of the Oracle Database security products will be considered an advantage. |E-mail this position Submit Resume or C.V.2012-05-16 19:44:03United StatesSt. Jude MedicalCalifornia13195CALos Angeles, CA28739040http://jobs.sjm.com/xml/28739040/jobUSASylmarProgrammer Analyst, Senior Job Requisition #: 13196 Date Posted: 05/15/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Sharepoint Administrator Working independently with rare managerial oversight and direction as a part of the Information Technology (IT) organization, creates and maintains business application systems. Performs all phases of systems and programming development and maintenance by preparing detailed specification from which programs will be written in support of the assigned project(s) or group(s). Works on large complex systems installations, including the development of system specifications and the resolution of complex systems and programming problems. Performs complex programming activities, system analysis; preparing specifications, testing strategies and documenting applications. Directs and performs all phases of systems design including costing. Performs analysis and recommends strategies, determines and develops technical solutions and mentors less experienced employees. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Initiates the planning, organizing, performing, coordinating and/or directing of database work. Performs technical studies. Remains abreast of and consults on business application system advancements. Identifies and routinely uses the most effective, cost efficient and best practices/technology to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of eight plus years of progressively more responsible systems analysis, design, programming and testing experience. A thorough knowledge of software systems architecture principles, as well as databases and procedural languages required. Demonstrated experience working on large or complex projects in a diverse team environment. Ability to translate client requirements into a feasible design solution. Comprehensive ability to use proper coding techniques and efficiencies, testing methodologies, with an understanding of the operating system. Demonstrated planning, organizational, interpersonal and communication skills. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. This includes bridging communication issues between technical areas and business areas for a full and complete understanding of expectations. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. Solid experience with SharePoint 2007 and 2010 administration and configuration. Deep understanding of the SharePoint platform, its application services and architecture. Have relevant experience with SharePoint design, architecture, availability, reliability and security for large environment. Broad knowledge of content management, knowledge management and collaboration concepts. Skillful in business analysis, project coordination, communication and documentation. Maintain smooth operation production and test SharePoint farms, including coordination with IT resources and business stakeholders. Responsible for tuning system performance, installing system wide software and patches. Provides backup and restore recovery. Develops and monitors system performance and trend Evaluate and determines source of problem and uses best judgment to correct them. Resolves and/or facilitates the resolution of problems effectively and efficiently including identifying their causes to prevent re-occurrence. Write or support efforts to generate and maintain technical documentation: user guides, application primers, systems and validation documents and systems Policies and Procedures. Maintain regular, reliable, and predictable attendance. Required to work after hour and weekend to complete projects and tasks if needed. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Must be a team player with excellent oral and written communication skills. Performs other essential functions and responsibilities as determined by the Company from time to time. |E-mail this position Submit Resume or C.V.2012-05-16 19:44:03United StatesSt. Jude MedicalCalifornia13196CASylmar, CA28739041http://jobs.sjm.com/xml/28739041/jobUSAWestfordEngineer - Research & Development Job Requisition #: 13223 Date Posted: 05/16/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Senior Applications Engineer PRIMARY DUTIES AND RESPONSIBILITIES: Lightlab Imaging, a subsidiary of St. Jude Medical, seeks a talented applications engineer to help develop the next generation of intravascular imaging systems. The successful candidate will have an external role understanding/supporting the customer and an internal role developing the new system. Externally, working with the marketing and clinical teams, they will be responsible for supporting operation of the imaging systems during preclinical and clinical investigations. As part of this effort they will look to understand the user needs and product limitations. Internally, working in the development team, they will help to merge the user needs and development realities into a finish product with a specific emphasis on the user interface, ease of use, and image processing. The job is based in Westford MA but will require significant travel (US and internationally) Additional responsibilities may include other SW development tasks EXPERIENCE & SKILL REQUIREMENTS: Degree BS/MS in Software or Biomedical Engineering with a SW or Image Processing Concentration. Experience (a combination of some of the following experiences is preferred) Clinical role in the cardiac catheterization lab Clinical or Technical experience with intravascular imaging (OCT, IVUS or FFR) Engineering Development experience in the clinical or pre-clinical setting User Interface Development Validation of medical imaging with histology Marketing Support for New Product development/introduction |E-mail this position Submit Resume or C.V.2012-05-16 19:42:26United StatesSt. Jude MedicalMassachusetts13223MAWestford, MA28738985http://jobs.sjm.com/xml/28738985/jobUSASylmarCo-op Job Requisition #: 13019 Date Posted: 05/01/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview The Co-op (i.e., Co-operative Education”) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the student’s university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses’ fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. 1) Good communication and teamwork skills for working with all levels of employment and outside vendors 2) Needs to know the basics of Word, Excel, and PowerPoint 3) Familiar with computer aid software such as Pro-engineering and Windchill 4) Knowledge of drafting techniques and tool design 5) Familiar with product life cycle programs (Teamcenter) 6) Proactive and willing to learn new things; Not afraid of new challenges 7) Ability to multi-task and switch to higher priority tasks with little notice |E-mail this position Submit Resume or C.V.2012-05-16 19:42:25United StatesSt. Jude MedicalCalifornia13019CASylmar, CA28738983http://jobs.sjm.com/xml/28738983/jobUSAPlymouthEngineer - Process Development Job Requisition #: 13243 Date Posted: 05/16/2012 Category: Process Development Engineering Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Description: A Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required. Autonomy: Individual contributor with a moderate to high level of day-to-day work direction from their supervisor. Work Content: Typical projects will be focused towards individual process technologies affecting one to many products. Process Engineers will usually be members of a larger project team. Job Accountabilities: Process Development /Operations: Focus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required.Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements. Supplier Responsibilities: May interface with component suppliers to resolve manufacturing and quality issues. Teamwork/Leadership: Work effectively in a cross-functional team environment as an extended team member. May provide work direction to technicians. May train manufacturing personnel.May be a core team member for a small project. Education: Bachelor Degree in Engineering or Materials required. Experience/Skills: 1-5 years experience in process engineering/development of regulated products (medical devices preferred). Working knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.). Working knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&R preferred. Excellent data analysis and reporting skills. Excellent patience and communication skills. Experience with nitinol preferred. Experience with tool design, injection molding, packaging, polymer joining/reflow, heat setting, and automation preferred. |E-mail this position Submit Resume or C.V.2012-05-16 19:42:14United StatesSt. Jude MedicalMinnesota13243MNPlymouth, MN28738978http://jobs.sjm.com/xml/28738978/jobUSAPortlandAssembler I Job Requisition #: PDX1024 Date Posted: 05/16/2012 Category: Assembly Location: Portland - OR - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The primary responsibility of the Assembler I is to ensure proficient assembly and packaging of medical devices while following company procedures and processes which meet or exceed quality and production standards. Essential Duties and Responsibilities: Perform a variety of assembly tasks including operating equipment, fixtures, and testers. Check for and report all non conformances. Follow written manufacturing procedures including SOP’s with no deviation. Perform in line inspection for every product. Comprehend and accurately complete necessary paperwork. Use of high resolution magnification and other equipment required to perform assigned job(s). Soldering. Other Duties: Assist in other manufacturing areas as needed. Train new assemblers to written procedures. Perform general housecleaning activities. Packaging, sorting, organizing Minimum Requirements/Qualifications: High School Diploma/GED or successful completion of comprehension screening. Some assembly experience preferably in a high tech environment. Experience in medical device manufacturing ideal. Demonstrated soldering skills using a high resolution microscope. Demonstrated comprehension and accuracy completing necessary paperwork. High level of attention to detail. Equipment: High resolution microscope. Test equipment. Fixtures. Computers, keyboards, printers. Various tools including; soldering irons, wire cutters, crimpers, wire strippers, screwdrivers, heat gun, continuity tester, measuring tools (rulers, tape measures), digital multimeter, heated tweezers. |E-mail this position Submit Resume or C.V.2012-05-16 19:41:43United StatesSt. Jude MedicalOregonPDX1024ORPortland, OR28738973http://jobs.sjm.com/xml/28738973/jobUSAMaple GroveSenior Manager Packaging & Labeling Development Job Requisition #: 13250 Date Posted: 05/16/2012 Category: Engineering Location: Maple Grove - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Maple Grove. Job Overview Position Summary: Manages the package design, product labeling, and technical publication functions to support both new product development and continuous improvement of existing packaging systems. Lead engineers, technical writers, and labeling specialists in the planning and completion of projects that impact new product introductions as well as global manufacturing and distribution center operations. Essential Functions: • Lead packaging and labeling design, testing, and validation efforts on all new product introductions. • Drive continuous improvement of packaging & labeling systems within both manufacturing operations and distribution centers. • Participate in or lead cross-functional product development and business system teams • Develop, implement, and monitor packaging & labeling systems and procedures to ensure compliance to FDA ( QSR / cGMP) and all other applicable global agency regulations • Prepare business and technical analysis, recommendations, reports, and presentations • Lead and develop to technical staff across multiple facilities and product lines. • Implement and manage resource planning and project management tools • Monitor, evaluate, and report project and department progress and results • Review and approve verification and validation protocols and reports • Prepare and manage departmental budgets • Ensure a safe work environment consistent with OSHA requirements and St. Jude Medical Policies Qualifications: • BS in Packaging Engineering, Distribution/Logistics Management, or equivalent packaging & labeling related field; advanced degree preferred • 10 years packaging & labeling related experience, with 5 years of people management experience • Solid knowledge of GMP, ISO regulations. • Prior experience in medical device package design, validation, manufacturing, & distribution center functions. • Prior experience in medical device and/or pharmaceutical labeling requirements • Prior experience in medical device identification coding (UDI, GS1, etc...) • Experience with statistical techniques (e.g., DOE, SPC) • Solid people management and communication skills |E-mail this position Submit Resume or C.V.2012-05-16 19:41:42United StatesSt. Jude MedicalMinnesota13250MNMaple Grove, MN28738971http://jobs.sjm.com/xml/28738971/jobUSASt. PaulExecutive Assistant, Finance Job Requisition #: Corp 12036 Date Posted: 05/09/2012 Category: Finance Administrative Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview In supporting the Executive Vice President and Chief Financial Officer, and the Vice President and Corporate Controller, this position will provide administrative support as necessary to ensure that objectives, milestones and timelines are met. This individual will interact with key internal and external stakeholders such as outside counsel, shareholders, board members. This executive assistant will prepare executive materials and presentations, and provide additional support as needed to the senior officers. Job Duties: • Manage the process and assist in the preparation and compilation of Audit Committee deliverables, including PowerPoint/overhead presentations, memos and presentation books • Collaborate with Finance and other Executive staff to complete Corporate Operating and Strategic Plans, including Board presentation books • Prepare executive meeting logistics and serve as the point of contact for the shareholders meeting and earnings release events on behalf of the Executive • Be responsible for coordinating with others in maintaining department budgets • Maintain confidential information • Effectively manage conflicting priorities by organizing work and collaborate with others, if applicable, to accomplish tasks. • Prepare and update memoranda, correspondence and reports as needed; Types, formats, proofread and revise memos, letters, reports and forms; Corrects grammar, errors and format; Drafts brief memos or letters of a routine nature • Provide general office support which may include, but are not limited to; mail distribution, answering telephones, filing, ordering supplies, etc. • Collaborate with Human Resources and Information Technology departments to onboard new finance or audit personnel • Provide administrative support on behalf of the executives with meeting arrangements, calendar management, travel arrangements (international and domestic), expense reimbursement, purchase orders, material preparation, catering arrangements and other administrative tasks as required • Other duties as assigned Qualifications: • High School graduate required, with advanced training through college, business school or other post high school training preferred. College degree in business or legal administration preferred • Minimum of 10 years experience supporting a Vice President or a C level executive at the top of a large public organization • Previous experience supporting the coordination of Board presentation materials required, including proficiency at presentation creation • General knowledge and experience working with company shareholders and analysts preferred. • Experience arranging and booking international and domestic travel. • Excellent proficiency of the Microsoft Office Suite products i.e. Word, Excel, Outlook and PowerPoint. Knowledge of Visio, Photoshop, Project and other graphics arts programs a plus • Proficient in the use of general office equipment (e.g. fax, copier, telephone, calculator, etc.) • Excellent interpersonal, written and verbal communication skills • Demonstrated ability to handle difficult situations and/or communications tactfully and professionally • Able to maintain strict confidentiality • Able to work with people at all levels of the organization • Ability to handle multiple priorities and operate with a sense of urgency as required • Possesses excellent judgment and the initiative to make independent decisions • Ability to work outside of standard business hours in support of Company functions as needed |E-mail this position Submit Resume or C.V.2012-05-14 19:32:34United StatesSt. Jude MedicalMinnesotaCorp 12036MNSt. Paul, MN28676575http://jobs.sjm.com/xml/28676575/jobUSAMinnetonkaManager - Machine Design Job Requisition #: 12436 Date Posted: 05/14/2012 Category: Operations Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: Manages the planning and completion of Machine Design engineering projects, including the design and development of automated equipment, tooling, and fixtures. Essential Functions: •Interface with internal customers to provide mechanical design support for Division’s equipment needs •Lead the creation and maintenance of an effective Equipment Development Process •Manage vendor relationships for procuring materials, services and equipment •Implement and manage resource planning and project management tools •Drive continuous improvement of machine shop, control engineering, and machine design engineering technical capabilities •Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis. •Coach, manage and develop technical staff •Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations •Ensure a safe work environment consistent with OSHA requirements and St. Jude Medical Policies •Prepare departmental budgets and control expenditures to stay within spending limits Qualifications: Education: •Technical Diploma (Automation, Machine Design, Industrial Controls, or equivalent); BS Engineering, Industrial Management, or equivalent degree preferred •10 years relevant experience with Engineering Degree or 15 years relevant experience with Technical Diploma. •Requires previous management or supervision of machine design staff (CAD, mechanical, controls, and software), tool makers, mold makers, and/or general machinist staff •Requires experience developing and administrating functional department procedures within the Medical Device Industry •Requires previous experience conducting technology assessments and developing tooling and equipment for plastic molding, device assembly, special processes. |E-mail this position Submit Resume or C.V.2012-05-14 19:31:51United StatesSt. Jude MedicalMinnesota12436MNMinnetonka, MN28676563http://jobs.sjm.com/xml/28676563/jobUSAMinnetonkaAssembler -1st Shift Job Requisition #: AF13876 Date Posted: 05/14/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-14 19:30:52United StatesSt. Jude MedicalMinnesotaAF13876MNMinnetonka, MN28676497http://jobs.sjm.com/xml/28676497/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13880 Date Posted: 05/14/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-14 19:30:52United StatesSt. Jude MedicalMinnesotaAF13880MNMinnetonka, MN28676496http://jobs.sjm.com/xml/28676496/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13877 Date Posted: 05/14/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-14 19:30:50United StatesSt. Jude MedicalMinnesotaAF13877MNMinnetonka, MN28676491http://jobs.sjm.com/xml/28676491/jobUSAMinnetonkaAssembler- 1st Shift Job Requisition #: AF13878 Date Posted: 05/14/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work overtime. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-14 19:30:50United StatesSt. Jude MedicalMinnesotaAF13878MNMinnetonka, MN28676492http://jobs.sjm.com/xml/28676492/jobUSAMinnetonkaEngineer - Process Development Job Requisition #: 13113 Date Posted: 05/14/2012 Category: Process Development Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: This position will design and develop manufacturing processes, tooling, and fixtures to support catheter based new product development and improve established production processes while enhancing productivity and product quality. Essential Functions: • Develop and implement new process and improvements • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment • Work with Product Development to ensure Design for Manufacturability • Provide technical mentorship to engineers and technicians • Conduct Process FMEAs and Process Validations • Interface with vendors for incoming components • Utilize tools like Gage R&R, DOE, Cp, Cpk, and SPC to improve processes • Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. • Generate and modify manufacturing process documentation Individual should: • Be innovative, resourceful, and work with minimal direction • Have excellent organization, problem solving, communication, and team leadership skills • Work effectively with cross-functional teams Education and/or Experience: • Mechanical Engineering degree required • 3+ years related experience • Medical device experience preferred • Strong analytical, problem solving and project management skills • Demonstrated leadership capability in team settings • Six Sigma certification preferred |E-mail this position Submit Resume or C.V.2012-05-14 19:30:08United StatesSt. Jude MedicalMinnesota13113MNMinnetonka, MN28676475http://jobs.sjm.com/xml/28676475/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: AF13869 Date Posted: 05/10/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 2nd shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-11 18:48:22United StatesSt. Jude MedicalMinnesotaAF13869MNMinnetonka, MN28634618http://jobs.sjm.com/xml/28634618/jobUSAIrvineAssembler - 3rd Shift Job Requisition #: AF13883 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 3rd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13883CAIrvine, CA28634580http://jobs.sjm.com/xml/28634580/jobUSAIrvineAssembler - 2nd Shift Job Requisition #: AF13884 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 2nd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13884CAIrvine, CA28634579http://jobs.sjm.com/xml/28634579/jobUSASunnyvaleEngineer, Senior Software Job Requisition #: 12499 Date Posted: 04/13/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Sylmar, CA. Job Overview Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as Development Engineering, IT Engineering, System Engineering, Test Engineering, and/or related areas. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software specifications as well as the troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs technical studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. A demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks is also required. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Specialized experience and/or relevant coursework related to the software applications, programs, and processes. Academic or in-house courses in project management, leadership, training, TQM, and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-05-11 18:45:08United StatesSt. Jude MedicalCalifornia12499CASunnyvale, CA28634552http://jobs.sjm.com/xml/28634552/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: AF13870 Date Posted: 05/10/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 2nd shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-10 18:16:11United StatesSt. Jude MedicalMinnesotaAF13870MNMinnetonka, MN28604522http://jobs.sjm.com/xml/28604522/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: AF13871 Date Posted: 05/10/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 2nd shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-10 18:16:06United StatesSt. Jude MedicalMinnesotaAF13871MNMinnetonka, MN28604520http://jobs.sjm.com/xml/28604520/jobUSADallasSr. Firmware Engineer Job Requisition #: NMD3200 Date Posted: 05/10/2012 Category: Electrical Engineering Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview This is a key position for a Firmware Engineer, who will design and develop best-in-class implantable and external medical devices in the field of neuromodulation, for the treatment of chronic pain and neurological disorders. With oversight and direction from the group manager, the successful candidate will work within a group of highly skilled technical individuals, in an interactive and collaborative environment, where excellence is the norm and customer satisfaction is paramount. Armed with excellent technical skills in computer science, she or he will be responsible for designing, analyzing, testing, and documenting products, as well as nurturing our culture of innovation and commitment to quality. Major, On-Going Responsibilities: • With the project execution plan and schedule as the guide, participate in firmware design and development activities, including detailed design, analysis, integration and test of C, C++ for real-time (time-critical) embedded systems designs • Detailed firmware designs for low power, mixed signal embedded systems for implantable medical devices • Modification and maintenance of implantable medical devices • Create, edit, and maintain documentation related to design controls and quality system guidelines • Remain current with firmware technologies and their applications in medical devices, particularly in the neuromodulation field, by monitoring industry events and literature • Strive for excellence, and help others achieve excellence, by promoting our core values, helping nurture a culture of quality and customer satisfaction • Utilizing the knowledge and insight from new and emerging technologies, participate in improving firmware design procedures and techniques, enabling the organization to develop products with higher safety, efficacy that provide the utmost in customer satisfaction • Assist the team in studies on functional and parametric (i.e. timing) product performance • Participate in activities related to product and process improvements, product life cycle extension and expansion, bolstering the reach of life changing medical technologies and products • Maintain an innovative and fun work environment Experience & Training: • A strong technical foundation, with a Bachelor’s in Electrical Engineering, Computer Science or related degree; Master’s degree is desired or related experience • A minimum 5+ years work experience in low power, mixed signal-embedded systems development, in a highly regulated development environment such as FDA, with hands-on participation successfully completing two or more complex engineering projects from concept to production release would be desirable • 5+ years of industry experience in analog and digital (embedded systems) development, including firmware, unit and systems level testing and integration activities • Embedded low-power microcontroller hardware design • Experience with mixed signal processors, such as the MSP430 • Excellent communications and interpersonal skills • Proven ability to take initiative Other Skills/Characteristics: • Individual must be highly motivated and resourceful • Individual must possess excellent interpersonal skills and have demonstrated ability to motivate technical personnel • Exemplary analytical, organizational, written and oral communication skills are a must |E-mail this position Submit Resume or C.V.2012-05-10 18:15:14United StatesSt. Jude MedicalTexasNMD3200TXDallas, TX28604487http://jobs.sjm.com/xml/28604487/jobUSADallasSenior Mechanical Engineer Job Requisition #: NMD3199 Date Posted: 05/10/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Technical design/project leader for the Neuromodulation implantable device market specifically in the area of Deep Brain Stimulation projects. Create technical product design for implantable devices using Solidworks or equivalent CAD software. Major Ongoing Responsibilities • Develop and maintain the contents of all design documentation in accordance with design controls and industry regulations • Work closely with a cross functional and departmental design team to create world class product and procedural solutions • Responsible for developing mechanical product testing, creation of test protocols/reports, and other product development deliverables • Work closely with marketing to define product ideas and requirements, and working closely with physicians in the field when required Experience & Training • Must have at a minimum of a Bachelor's of Science in Mechanical or Biomedical Engineering, or defendable equivalent experience • Minimum 6 years design experience required, and experience within the medical device industry strongly preferred • Must have experience in SolidWorks or equivalent • Must have excellent personal, written, and presentation skills • Must be a self-motivated problem solver with a passion for solving technical challenges in the medical device space |E-mail this position Submit Resume or C.V.2012-05-10 18:15:13United StatesSt. Jude MedicalTexasNMD3199TXDallas, TX28604485http://jobs.sjm.com/xml/28604485/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: AF13873 Date Posted: 05/10/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 2nd shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-05-10 18:14:45United StatesSt. Jude MedicalMinnesotaAF13873MNMinnetonka, MN28604469http://jobs.sjm.com/xml/28604469/jobUSASt. PaulMgr., Service and Support Center Job Requisition #: Corp 12032 Date Posted: 04/26/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview The Manager, Service and Support Center is responsible for the design, implementation, and management of St. Jude Medical’s enterprise-wide Service Desk and Desk Side Support organization. The Manager, Service and Support Center develops service level agreements, acquires the staff and tools necessary to execute those agreements, monitors performance of the service organization against the agreements, and actively engages the business units to seek ways to improve service delivery. Job Duties: • Oversee the day-to-day activities of the enterprise-wide SJM IT Service and Support Center group • Manage Service and Support Center staff directly, including scheduling to ensure support service coverage at all scheduled times; develop process and procedures for transition at start and end of shift to ensure continuity of work in process by the Service and Support Center staff • Perform daily oversight of all service request tickets; audit the status, completeness and accuracy of the service request tickets • Develop and maintain procedures and standards for high customer service levels; develop metrics, develop and maintain procedures for review and continuous improvement of performance • Strategically plan, implement and review innovative changes to the Service and Support Group’s organization and environment, that proactively anticipates and satisfies customer service needs • Collaborate with business line managers to review and improve quality and timeliness of service request resolution/completion • Identify persistent or recurring problems and recommend solutions that improve the business service • Oversee the function of asset management and policies for mobile devices, including vendor contracts • Integrate disparate teams around the globe, driving more synergy across these global teams as a base model for global support • Build processes to reduce and maintain a global first call resolution of 80% • Trains, coaches, and mentors Supervisors and other staff as needed • Implements improvements to support desk functions as needed, including initiating projects that enhance the quality and efficiency of the team • Actively research and make recommendations for improvements in IT operations generally and in Service and Support Center operations specifically • Keep management promptly informed of issues that affect the successful execution of the Service and Support Center’s responsibilities • Build successful relationships with the business areas being supported and actively increase business knowledge of the area • Take an active and collaborative approach to building solutions, ensuring they are pragmatic and have solid business case • Thoroughly research issues then present solutions to problems • Develop and practice solid communication skills in order to clearly articulate an issue and make it comprehensible to both technical and non-technical audiences • Manage relevant vendor and 3rd party relationships, as assigned • Actively pursue opportunities to increase the required skills for the job • Other duties that may be assigned Qualifications: • Bachelor’s degree in Computer Science, Management Information Systems, or equivalent degree and 7+ years of experience in IT • 4+ years of management experience in a Service and Support Center environment • Must have proven skills in customer support, employee supervision, and management of a service and call center organization supporting diverse international environments; familiarity with ITIL concepts and techniques for support services • Experience with SAP in an FDA regulated industry (ex: Pharmaceuticals or Medical Devices) is preferred • Experience with BMC’s Remedy software is preferred • Demonstrated experiences in providing guidance and coaching to direct reports • Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently • Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines • Proven project management/leadership experience with the ability to create innovative solutions and drive to closure, manage timelines/deadlines and foresee opportunities to improve and harmonize business processes across sites, divisions, geographies, etc. and initiate appropriate action • Exhibit the ability to work effectively across all of SJM and to build positive working relationships based on mutual respect • Excellent verbal and written communication skills with the ability to influence within and across organizations, functions and business areas • Highly organized, capable of multi-tasking and capable of coordinating/aligning resources under an integrated project plan • Ability to travel, up to 20%, including internationally |E-mail this position Submit Resume or C.V.2012-05-10 18:14:08United StatesSt. Jude MedicalMinnesotaCorp 12032MNSt. Paul, MN28604423http://jobs.sjm.com/xml/28604423/jobUSASt. PaulProgram Manager Job Requisition #: AF13864 Date Posted: 05/04/2012 Category: Program Management Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Program Manager. The candidate will provide Program Management leadership to assure effective execution of complex medical device development projects through the Product Development Process (PDP). The candidate will lead activities to develop new medical products from initial concept through commercialization using the procedures of the Product Development Process. This position works cross-functionally and across Division entities as required with core team and functional managers to ensure that projects meet objectives and timelines. The Program Manager will also be developing metrics to assess the health of the development programs and work closely with the Core Team Leads and Functional Managers to drive standard practices through the business. Impact this role will have within the AF division: • Meets with R&D engineering and marketing staff to clearly define product requirements. • Holds team members, functional management, and the organization accountable to tactical and strategic divisional objectives. • Leads development and deployment of a robust methodology for product development. • Prepares information for the monthly program review board meeting. • Provides timely, accurate updates to management. • Trains, coaches, mentors, and evaluates team members and support group personnel to enhance the probability of successful project completion. Required Qualifications: • BA or BS with a major in math, engineering, life sciences, business, or other relevant degree required. • 2 years of program/project management experience in the medical device industry is required. • Formal training in Program/Project Management or a Project Management Professional Certification is required. • Proven track record of successfully managing cross functional projects to introduce new medical products globally. • Must have demonstrated written and verbal communication, interpersonal, and presentation skills. • Must be able to demonstrate successful leadership and organizational skills. • Must be able to operate effectively in matrix organizations. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • An MBA or other related advanced degree is preferred. • Experience with software, capital equipment and sterile disposables desired. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:52United StatesSt. Jude MedicalMinnesotaAF13864MNSt. Paul, MN28574460http://jobs.sjm.com/xml/28574460/jobUSAAustinDir, Business Analysis & Development Job Requisition #: USD 9616 Date Posted: 05/09/2012 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has management responsibility for developing tools, methods, services and programs that will produce needed market research and customer preference and segmentation. Has a primary responsibility to ensure that specific market research initiatives across USD product areas (AF, CSD, CRM, and CD) are developed, implemented, and leveraged to help drive sales and share capture across all functional aspects within USD. Has primary responsibility to develop and implement USD market model for all product lines. Has primary responsibility to develop, communicate and coordinate feedback from sales analysis, metrics and scorecards to highlight key areas of business focus across product lines (CRM, AF, CVD, CSD) to Senior Sales and Marketing Management within USD. Has supporting responsibility to prepare market and sales analysis in support of annual Strategic and Operating Planning processes. Has collateral responsibility to identify opportunities for and to work with sales and marketing management to build sales programs in areas and markets, which are identified as providing untapped or under penetrated growth opportunities. Has responsibility for support to USD Marketing primary and secondary market research execution to provide input regarding product design, product development and ongoing product engineering based on customer specific needs. Has responsibility for the design and implementation of product-defined sales and manpower effectiveness metrics and communication to USD management. May also work on acquisition/merger analyses/evaluations as needed. Working closely with the Senior Vice President, Marketing, this position will have responsibility to lead and manage the newly formed oversight activities of U.S. organization partnership contracts and relationships. For current relationships, this area of responsibility will include familiarity with contract terms and conditions, along with insuring compliance, monitoring and managing the status and effectiveness of current programs and maintaining ongoing communication between the orgaziations. For potential new relationships, this position will be responsible for coordinating the evaluation of potential strategic fit, opportunity diligence and internal coordination with the USD management team for the purposes of development of a recommendation as to whether to pursue a potential collaboration.. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. Required: A Bachelor’s degree in Business Administration, Marketing or equivalent plus typically eight plus years of progressively more responsible business experience in a class III medical device company or equivalent, including product or market management experience. A minimum of two plus years of demonstrated experience at a supervisory/managerial level is typical. Seasoned judgment acquired through organizational experience and a demonstrated record of achievements in successfully building a business. A substantive knowledge of the medical device industry, health care delivery, and managed care/reimbursement markets and the factors that drive them is required. A thorough understanding of product and market management, physician, and patient marketing is also required. Demonstrated ability to effectively prioritize development projects using customer input. Documented record of delivering marketing information which adds value to management’s decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills; the ability to lead a cross-functional team. Demonstrated working knowledge of frequently used personal computer programs and applications, such as, Microsoft Office. Must be adept at handling multiple assignments and accomplish these projects within budgetary guidelines. Desired: An advanced credential, such as an MBA in a relevant discipline/concentration. Professional marketing and/or market research certification or designation. Both US and international class III medical device marketing experience is preferred. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:49United StatesSt. Jude MedicalTexasUSD 9616TXAustin, TX28574459http://jobs.sjm.com/xml/28574459/jobUSASylmarMicrobiologist, Staff Job Requisition #: 13130 Date Posted: 05/09/2012 Category: Microbiology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs a range of specialized duties in the Microbiology Lab to support sterilization validation activities, verify clean-room and environmental systems, and verify biocompatibility of materials. Work requires application of theoretical principles, evaluation, ingenuity and creative/analytical microbiological techniques acquired in a recognized four-year or more course of specialized study. Evaluates results and determines future courses of action to resolve problems. Exercises an appropriate level of independent technical judgment in planning, organizing, performing and coordinating assignments: leads tasks, projects, and microbiology programs; monitors performance and reports status to manager. Work is reviewed for soundness of judgment and overall adequacy/accuracy. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Assures that quality of services meets internal and external customer requirements. Remains abreast of all applicable advancements in field of specialty. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective cost efficient and best practices to execute processes. Requirements/Education: Bachelor of Science degree Microbiology or a related academic field. A minimum of three plus years of progressively more responsible work experience in the pharmaceutical or medical device industry; experience with environmental monitoring, and materials biocompatibility testing. Demonstrated research and investigative skills. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering microbiological information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, work processing, database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement, and various technical applications as noted above. Experience in a regulated medical industry. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:43United StatesSt. Jude MedicalCalifornia13130CASylmar, CA28574457http://jobs.sjm.com/xml/28574457/jobUSAPlymouthIntern, R&D (Summer & Fall Semesters) Job Requisition #: 13031 Date Posted: 05/01/2012 Category: Internship Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Summary: As a R&D Intern, you will provide technical engineering to support product development and transfer of innovative, minimally invasive medical products. You will work individually or with a group of engineers on the design, development, testing and documentation following in-place design control procedures. In this role you will generate the necessary documentation to convey design intent, including drawings, materials specifications, and test data to support regulatory submission of these devices. Duties and Responsibilities: • Construction and evaluation of prototype medical devices • Writing protocol and reports • Perform design verification and validations testing • Develop tooling and fixturing for testing • Generate/ECO engineering documentation, including drawings, materials specifications, manufacturing procedures, BOM's, inspection procedures. Qualifications: • Current student pursuing a Mechanical or Biomedical Engineering degree, or other related engineering degree – Must be enrolled in the 2012 fall semester • Strong communication, record keeping and problem solving skills. • Demonstrated creativity and "hands on" prototyping skills - ability to prototype devices that have been conceptualized. • Working knowledge of ISO, GMP and QSR; FDA experience a plus. • Computer proficiency with Microsoft applications. • Ability to interact with a range of personalities. • Ability to take initiative and work independently Assignment: Full-timeSummer, continuing Part-time Fall Semester Please Note: No housing, transportation or relocation allowance provided |E-mail this position Submit Resume or C.V.2012-05-09 18:01:42United StatesSt. Jude MedicalMinnesota13031MNPlymouth, MN28574456http://jobs.sjm.com/xml/28574456/jobUSASylmarProgrammer, Senior Job Requisition #: 13168 Date Posted: 05/09/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working without appreciable direction, provides ongoing support to all new and existing MIS operating systems. Develops advanced requirements, workflow and systems analysis. Corrects complex programming errors, prepares operating instructions, compiles documentation of program development, and analyzes system capabilities to resolve questions of program intent, output requirements, input data acquisition, programming techniques, and controls. Requirements/Education: Bachelors Degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of eight plus years of progressively more responsible experience with operating systems and databases, including demonstrated experience with C, C++, Visual Basic, Java, MSAccess, Oracle or UDB is highly desirable. (E-commerce applications include.ASP, NT, Visual Basic, SQL Server). Extensive technical knowledge; utilizes very complex computer operations (i.e., advanced programming in 3rd and 4th generation languages, relational databases, and operating systems) and advanced features of software packages (i.e., word processing, spreadsheet, graphics, etc.). Understanding of proper coding techniques, efficiencies and testing requirements. Understanding of job control language, the operating system and file access methods. Proficient in debugging techniques and technical problem analysis, SAS programming and expertise with UNIX, Windows, OS. Demonstrated planning, organizational, interpersonal and communication skills. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. This includes bridging communication issues between technical areas and business areas for a full and complete understanding of expectations. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:15United StatesSt. Jude MedicalCalifornia13168CASylmar, CA28574453http://jobs.sjm.com/xml/28574453/jobUSAMinnetonkaSAP Release Manager Job Requisition #: Corp 12035 Date Posted: 05/08/2012 Category: Information Technology Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview The SAP Release Manager position is responsible for three primary areas within the SAP program at SJM which includes: coordinating and managing the enhancement release schedule for an enterprise-wide SAP environment which includes ECC, CRM, GTS, SCM and BW components, responsibility for the change control processes and procedures and responsibility for cutover management and implementation releases. Job Duties: • Works with senior leaders across the organization in designing and supporting key change, release and cutover processes in SAP • Works independently in developing and maintaining key business relationships with business and EIT stakeholders. Develop strategies to overcome barriers when necessary • Establish clear objectives for project teams that are frequently assessed in regards to meeting user requirements • Manage professional and non-exempt employees, conducting work performance reviews and ensures work performance is adhering to Company standards. Mentors, trains and develops staff • Manages the detailed enhancement release activities to successfully migrate enhancements, patches, upgrades, support packs, etc. through the testing and promotion process to production. Appropriate decisions will need to be made to ensure a high-quality, highly reliable production environment in support of the enterprise. Ensures all program procedures are appropriately followed • Manage the execution of modifications to the production and pre-production environments throughout the St. Jude Medical SAP environment. This includes application changes that are part of the software development life cycle as well as network, servers, storage, databases and other infrastructure modifications • Works with the SAP GCC and EIT PMO teams to develop detailed cutover plans including considerations for business outage windows • Manage the timeliness, quality and completeness of deliverables to ensure the project or initiative moves forward per the established time lines and requirements. • Management of employee and contract resources in the delivery of change, release and cutover services • Coordinate with all teams in the program on all project related activities including resources and work assignments; o Monitor the development of process deliverables o Ensure the quality and completeness of deliverables • Ensures a successful release through close coordination with functional, development, and infrastructure resources within the program • Utilize sound judgment in evaluating enhancement readiness for Production. • Prepare detailed project plans, work plan development, communication plans, project control & coordination and drive execution • Track and report project status on a regular basis including identifying, categorizing and escalating project issues that require management attention. • Monitor and report on release status to management • Work closely with IT and business sponsors in the assessment and prioritization of proposed enhancements to the SAP solution • Responsible for overseeing and optimizing IT change control policies, standards, processes that meet business and compliance requirements, mitigate risks and ensure minimal outages • Develop appropriate compliance mechanisms to ensure all stakeholders including senior management adhere to the Change Control policies, standards and processes • Communicate with the business, project teams and external parties regarding processes and change control issues. Coordinate the implementation of corrective actions when required • Facilitate and support change management review meetings and change advisory boards to coordinate activities • Other duties as assigned Qualifications: • Bachelor’s degree in computer science or equivalent field. An MBA or advanced degree is desirable • 8+ years’ experience in IT or equivalent business experience working with business systems • 5+ years of SAP experience to include at least 2 years directly managing SAP projects, releases and go-lives • Strong understanding of SAP Change control mechanisms including SAP transports and Solution Manager preferred • Knowledge of SAP and the various SAP modules • 4 years in a managerial capacity managing small to medium sized teams which include employees and consultants • Well developed planning, organizational, and problem-solving skills. Must be accomplished in managing very detailed project plans • Highly organized, capable of multi-tasking and capable of coordinating/aligning resources under an integrated project plan • The ability to make objective and timely decisions under difficult circumstances. • Excellent analytical skills that are demonstrated by the ability to organize thoughts and ideas in a logical manner • Excellent verbal and written communication skills with the ability to influence within and across organizations, functions and business areas. Able to present and defend decisions across business units • Highly developed business acumen with working knowledge/understanding of business processes • Proven project management/leadership experience with the ability to create innovative solutions and drive to closure, manage timelines/deadlines and foresee opportunities to improve and harmonize business processes across the project team and initiate appropriate action • Ability to travel up to 25% including the potential for travel outside the US |E-mail this position Submit Resume or C.V.2012-05-09 18:01:13United StatesSt. Jude MedicalMinnesotaCorp 12035MNMinnetonka, MN28574451http://jobs.sjm.com/xml/28574451/jobUSAPlymouthEngineer - Research & Development Job Requisition #: 13134 Date Posted: 05/08/2012 Category: Engineering Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary We are seeking a high caliber, experienced, hands-on Senior Product Development Engineer that is innovative in driving new product development for our Minnesota based Cardiovascular division team. This is a high profile position that will work with a team of engineers to develop and commercialize new medical devices and delivery systems. Duties and Responsibilities: • Generates novel design ideas, builds prototypes,develops and refines design concepts • Generates test data and performs analysis to make design decisions • Works with suppliers and customers • Develops design specifications based on customer feedback and intended clinical use • Develops and refines test methods and models • Plans and executes design characterization, verification, and validation builds and testing • Generates and manages design documentation Technologies: •Biocompatible material selection for delivery systems and implants •Bioprosthetic implants •Mechanical design of biocompatible metals and plastics •Machining •Molding •Nitonol •Extrusion •Thermoforming •Packaging and Sterilization Qualifications: • Bachelor's degree in Mechanical or Biomedical Engineering • 5+ years of product development (R&D) experience • 5+ years of medical device development experience • Endovascular device and delivery system design experience • Experience with statistical data analysis and design of experiments • CAD design and drafting experience • Proven leader in a cross functional environment • Polished communicator • Excellent documentation writing skills; clear and concise using objective evidence and language • Excellent reputation for building relationships • Organized, on-time, and detailed project management skills • Energized attitude |E-mail this position Submit Resume or C.V.2012-05-08 18:57:29United StatesSt. Jude MedicalMinnesota13134MNPlymouth, MN28541769http://jobs.sjm.com/xml/28541769/jobUSAPlymouthTechnician - Desktop Support Job Requisition #: 13135 Date Posted: 05/08/2012 Category: Information Technology Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary: The Desktop Support Technician I role operates as a first level of IT support within the Cardiovascular IT organization. This position focuses primarily on the level 1 support aspects of PC hardware, software and end user issues. This role will regularly interacts with both technical and business individuals, and has frequent direct contact with all levels of business users, ranging from manufacturing employees to executives. A professional appearance, service oriented demeanor, and good customer service skills are required. Overall work direction is given from the desktop support supervisor as well as the IT manager, however day to day guidance is also provided by the level II and senior desktop positions. The ability to escalate more involved technical issues to higher level technicians is important. Essential Functions: • Physical installation of PC's and related peripherals. • Perform warranty replacement on PC hardware. • Work with client images for deployment of operating systems to desktops. • Participate in deployment and support of applications, software, end user hardware in accordance with technology standards. • Provide level 1 support of both hardware and software issues. • Manage service requests using the incident management application. • Maintain documentation on procedures as required. • Support LAN connectivity from the workstation to the network switch for all client end points. Other Duties: • Participate as a project resource as necessary. • Assist in testing of updates within defined change control processes. • Effectively prioritize and execute tasks as directed by the desktop support supervisor. • Participate in cross divisional IT efforts as deemed necessary. Qualifications: • 1-3 years related IT support experience, or 2 - 4 year degree in related IT field desired. • Microsoft Certified Technical Specialist (MCTS) or IT Professional (MCTIP) in Microsoft Windows Operating System or Microsoft Office technologies a plus. • Experience in supporting manufacturing and clean room environments also plus. • Solid technical aptitude and troubleshooting skills. • Solid understanding of standard PC and related hardware. • Excellent communication and customer service skills. • Ability to communicate with both technical and non-technical individuals. |E-mail this position Submit Resume or C.V.2012-05-08 18:57:29United StatesSt. Jude MedicalMinnesota13135MNPlymouth, MN28541771http://jobs.sjm.com/xml/28541771/jobUSASt. PaulInternational Product Manager- Vascular Products: Renial Denervation, Hemostasis & Specialty Devices Job Requisition #: ID11733 Date Posted: 02/17/2012 Category: Marketing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN: Job Overview POSITION SUMMARY Identify, develop and execute Product Marketing commercialization plans for Renal Denervation, Hemostasis, and Specialty Devices products sold globally. Act as a key interface between our International Customers, our geographic sales teams and the Product Division. Be responsible for the development of specific marketing plans and activities for specific products to establish, enhance or distinguish product placement within the competitive arena. Develop business plans and product positioning in the marketplace. Oversee market research, monitor competitive activity, and identify customer needs. Establish pricing strategies. Interface with engineering, manufacturing, and sales to develop new products or enhance existing products. TYPICAL DUTIES AND RESPONSIBILITIES •Plan and prepare product launches in cooperation with the Product Division /International Marketing and facilitate implementation throughout the geographies. •Evaluate strategies for product launches to ensure products are properly positioned and that brochures, sales sheets and supporting materials will launch products successfully and stimulate sales. •Develop recommendations on translating data collected on customer needs into engineering measures to evaluate product’s performance. •Develop recommendations on appropriate process for new products and on pricing and positioning strategies. •Prepare monthly new product launch updates for assigned products including metrics, strengths, gaps, strategies to close gaps, etc. •Provide analyses that highlight sales opportunities, trends and issues. •Provide rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal) •Contribute to the development of the International Division's annual strategic plan and operating plan •Develop marketing materials outside of new product launches •Develop obsolescence strategy to manage complete product portfolio •Represent the company by visiting accounts in order to solicit feedback on company products and services. •Develop appropriate strategies and plans in order to monitor and respond to changes in the market place, competitors, and performance versus objectives by major geography. •Work with the marketing manager to represent the Global viewpoint in the new product development process. •Determine clear and specific priorities for the development of new products and product enhancements by defining customer needs and working with other internal functional groups. •Rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal). •Contribute toward the development of an annual departmental budget by forecasting future needs, utilizing previous year’s budget, current objectives and budget guidelines. MINIMUM QUALIFICATIONS •Bachelors degree in business, sciences, or nursing required •2+ years or marketing experience within Medical Device Industry including market plan development and execution, working effectively in a complex, multi-tasking environment •Previous experience managing multiple, simultaneous new product launches required •5+ years experience using spreadsheets, databases and presentation software •Strong oral and written communication skills, influence management skills and negotiation skills, while remaining sensitive to cultural differences •Strong analytical, strategic and problem-solving skills required •Strong individual self starter who has ability to develop and execute on plans •Strong conflict resolution skills to achieve results through cross functional groups •Strong team player—ability to work as a key member of the International Division marketing team. •Strong leadership skills—ability to function as the marketing lead” on high profile projects around the world •Project management skills—ability to manage complex projects and programs. Ability to pull the appropriate functional and geographic functions together to support initiatives •Ability to distinguish between Objectives, Strategies and Tactics •Knowledge/experience with customer base •Understanding of medical products clinical and regulatory process and environments PREFERRED QUALIFICATIONS • MBA with marketing emphasis preferred • 2+years sales experience •2+ years of experience in Interventional Radiology •2+ years of experience in Interventional Cardiology (secondary) •Previous experience collaborating with international marketing and sales teams TYPICAL DUTIES AND RESPONSIBILITIES •Planning and preparing product launches in cooperation with the Cardiovascular product division and facilitating implementation throughout the geographies. •Working with the geographies to create post-launch programs to extend product launches •Creating programs designed to strengthen leadership in a mature market and to enter new markets through building loyalty for SJM. •Providing account analyses that can highlight sales opportunities, trends and issues. •Helping the geographies maximize regulatory, health economic and reimbursement opportunities •Working with the product division to represent an International viewpoint in the new product development process. •Monitoring and responding to changes in the market place based on performance on business and sales objectives by major geography. •Introducing solutions for a variety of marketing venues, such as web, PR, multi-media, direct-to-physician and direct-to-hospital TRAVEL REQUIREMENTS: •20-25% PHYSICAL DEMANDS/WORK ENVIRONMENT Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position requires significant travel to all international locations of St. Jude business interests outside of the US. |E-mail this position Submit Resume or C.V.2012-05-08 18:56:45United StatesSt. Jude MedicalMinnesotaID11733MNSt. Paul, MN28541761http://jobs.sjm.com/xml/28541761/jobUSAPlymouthGroup Lead - Production Job Requisition #: 13138 Date Posted: 05/07/2012 Category: Production Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview First shift position: (5AM - 2:30PM; M-F) Position Summary: Ensures the effective use of material, equipment and personnel in producing quality production; Responsible for ensuring inventory accuracy, cycle counts, and meeting build schedules; Essential Functions: • Manages directly the manufacture of medical device; • Ensures that quality and production goals are met; • Trains production operators on GMP, MP and retrain as needed; • Daily meeting with manufacturing operators for better communication and continuous improvement; • Organizes work schedule, Monitors performance and reports status; • Ensures PM (preventive maintenance) and Calibration stickers are up to date; • 5S audit and weekly meeting with other area value stream group-leads in a organization; and more; Qualifications: • Prefer two years of college or equivalent. • Prefer three - five years experience as a group-lead in a manufacturing environment. • Must be detail oriented, self-motivated, and have good communication skills. Must have the ability to read and interpret written documentation. Desired demonstrated knowledge of LEAN manufacturing, assembly, and production technical skills, and quality practices; • Computer skills desired in excel Microsoft word and have trained SAP (S2S) software • Ability to effectively work and communicate with others is critical. • Prefer pervious training experience in a manufacturing environment. • Six Sigma Green Belt Training |E-mail this position Submit Resume or C.V.2012-05-07 18:23:12United StatesSt. Jude MedicalMinnesota13138MNPlymouth, MN28478543http://jobs.sjm.com/xml/28478543/jobUSAAnn ArborField Clinical Engineer II Job Requisition #: 13010 Date Posted: 05/07/2012 Category: Field Engineer Location: Ann Arbor - MI - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working without appreciable supervision, is primarily responsible for demonstrated and consistent success in group leadership, FCE mentoring, project management, Clinical Research, publications in the technical/clinical literature, patent submissions, as well as consistently outstanding performance in: field support of Investigational Device Exemption (IDE)/Scientific Studies Organization (SSO) Clinical Trials, accurate technical support/ troubleshooting, strategic collaboration with Sales to develop business in the local territory and Field Input to various home office groups. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing calibration work. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Engineering, Biological Sciences, a related field, or equivalent. Typically a minimum of four years of relevant experience including at least two years as an FCE. Experience includes cardiology, electro-physiology, or working with implantable Implantable Cardiac Defibrillators (ICDs), pacemakers, or cardiac electro-physiology procedures. Broad cross-disciplinary and in-depth knowledge of the clinical engineering profession. A qualified record of implementing new processes to existing clinical engineering and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees, management, and customers. A comprehensive record of delivering research information which adds value to managements decision making process is required. A demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks is also required. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional Health Science certification or designation. |E-mail this position Submit Resume or C.V.2012-05-07 18:23:06United StatesSt. Jude MedicalMichigan13010MIAnn Arbor, MI28478479http://jobs.sjm.com/xml/28478479/jobUSADallasMetrologist III Job Requisition #: NMD3197 Date Posted: 05/07/2012 Category: Metrology Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Upgrade calibration equipment and automate repetitive calibration processes. Review/validate complex calibration procedures and software and establish new measurement standards. Provide regulation compliance recommendations for GMP, FDA, ISO 9000, ISO 13485, ISO 17025, ASTM, ANSI and NCSLI. Perform outside calibration supplier evaluation. Install and maintain equipment, scheduling and history databases. Assist in designing measurement systems for product test and process control. Perform complex multi-discipline electronic, electrical, dimensional and physical calibrations on all SJM measurement and process control equipment. Develop and write calibration procedures based on component specifications using spreadsheet, flow chart and word processing software and programming software. Review documentation, checklists and manuals for accuracy and completeness. Perform data analysis, measurement studies and calibration certifcate analysis. Participate in professional organizations and committees to set the standards and requirements for education, calibration and measurement assurance programs. Assist in designing measurement systems for product test and process control. Assist in day-to-day operations of the preventative maintenance (pm) program as needed. Major, On-Going Responsibilities: A. Lead Responsibilities • Coordinate daily activities of the site Metrology and PM group. Will serve as point of contact for daily requests for calibration and pm services and expedition of urgent calibrations. This includes prioritization and assignment of tasks to within the group as business needs dictated. • Perform root cause analysis on Out-of-Tolerance equipment and assign corrective actions as needed • Provide site specific monthly report input and analysis of metrics • Provide calibration planning on production line moves and transfers • Provide calibration startup and integration analysis, planning, implementation and support for acquisitions, new plants and remote product transfers B. Equipment calibrations/pm’s • Support all electronic and physical/mechanical calibrations • Research, evaluate and implement software and programs related to calibration measurement and management • Support measurement systems across division lines • Perform Inter-laboratory comparisons • Perform multi-discipline calibrations and complex measurement systems • Generate specification documents for outside calibration services • Plan training or calibration trips to off-site facilities • Travel by air to remote manufacturing sites to provide training and support (5% air travel) • Design calibration equipment and systems as required • Optimize the performance of the calibration equipment and systems • Select standards for complex/system calibration procedures based on tolerance accuracy ratios, specifications and measurement uncertainty • Complete assigned projects • Provide training sessions and perform presentations • Perform measurement uncertainty analysis • Review pm documentation for correctness and completeness C. Documentation • Write complex calibration procedures from component specifications • Perform programming verification related to procedure writing • Develop department procedures governing calibration tasks • Provide regulation compliance recommendations for GMP, FDA, ISO 9000, ISO 13485, ISO 17025, ASTM, ANSI and NCSLI • Research calibration standards, capital requests, and purchase requisition • Provide equipment control review • Handle preventative/corrective actions • Submit calibration and PM change orders • Review initial pm procedures for effectiveness D. Repair • Research complex repair situations and determine action steps • Perform analysis for repair prevention • Perform repairs, modifications and upgrade to calibration standards E. Administrative • Review system calibration procedures • Review out-of-tolerance reports • Use calibration data base systems including: history tracking and recall and overdue reports • Review computer software specific to metrology • Develop calibration tasks • Justify equipment expenditures for capital equipment requests • Perform interval and workload analysis • Perform interviews as needed • Research and evaluate calibration databases • Establish and implement statistical process control • Challenge and provide input to measurement standards • Design calibration lab layouts Qualifications: • High School degree required • 2 year technical degree required or equivalent military training • ASQ CCT recommended • 10+ years experience preferred • Previous experience in calibration and test methods on dimensioal, electrcial and physical equipment • Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements preferred • Knowledge of math operations, algebra, geometry, trigonometry and statistics and advanced Excel functions • Good communication and computer skills, including data analysis and report writing skills • Prior medical device experience preferred |E-mail this position Submit Resume or C.V.2012-05-07 18:22:27United StatesSt. Jude MedicalTexasNMD3197TXDallas, TX28478360http://jobs.sjm.com/xml/28478360/jobUSASylmarDirector, Regulatory Compliance and Patient Data Services Job Requisition #: CRMD42712 Date Posted: 05/07/2012 Category: Quality Assurance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working independently and in consultation with executive Quality Assurance management, has primary management responsibility directly or through lower management levels for the compliance of company facilities and related activities with applicable domestic and international regulations; works with U.S. Food & Drug Administration (FDA) and parallel agencies to address regulatory compliance activities and issues. Recommends, interprets, and implements corporate division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems; ensures employee compliance with such policies, practices, and procedures. Assures that quality of services meets internal and external customer requirements. Maintains a safe working environment and a strong customer focus. Exercises judgment in planning and organizing work; monitors performance and reports status. Sets goals, ensures that they are met and is responsible for continuous process improvement. Uses best business practices to ensure success in areas of responsibility. May be responsible for processes across organizational lines. Requirements/Education: A Bachelors Degree in physical/natural sciences, environmental engineering, or a related academic field. A minimum of at least ten plus years of progressively more responsible regulatory experience including experience with medical devices. Expert working knowledge of domestic and international regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices. A minimum of four plus years of demonstrated experience at a supervisory/managerial level is typical. Seasoned judgment acquired through wide experience and cross-organizational assignments. Ability to work cooperatively/productively with others. Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations. Requires highly developed leadership skills/people-management experience sufficient to assume the complex range of personnel issues inherent in this position. Must be adept at delegation, follow-up, and team building. Comprehensive verbal and written analytical/problem solving, communication, negotiation, interpersonal, training and presentation skills are essential. Documented record of delivering information that adds value to managements decision making process. Must have a demonstrated working knowledge of frequently used personal computer programs and applications used in relevant regulatory processes. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiac rhythm management technology. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc., are preferred. |E-mail this position Submit Resume or C.V.2012-05-07 18:22:22United StatesSt. Jude MedicalCaliforniaCRMD42712CASylmar, CA28478355http://jobs.sjm.com/xml/28478355/jobUSASt. PaulEngineer - R&D Job Requisition #: 12780 Date Posted: 04/02/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan. Essential Functions: • Run empirical and experimental analysis. • Demonstrated ability to conceptualize new devices using material knowledge and innovative mechanical design. • Conceive, build, and evaluate prototypes performance. • Work with outside consultants, vendors, and the medical community. • Project planning experience as well as the ability to identify and mitigate project risks • Support animal studies, bench testing, and clinical evaluations. • Support design reviews and physician visits. • Plan, coordinate, and execute activities to achieve project goals and objectives per established timelines. • Ability to conduct failure mode analysis and root cause investigation. • Demonstrated ability for part, device, and fixture design utilizing CAD tools. • Establish device requirements and specifications, including justification and supportive testing • Test method and model development • Maintains knowledge of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.). • Ensure compliance with procedural and documentation requirements of SJM, FDA and ISO design controls Technologies: • Biocompatible material selection for implants and del systems • Bioprosthetic implants • Mechanical design of biocompatible metals and plastics • NiTi Technonology • Machining • Molding • Extrusion • Packaging and Sterilization Other Duties: • Create product drawings and/or models • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • Bachelor's degree in Mechanical Engineering, Biomedical Engineering • 1-3 years experience • Experience with CAD tools required • Experience in designing and testing medical devices required • Experience employing experimental design & analysis tools preferred • Experience working with animal tissue preferred • Experience with a variety of manufacturing processes and designing for manufacturability preferred |E-mail this position Submit Resume or C.V.2012-05-06 19:03:55United StatesSt. Jude MedicalMinnesota12780MNSt. Paul, MN28470710http://jobs.sjm.com/xml/28470710/jobUSASylmarScientist, Staff Job Requisition #: 13133 Date Posted: 05/04/2012 Category: Research Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Works independently under broad supervision to provide strategic support in the design, construction, and testing of technology for implantable medical devices such as cardioverter defibrillators. Accountable for project ownership and management of new products from conception through qualification builds and into manufacturing. Identifies scientific problems and applies scientific principles to the solution of a broad range of complex problems. Conducts Research & Development (R&D) efforts involving theoretical and experimental study, conception and planning of clinical objectives and coordination and direction of clinical efforts. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing assigned technical work. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Continuously works towards work product/process improvement. Consults other departments in the field of technical expertise. Requirements/Education: Requires a Bachelors Degree in chemistry, physics, a related field, or equivalent. Typically a minimum of ten plus years research experience in cardiovascular medicine or related fields. Applies an extensive technical expertise and/or a thorough specialized knowledge at the forefront of the biomedical profession; applies, develops, and promotes advanced concepts and practices; required to perform as a recognized authority in the medical device profession. Requires the demonstrated ability to analyze and evaluate technologically complex devices; comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to work cooperatively and productively with others. Demonstrated ability to understand and comply with applicable U. S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet skills, word processing, data base management, and other relevant clinical applications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Demonstrated knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems is desired. |E-mail this position Submit Resume or C.V.2012-05-04 19:21:22United StatesSt. Jude MedicalCalifornia13133CASylmar, CA28440756http://jobs.sjm.com/xml/28440756/jobUSASt. PaulProgram Management Director Job Requisition #: AF13865 Date Posted: 05/04/2012 Category: Program Management Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Director of Program Management. The candidate will provide Program Management leadership to assure effective execution of complex medical device development projects through the Product Development Process (PDP). The candidate will lead activities to develop new medical products from initial concept through commercialization using the procedures of the Product Development Process. This position works cross-functionally and across Division entities as required with core team and functional managers to ensure that projects meet objectives and timelines. The candidate will also be developing metrics to assess the health of the development programs and work closely with the core team leads and functional managers to drive standard practices through the business. Impact this role will have within the AF division: • Manages strategic directions, product roadmaps, and portion of project portfolio. • Holds team members, functional management, and the organization accountable to tactical and strategic divisional objectives. • Meets with R&D engineering and marketing staff to clearly define product requirements. • Leads cross-functional development and deployment of a robust methodology for product development. • Facilitates the monthly program review board meeting including preparation and follow-up items. • Provides timely, accurate updates to management. • Trains, coaches, mentors, and evaluates team members and support group personnel to enhance the probability of successful project completion. Essential Functions: Leadership and Accountability: • Accountability for program management system effectiveness and execution. • Assists team leaders to define clear, realistic goals and direct projects utilizing the principles outlined by PMI’s PMBOK model of management. • Assures the timely development of program development planning. • Facilitates regular senior management oversight and evaluation of project status and progress. • Ensures that the cross functional members work as a team, focused on divisional goals. • Ensures effective communication channels between geographically separate divisional entities and Sales and Marketing organizations regarding project activities. Project Management: • Provides a general management understanding of the skills and tasks associated with all team functions to ensure proper and timely deployment of resources. • Directs and manages the core team members at necessary levels of detail required to accomplish project goals. • Synthesizes complex business and technical aspects of large scale development programs to develop an executable project plan. • Identify, develop, and execute detailed project plans to improve product development activities and business systems. • Works closely with Quality to ensure PDP compatibility and compliance with Quality Management Systems (QMS). • Applies the appropriate management techniques given project specific needs, risks and experience • Resolves project resource issues with core team members and functional managers to maintain project timelines. • Resolves conflicts within and outside the team to ensure project success. • Facilitates regular cross-functional input for core team member performance evaluations. Communication: • Ability to communicate effectively with all levels of the organization. • Ability to effectively develop and convey Project Management training materials. Facilitate cross-functional discussions on initiatives to improve PDP effectiveness. • Effectively develop and present to teams, functional managers, and senior staff project plans, needs, issues, mitigations, conclusions, and recommendations. • Ability to clarify options and facilitate issue resolution within project teams and within functional areas. • Ability to effectively make presentations to core teams, functional managers, senior staff, and external customers. Accountability/Supervision: Work is performed without appreciable direction. Determines organizational objectives and interprets company policies. Completed work is reviewed from a relatively long-term perspective for desired results. Initially accomplishes results directly. As business unit grows so may the opportunity for further development of this function resulting in work being increasingly accomplished through subordinate employees. Qualifications: • BA or BS with a major in math, engineering, life sciences, business, or other relevant degree required. • Minimum 10+ years of progressively responsible work experience in product development, project management, and project management supervision, in the medical device industry. • Formal training in Program/Project Management or a Project Management Professional Certification is required. • Proven track record of successfully managing cross functional projects to introduce new medical products globally. • Must have demonstrated written and verbal communication, interpersonal, and presentation skills. • Must be able to demonstrate successful leadership and organizational skills. • Must be able to operate effectively in matrix organizations. • Polished communicator - written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • An MBA or other related advanced degree is preferred. • Experience with software, capital equipment and sterile disposables desired. • Prior experience managing others strongly preferred. |E-mail this position Submit Resume or C.V.2012-05-04 19:21:16United StatesSt. Jude MedicalMinnesotaAF13865MNSt. Paul, MN28440745http://jobs.sjm.com/xml/28440745/jobUSAMinnetonkaMaterial Handler - 2nd Shift Job Requisition #: AF13862 Date Posted: 05/04/2012 Category: Materials Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Material Handler to coordinate and ensure timely and accurate flow of material, parts and assemblies to appropriate areas. This is a 2nd shift, Monday-Friday opportunity. Impact this role will have within the AF division: • aterial delivery -Deliver materials and parts to work areas according to specified standard work route -Maintain inventory by identifying, labeling, and placing materials and parts in stock; recording location of inventory; documenting units delivered and location of units -Perform appropriate transactions efficiently and accurately on computer -Maintain in-process inventory at work centers by delivering materials on a timely basis • Ensures accuracy of all material transfers, i.e., material issues to a work order, adjustments, transfers, miscellaneous issues • Investigate, identify and correct transactional and/or procedural problems related to inventory accuracy in coordination with buyers/planners, supervisors and/or information technology. • Performs housekeeping functions in area; properly maintains and stores tools and/or equipment. • Serve as a backup to stockroom operations. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. • Other duties as assigned. Required Qualifications: • High school diploma or equivalent • 1-2 years warehouse experience • Valid driver’s license • Requires attention to detail, successful track record of multitasking, and the ability to work in a fast paced environment • Forklift experience • Basic computer skills with Microsoft Office programs Preferred Qualifications: • Forklift certification • Experience with SAP |E-mail this position Submit Resume or C.V.2012-05-04 19:21:11United StatesSt. Jude MedicalMinnesotaAF13862MNMinnetonka, MN28440740http://jobs.sjm.com/xml/28440740/jobUSASt. PaulHardware Electronics Technician II Job Requisition #: AF13858 Date Posted: 05/04/2012 Category: Technician Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented Hardware Electronics Technician to participate on development projects within AF Product Development organization, focused specifically on St. Jude Medical electrophysiology equipment and its associated accessories. This individual will need to have hands on electronics experience, ability to troubleshoot electronics, and good documentation and organizational skills. Impact this role will have within the AF division: • Electro-mechanical and printed circuit board design, debug and assembly requiring soldering (SMT and through-hole), wiring, and mechanical fabrication. • Documentation and build of design verification devices • Provides design verification test support and test fixture design, documentation, and build. Must be able to follow and execute test protocols. • Write and release controlled documentation including test protocols, reports and design drawings. • Supports and will occasionally lead design and technical reviews. • Supports clinical evaluation of new products through equipment setup and coordination. • Communicates project status and issues/concerns to the appropriate management levels. • Identifies project risks. • Ensures compliance with procedural and documentation requirements of SJM, FDA and ISO design controls. Required Qualifications: • 5+ years’ experience in a technician role with medical devices experience or other highly regulated industry preferred • Minimum 2-year Associate’s degree in electronics is required. • Must be able to read and understand electrical schematics • Required experience operating various laboratory equipment such including the following: oscilloscope, power supply, multi-meter, and function generator. • Required soldering/wiring skills Preferred Qualifications: • Altium PCB design experience • Windchill Documentation system experience • Ability to effectively use Microsoft Products • Medical device experience preferred |E-mail this position Submit Resume or C.V.2012-05-04 19:20:47United StatesSt. Jude MedicalMinnesotaAF13858MNSt. Paul, MN28440724http://jobs.sjm.com/xml/28440724/jobUSASylmarClinical Data Coordinator II Job Requisition #: 13147 Date Posted: 05/04/2012 Category: Compliance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, is responsible for ensuring the integrity of clinical data both in the clinical database as well as in the clinical files. Responsible for entering, reviewing, verifying, modifying and organizing incoming clinical data. Identifies potential issues that could affect the quality of clinical data and forwarding to appropriate personnel. Provides administrative support for the clinical study as needed and for identifying solutions to continue to improve efficiency and quality in the data management process. Responsible for clarifying missing data with external customers. Exercises basic judgement in planning, organizing and performing work. Assures that quality of services meets internal and external customer requirements. This position will have primary responsibility for assigned studies with a basic knowledge of all studies managed by clinical data group. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of two years of demonstrated experience as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes. Experience with the Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to clinical data management and to the clinical trial process. Demonstrated competence in English spelling, grammar and punctuation, including the ability to successfully pass a reading comprehension pre-employment examination. Requires a demonstrated knowledge of the practices and procedures of the function, company products, polices and programs. Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously. Demonstrated interpersonal skills, including the ability to listen, resolve routine to moderately complex problems, deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators. Must possess demonstrated keyboard and personal computer skills (experience with Microsoft Office including Excel, Word or equivalent applications required), including the ability to pass a 10 key assessment examination. Desired Requirements: Associate Degree in a Computer Science, Health Science, a related curriculum, plus experience in the biotech, bio-instruments or medical devices industries. |E-mail this position Submit Resume or C.V.2012-05-04 19:20:16United StatesSt. Jude MedicalCalifornia13147CASylmar, CA28440701http://jobs.sjm.com/xml/28440701/jobUSASt. PaulTraining & Education Manager II Job Requisition #: AF13866 Date Posted: 05/04/2012 Category: Training Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a high caliber leader for the Manager of Training in our Atrial Fibrillation division (AFD). This additional manager position will allow more focus in enhancing the overall education strategy for customers as well as the global sales organization and will be a key member of the marketing team. The Manager of Training reports to the Senior Director of Product Education and Training. The Manager of Training is responsible for leading a team of subject matter experts who are focused on developing content for the global launch of AF products; deliver Train the Trainer programs in collaboration with the global selling divisions as well as to develop Education strategies to meet the needs of Associated Health Professionals. This position will work closely with the current Education Manager to oversee collaborative content development and cross-functional approaches to managing customer education. Essential Functions: ? Leads development of clinical and product training while closely collaborating with selling division(s) ? Leads and develops team of highly motivated individuals covering a broad product portfolio ranging from disposables to capital equipment ? Identifies the learning needs of various audiences and utilizes advanced knowledge to adapt the content and the delivery of the curriculum ? Coordinates numerous training projects aligning resources, setting timelines and milestones to maximize training effectiveness and efficiency ? Collaborates with R&D, Marketing and global sales force to ensure consistent and thorough messaging on all aspects of product training ? Actively manages and markets the AHP Education portfolio of offerings across key product lines ? Maintains and supports proficiency by keeping updated in current EP procedures and technologies Required Qualifications: ? Bachelor’s degree ? Experience in the field of EP – Sales, Clinical, Lab or related experience ? Familiarity with RF ablation systems, catheters and EP Mapping Systems ? Experience applying instructional design and adult learning strategies ? Management skills to access team performance and enhance development opportunities ? Strong interpersonal and communication skills to manage collaboration across departments ? High level strategic thought process to build on current program success ? Demonstrated Project Management skills. ? Evidence of leadership success in sales / training / sales support role ? Must be able to organize, initiate and provide educational programs for various audiences and skill levels. ? Expert level computer skills in MS Word, Excel and PowerPoint, as well as Adobe Acrobat applications. Preferred Qualifications: ? MS/MBA ? EnSite System experience |E-mail this position Submit Resume or C.V.2012-05-04 19:20:16United StatesSt. Jude MedicalMinnesotaAF13866MNSt. Paul, MN28440702http://jobs.sjm.com/xml/28440702/jobUSAPlymouthSenior Clinical Research Coordinator Job Requisition #: 13159 Date Posted: 05/04/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Senior Clinical Research Coordinator will implement and carry out functions of clinical research. Responsibilities: • Follow department Standard Operating Procedures • Assist with pre study evaluations • Initiate clinical investigations by arranging proctoring and staff training • In-house case report form auditing and data verification • Assist with regulatory reports (annual reports, progress reports) • Work independently on specific study projects • Assist CRA in setting up sites (IRB approvals, Investigator agreements, and study start up) • Assist with monitoring visits • Interact with study sites - Generate follow up reminder reports and send to investigators on a regular basis • Acquire professional, product and market expertise via independent reading, networking and training • Resource/train other clinical research coordinators • Travel approximately 10% • Participate in professional activities outside of normal business hours • Other duties as requested Requirements: One of the following: • High School Diploma with 4 years experience in an administrative role OR • BA/BS in Medical Science or Nursing or equivalent • 3 years experience in clinical research, preferably medical device company • Computer proficiency required: Word, Excel, Access, PowerPoint, internet, email • Ability to constructively interact with a range of personalities and positions inside and outside the organization • Attention to detail • Ability to organize, prioritize, and manage tasks in a changing environment • Ability to work independently and take direction from others |E-mail this position Submit Resume or C.V.2012-05-04 19:20:11United StatesSt. Jude MedicalMinnesota13159MNPlymouth, MN28440690http://jobs.sjm.com/xml/28440690/jobUSASylmarMachinist, Senior Job Requisition #: 12910 Date Posted: 05/04/2012 Category: Tachy Product Development Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Under limited supervision and in support of the manufacture of medical devices: constructs, maintains, calibrates, repairs, sets up and operates manual machine shop equipment; programs, sets up and operates Computer Numerical Control (CNC) equipment. Operates a variety of machine tools and works with designers and engineers to develop or modify tooling. Works from relatively complex blueprints, engineering specifications/diagrams and general engineering instructions to set-up and execute work assignments; checks work using precision inspection instruments and devices. Requirements/Education: High School diploma or equivalent. Typically a minimum of six or more years of relevant manual and CNC machining experience. Demonstrated knowledge and understanding of all aspects of the job, including the ability to set up and operate specialized and sophisticated machining equipment. Requires the demonstrated ability to read complex blueprints in order to determine the best method for manufacturing various components as well as the ability to use, operate, and apply a range of precision inspection instruments and devices, e.g., micrometers, calipers, height gages, etc. Demonstrated verbal and written communication, interpersonal, organizational and basic math skills. Must be able to perform functions utilizing machines and equipment requiring correctable vision, including color discrimination, and be able to demonstrate effective hand/eye coordination at an acceptable level of proficiency in all process certifications. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: AA degree in Mechanical Technology, equivalent trade school/military training, or comparable related experience in biomedical field. |E-mail this position Submit Resume or C.V.2012-05-04 19:20:09United StatesSt. Jude MedicalCalifornia12910CASylmar, CA28440687http://jobs.sjm.com/xml/28440687/jobUSASylmarBusiness Systems Analyst, Senior Job Requisition #: 12717 Date Posted: 05/04/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working without appreciable direction, provides ongoing application support to SJM CRMD users in order to solve business application related issues. This includes the training of system users in the different major business applications; works across CRMD to research and implement software applications that can improve business processes and in modifying current systems to accommodate changing business requirements. Identifies and routinely uses most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field of expertise. Requirements/Education: Bachelors degree in Information Systems, Computer Science or equivalent degree in a pertinent discipline required and 6 plus years of systems experience, including ERP, PDM, MES. Extensive knowledge of financial systems, financial analysis and sales analysis and reporting, ERP system applications , and/or Manufacturing / Engineering systems, and/or Patient Device Tracking systems and/or Device Master Record or Device History Record reporting systems. Must also possess the ability to understand, document , and enhance manufacturing business processes. Must be highly literate in terms of how mainframe, network and desktop systems operate. A relevant advanced degree is desired. Comprehensive verbal and written analytical/problem solving, communication, interpersonal and presentation skills required sufficient to conduct advanced discussions, interviews, negotiations, and give thorough presentations. Must be able to handle multiple projects simultaneously. Comprehensive personal computer skills including spreadsheet, word processing and data base management capabilities (including, but not limited to, such applications as Access, Excel and Word) are required. Team Center (Siemens-TCE) SQL Development Access Database Development .Net Development |E-mail this position Submit Resume or C.V.2012-05-04 19:19:57United StatesSt. Jude MedicalCalifornia12717CASylmar, CA28440683http://jobs.sjm.com/xml/28440683/jobUSASylmarAdministrative Assistant, Senior Job Requisition #: 13132 Date Posted: 05/03/2012 Category: Administrative Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under limited supervision, organizes, plans and performs a variety of secretarial, clerical, and administrative support duties, such as (but not limited to): receiving/screening/directing phone calls/faxes/e-mails; making travel arrangements; scheduling appointments; arranging meetings; preparing correspondence/reports/documents/presentations; collecting/distributing data; and maintaining paper/electronic filing systems. Takes initiative to improve work product and processes. May be accountable for reviewing work of less experienced employees for quality and content. Adapts existing work methods to different situations. Can resolve unusual, nonstandard problems; refers only significant deviations from approved policy/practice to supervisor or more senior level personnel for resolution. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of five or more years of progressively more responsible office clerical experience. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Incumbents are required to work cooperatively and productively with others. Demonstrated organizational skills, attentiveness to detail, and the ability to work under general supervision is required. Must be adept at handling multiple assignments in a timely manner while meeting assigned deadlines. Must also have demonstrated verbal and written communication, interpersonal, organizational and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: An Associates degree in Business Administration, a related field, or equivalent. Previous secretarial experience to department management. Experience in the biotech, bio-instruments, or medical devices industries are also preferred. Previous experience using Microsoft Outlook and the demonstrated ability to use Outlook Scheduler a plus. |E-mail this position Submit Resume or C.V.2012-05-03 20:20:57United StatesSt. Jude MedicalCalifornia13132CASylmar, CA28411520http://jobs.sjm.com/xml/28411520/jobUSAMinnetonkaSr. Manufacturing Eng. Technician Job Requisition #: AF13854 Date Posted: 05/03/2012 Category: Technician Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Senior Manufacturing Engineering Technician to join our Manufacturing Engineering (ME) team based in Minnetonka. This role will provide engineering technician support to a variety of projects led by Manufacturing Engineers in the ME group. This is a 1st shift, Monday-Friday opportunity with the flexibility to work overtime as needed. Impact this role will have within the AF division: • Participate in cross-functional teams to identify, analyze, and implement manufacturing improvements (e.g., processes, yields, and productivity). • Modify existing and design new tooling, fixtures and equipment to support departmental projects. • Develop and execute engineering builds to support process characterization and qualification studies via the completion of process and equipment IQ, OQ and PQ tasks. • Assist in writing technical reports by capturing experimental results, performing design of experiments (DOE), demonstrating technical writing skills and manufacturing documentation. • Summarize, analyze, and provide recommendations from test results. Required Qualifications: • Two year technical degree. • 7+ years of medical device industry experience. • Experience in GMP, ISO, and FDA controlled environments as demonstrated by experience in catheter assembly, equipment qualifications, and performing machine/ process set-ups. • Proficient computer, data analysis and report writing skills. Preferred Qualifications: • Experience in tooling and equipment design. • Experience with MS Windows, MS Office, and MS Project. • Intermediate experience working with Wildfire 4.0 or 5.0, Creo Elements/Pro (Pro/Engineer), Solidworks. • Understanding of American National Standards Institute (ANSI) and American Standards Mecahnical Engineers (ASME) and geometric dimension and tolerancing (GD&T) documentation standards. • Working knowledge of Windchill (PDM). • Working knowledge of statistical techniques, failure mode and effects analysis (FMEA), lean manufacturing and test method validations. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Energetic, organized, on-time, and a proven team and individual contributor. |E-mail this position Submit Resume or C.V.2012-05-03 20:19:58United StatesSt. Jude MedicalMinnesotaAF13854MNMinnetonka, MN28411507http://jobs.sjm.com/xml/28411507/jobUSAMinneapolisSenior Design Assurance Technician Job Requisition #: 13148 Date Posted: 05/03/2012 Category: Design Assurance Location: Minneapolis - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview The Senior Design Assurance Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. This position can be based in either Little Canada or Maple Grove but will involve travel between the two facilities. Essential Functions: • Monitor and/or perform calibration and maintenance of all test equipment and fixtures • Initiate documentation changes for test equipment, test methods, test protocols, and test reports. • Collect data, summarize, analyze, perform basic statistical analysis on, and document test results. • Assist with or perform Gage R&R studies. • Assist with the selection, installation and programming of precision measuring equipment. • Assist in designing, building, and evaluation of test methods and inspection fixturing, providing improvement recommendations. • Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations. • Support development, maintenance, and improvement of test labs and facilities. • Complete qualification of test equipment. • Train appropriate personnel on use of test equipment. Must be able to travel between Minnesota CVD sites, specifically St. Paul, Maple Grove, and Minnetonka. Qualifications: • High School degree required; 2 year technical degree preferred • 7+ years experience • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods • Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements including design controls • Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design • Training in blueprint reading and experience with sampling techniques • Good communication and computer skills, including data analysis and report writing skills • Prior medical device experience preferred • ASQ CQT certification or equivalent preferred • See Technician Leveling Chart for additional specific criteria |E-mail this position Submit Resume or C.V.2012-05-03 20:19:50United StatesSt. Jude MedicalMinnesota13148MNMinneapolis, MN28411501http://jobs.sjm.com/xml/28411501/jobUSASt. PaulSr. Hardware Assembler Job Requisition #: AF13850 Date Posted: 05/03/2012 Category: Assembly Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Senior Hardware Assembler. The successful candidate will be working directly with the assembly of high-tech cardiovascular medical devices. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 1st shift (7a.m.-3:30p.m.), Monday-Friday opportunity. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Coordinates assigned jobs and activities, while including mentoring and cross training others on operation functions. • Train employees on processes (new processes and process changes). • Perform workstation, cell and/or machine setup, test and perform rework procedures. • Understands and accurately completes necessary paperwork. • Other duties as assigned, such as: including scheduling, updating metric boards, providing backup for the Supervisor. Required Qualifications: • High school diploma or equivalent. • 5+ years of hardware and/or electronics assembly experience. • 2+ years of medical device industry assembly experience. • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Strong written and verbal communication skills. • Demonstrated ability to communicate and interact with others including, but not limited to Supervisors and Engineers. • Must be computer proficient. • Ability to trouble shoot and problem solve. • Understand lean principle concepts (CCDS – Certified Cardiac Device Specialist, 5S, Kaizen), and has the ability to identify and continually make suggestions for process improvements. • Must have a high level of attention to detail. • Demonstrated consistent attainment of established cycle times for all process steps within primary work cell. • Demonstrates a high sense of leadership and ownership in primary work cell. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time and detailed. • Energized attitude. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-03 20:19:35United StatesSt. Jude MedicalMinnesotaAF13850MNSt. Paul, MN28411498http://jobs.sjm.com/xml/28411498/jobUSADallasEngineering Technician II Job Requisition #: NMD3195 Date Posted: 05/02/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working under limited supervision, lays out, builds, tests, troubleshoots, repairs and modifies assemblies, components, and parts of developmental and production product items. Takes initiative to improve work product and processes. Performs relatively complex assignments and solves problems that may have a variety of solutions. Adapts work methods to different situations. Can resolve unusual, nonstandard problems. May serve as lead and assign work to less experienced personnel; review work of lower-level employees for quality and content; serves as a mentor when assisting less-experienced lab staff in solving more complex problems. Major, On-Going Responsibilities: Essential Functions: • Builds prototype, engineering, validation, and qualification units for development of new products and processes. Discusses layout and assembly procedures and problems with engineers and draws sketches to clarify design details and functional criteria of product units. Assembles experimental assemblies or complete prototype model. Recommends changes in components or installation specifications to simplify assembly and maintenance. • Participates in and supports the establishment of test validation plans. • Sets up standard test apparatus or devises test equipment and circuitry to conduct functional, operational, environmental, and life tests to evaluate performance and reliability of prototype or production units. • Interprets test data, analyzes product performance, develops summaries, and assists in the initiation of yield improvements. • Instructs production personnel in the manufacturing and testing of product devices. • Assists engineers in the troubleshooting of failed product and production lines. Other Functions and Duties: • Supports maintenance activities on designated production equipment. • Assists with and participates in the development of work instructions, technical descriptions for manufacturing, and test operations. • As directed by engineers, provides technical support to production lines. • Performs related duties, on occasion, as assigned or required. Accountability/Supervision: Working under limited supervision, is responsible and accountable for ensuring that production areas are supported as related to test and product performance issues. Working under minimal supervision, is accountable for analytical failure analysis and reporting to ensure identification and correction of function problems and errors.. Does not require instructions for routine assignments; requires some general instructions (written and verbal) for new or special assignments. Errors will have impact on the department. Works is reviewed in progress for soundness of judgment and overall adequacy/accuracy. Uses fundamental technical concepts and practices to sort out information logically, and distinguishes between fact and opinion. Takes initiative to improve work product and processes. May be accountable for reviewing work of less-experienced employees for quality and content. Performs relatively complex assignments and solves problems that may have a variety of solutions. Adapts work methods to different situations. Can resolve unusual, nonstandard problems. Minimum Educational, Experience or Other Qualifications: • High school diploma or equivalent, and trade school certification, specialized training/apprenticeship and/or equivalent in Electronics, Engineering Technology, or specialized training which provides a theoretical understanding of electronic or electro-mechanical disciplines or equivalent. • Typically a minimum of eight or more years of progressively more responsible related work experience required to achieve the level of competency and depth of understanding necessary to perform at this level. • Incumbents are required to work cooperatively and productively with others. • Demonstrated organizational skills, attentiveness to detail, and the ability to work under limited supervision is required. • Must be adept at handling multiple assignments in a timely manner while meeting assigned deadlines. • Demonstrated eye-hand coordination and the demonstrated hands-on fabrication and test skills, the capability to work with small precision devices, a working knowledge of the manufacturing and test equipment required, and the ability to work independently under limited daily supervision. • Must also have demonstrated verbal and written communication, interpersonal, organizational and basic math skills. • The comprehensive ability to read, write, communicate effectively in English, converse in technical terminology, and perform a range of mathematical calculations and measurements is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. • The ability to successfully pass a reading comprehension pre-employment examination is mandatory. • The demonstrated ability to understand and comply with applicable Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. • Must have demonstrated personal computer application skills (e.g. spreadsheet and word-processing). • Must be able to maintain regular and predictable attendance; the ability to work overtime is also required. • Must have the ability to on occasion lift up to approximately fifty pounds. Preferred Qualifications: • Associates degree in Engineering Technology or other relevant discipline. • Technical ingenuity and creativity to support and assist with design work. Relationships: Internal: Routine contact with supervisor and engineers that are being supported. May work with and lead lower level employees. Collaborates with other teams within the department, other departments for requirements, and other sites as necessary. May serve as lead for less experienced employees. May also be part of a project team where frequent exchange of information is required; participates as team member; contributes to achieving team goals. External: May have contact with vendors or customers at other facilities to support the development or improvement of a product or process. Equipment: Works with most or all of the manufacturing and quality tools for the product supported. Works with test/analytic equipment utilized in the development of new products. Utilizes a microscope. Uses a personal computer and standard office equipment, e.g., telephone, copier, fax machine, etc. Working conditions: Work is normally performed in a laboratory environment and in a manufacturing clean room. May work with chemicals to clean and process the product. Some work may need to be performed in a fume hood. Physical Demands: Activities require a significant amount of sitting, walking and standing relative to interaction with other Company personnel and while standing at test benches and related laboratory stations. Significant use of hands and arms, plus finger dexterity to reach, hold, and manipulate laboratory equipment, tools and machines, and objects under study and development. Significant use of voice and hearing for discussions with engineers, other technicians and related. Requires clear vision (correctable) and excellent hand-eye coordination. Exerts negligible force to move objects. May be required to lift equipment weighing up to approximately fifty pounds and placing it in a storage rack or on test stations. |E-mail this position Submit Resume or C.V.2012-05-02 18:55:33United StatesSt. Jude MedicalTexasNMD3195TXDallas, TX28333036http://jobs.sjm.com/xml/28333036/jobUSADallasContinuous Improvement Engineer Job Requisition #: NMD3194 Date Posted: 05/02/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Organizes, plans, facilitates, and participates in key Continuous Improvement (CI) projects and initiatives. Major, On-Going Responsibilities: Essential Functions: • Organizes, plans, facilitates, and participates in key Continuous Improvement (CI) projects and initiatives. • Identifies improvement project opportunities across the organization which could benefit from the utilization of Lean and Six Sigma tools. These tools may include, but are not limited to: Value Analysis, Structured Problem solving approach, and Pareto principle. • Contributes to and may initiate the planning, organizing, performing, coordinating project tasks, and activities • Actively provides support to the CI certification process, Excellence Reviews, and other CI related activities as directed • Supports multiple projects/teams as necessary, ensuring that projects are completed on time while utilizing project management tools and techniques • Provides support to other CI Team members on key breakthrough projects and initiatives • Designs workstations to ensure ergonomics and optimize efficiencies and standard operations • Develops and/or delivers Lean Visual Management and Problem Solving training Other Functions and Duties: Supports all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision: Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy. Experience and Training: • BS in Industrial Engineering or related field • 3+ years demonstrated experience in implementing Lean Production System and Cellular Manufacturing using Kaizen (DMAIC) methodology • Six Sigma Green Belt certified or equivalent demonstrated experience required • Experience working in a cross-functional team environment • Microsoft Office and Microsoft Project proficiency is highly desired Preferred Qualifications: Medical Device experience, specifically active implantables. Relationships: Internal: Primarily internal company contacts. External: Infrequent inter-organizational and outside customer contacts on routine matters. Equipment: Utilizes a personal computer and a variety of standard office equipment including telephone, copier, fax, etc. Work Environment: Works primarily in a standard office environment with air conditioning, good lighting, and moderate noise level. May also visit controlled-environment production area, research labs, testing labs, production and other areas as well as vendor facilities as necessary. Physical Demands: Activities require a significant amount of sitting, some standing and walking, and, on occasion, travel. Relatively light effort lifting and handling product items, office supplies, and using standard office equipment. Other Skills/Characteristics: • Skilled verbal and written communicator • Goal/results oriented • Aibility to work independently • Ability to work under pressure and with short deadlines • Ability to multi task various functions and skill sets • Good organizational skills and attention to details |E-mail this position Submit Resume or C.V.2012-05-02 18:55:28United StatesSt. Jude MedicalTexasNMD3194TXDallas, TX28333033http://jobs.sjm.com/xml/28333033/jobUSASylmarCo-op Job Requisition #: 13022 Date Posted: 05/02/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview The Co-op (i.e., Co-operative Education”) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the student’s university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses’ fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. 1) Good communication and teamwork skills for working with all levels of employment and outside vendors 2) Needs to know the basics of Word, Excel, and PowerPoint 3) Familiar with computer aid software such as Pro-engineering and Windchill 4) Knowledge of drafting techniques and tool design 5) Familiar with product life cycle programs (Teamcenter) 6) Proactive and willing to learn new things; Not afraid of new challenges 7) Ability to multi-task and switch to higher priority tasks with little notice |E-mail this position Submit Resume or C.V.2012-05-02 18:55:02United StatesSt. Jude MedicalCalifornia13022CASylmar, CA28333006http://jobs.sjm.com/xml/28333006/jobUSADallasSr. Quality Systems Engineer Job Requisition #: NMD3196 Date Posted: 05/02/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working without appreciable supervision. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Provides quality system engineering support to site functions to ensure sub-system implementation complies with the NMD quality system requirements and governing regulations. This includes ensuring that system changes do not have an adverse effect on other sub-systems abilities to meet their requirements. Provide project management duties of quality system improvement projects. Major, On-Going Responsibilities: • Collaborate with cross functional management teams to define or improve quality system processes • Determine if organizational units are performing their defined processes and procedures in compliance with the NMD quality system and governing regulations, document deficient conditions • Act as Lead to plan, report on, follow-up and close scheduled and unscheduled quality system projects. • Obtain and analyze objective evidence as a basis for preparing an informed, objective report on the compliance of the process, discuss deficiencies and recommend corrective action, as requested. • Evaluate, or assist in evaluating, the adequacy of the corrective action to improve deficient conditions. • Perform or assists in the performance of special reviews as requested Experience and Training: • Bachelors degree Quality Engineering or related discipline • 5-8 years of experience with quality systems engineering in a regulated (FDA) industry. • Knowledge of FDA CFR part 820, ISO 13485:2003, CMDCAS, AIMD • Project Management experience a plus • Excellent communication skills, including written, verbal and interpersonal • Excellent organization and administrative skills • Ability to work independently with minimal supervision • Takes initiative to perform tasks that benefit the organization Other Skills/Characteristics: Equipment: Computer keyboard; standard office equipment Working Conditions: Normal office environment |E-mail this position Submit Resume or C.V.2012-05-02 18:54:00United StatesSt. Jude MedicalTexasNMD3196TXDallas, TX28332987http://jobs.sjm.com/xml/28332987/jobUSASylmarEngineer II, Design Assurance Job Requisition #: 13072 Date Posted: 05/02/2012 Category: Quality Assurance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, prepares and coordinates the qualification testing of potential new products, accessories and components. Provides training to Quality Control Engineers and Inspectors, and to Manufacturing Engineers for the transference of the product into production. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: A Bachelor of Science Degree in Mechanical Engineering or in a physical science, a related field, or equivalent. Typically a minimum of three plus years of progressively more responsible work experience in a high technology manufacturing environment. Broad technical knowledge of the design assurance profession knowledge; expertise in one or more relevant specialties. Familiarity with commodity and off-the-shelf electronic components. Basic familiarity with industry-wide standards for qualifying components and sub-assemblies. Demonstrated experience in the use of common laboratory-type equipment. Demonstrated verbal and written analytical/problem solving, communication, interpersonal and presentation skills. Ability to work well with others in various disciplines and at various sites. Demonstrated personal computer skills including spreadsheet, word processing, and data base management capabilities. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Experience in a regulated medical industry. |E-mail this position Submit Resume or C.V.2012-05-02 18:53:59United StatesSt. Jude MedicalCalifornia13072CASylmar, CA28332985http://jobs.sjm.com/xml/28332985/jobUSASylmarManager, Senior Product Marketing Job Requisition #: 12263 Date Posted: 05/01/2012 Category: Marketing Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Acting independently and within broad policy, has primary management responsibility for developing comprehensive and integrated portfolio and commercial strategies within core CRM markets and product segments. Responsible for early phase product planning activities including business justification, executing and managing implementation of commercial strategies and development and execution of product commercialization plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible experience in a Marketing capacity, with focus on strategic product planning and commercial execution. Requires highly developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential; Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2012-05-02 18:53:58United StatesSt. Jude MedicalCalifornia12263CASylmar, CA28332984http://jobs.sjm.com/xml/28332984/jobUSASt. PaulAnalyst, Product Surveillance Job Requisition #: 13012 Date Posted: 05/01/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Overview: The Product Surveillance Analyst is responsible for performing evaluations of returned St. Jude Medical Cardiovascular Division products, including heart valves and valve repair products, and other CVD products as requested. The Analyst coordinates product testing/analysis with other CVD departments and external consultants, prepares technical reports of findings and customer letters, operates and maintains the Product Surveillance Laboratory and equipment, and collects and evaluates analysis information. The PS Analyst monitors product performance as it relates to the evaluation of products and is key in identifying potential areas of concern. Responsibilities: • Records condition of returned products including observations, photographs • Coordinates product testing/analysis with other CVD departments and external consultants • Prepares technical reports of analysis/findings • Records evaluation/testing information within the complaint database, as appropriate • Collaborates with cross-functional groups (e.g. Quality Engineers, R&D) on evaluation trends or findings and participates in complaint review groups and risk management activities, as requested • References technical product specifications, Device History Records, or measurements obtained • Utilizes safe biohazard and chemical handling practices at all times • Is diligent in observing for any unusual trends in product complaints • Archives complaint records or returned products & retrieves information on previous investigations • Supports complaint database upgrades and conversions by providing input and performing system testing • Ensures accurate department procedures and work instructions are maintained • Support inspections by external regulatory agencies (e.g. FDA, Notified Body) as requested Requirements: • Four-year degree in science or technical field, or two-year degree and relevant experience supporting product analysis or complaint handling investigations • Solid written and verbal communication skills • Able to work independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously • Strong problem-solving skills • Strong computer skills Preferred Qualifications: • Medical terminology • Anatomy and physiology • Experience with various lab equipment (e.g. microscopic photography, biological cabinet) • Experience handling biohazard specimens and knowledge of universal precautions Report Comments |E-mail this position Submit Resume or C.V.2012-05-01 19:15:45United StatesSt. Jude MedicalMinnesota13012MNSt. Paul, MN28305216http://jobs.sjm.com/xml/28305216/jobUSAMinnetonkaSenior Engineer - Quality Job Requisition #: 13093 Date Posted: 05/01/2012 Category: Engineering Quality Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: Senior Supplier Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Cardiovascular Division and regulatory requirements. Primary responsibility is for plastics commodities. Duties and responsibilities: • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits. • Manages development of supplied product inspection procedures and first article requirements. • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions. • Contributes to the development, maintenance and improvement of CVD supplier quality program policies, procedures and forms. • Evaluates and develops Supplied Data Agreement partnerships with suppliers. • Provides engineering guidance to CVD Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures. • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies. • Reviews and approves all supplied product drawings and component quality plans. • Works with Manufacturing engineering to assess and address purchased product issues. • Provides project direction, coaching, and mentoring for technical team personnel. • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements. • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews. • Contributes and participates in supplier performance reviews. • Participate in or lead teams in supporting Supplier Assurance program requirements (e.g., represent the Supplier Assurance function as a Core Team Member) • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement Minimum Qualifications: • BS degree in Engineering or Technical Field • 5+ years experience preferred • Previous Supplier Quality engineering experience and demonstrated use of Quality tools/methodologies. • Prior medical device experience preferred with detailed knowledge of FDA and ISO 13485 regulations • Plastics commodity expertise preferred (injection molding and extrusion) • Advanced computer skills, including statistical/data analysis and report writing skills • ASQ CQE and CQA certification preferred |E-mail this position Submit Resume or C.V.2012-05-01 19:14:54United StatesSt. Jude MedicalMinnesota13093MNMinnetonka, MN28305043http://jobs.sjm.com/xml/28305043/jobUSAIrvineQuality Control Inspector Job Requisition #: AF13852 Date Posted: 05/01/2012 Category: Quality Control Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Quality Control Inspector. The successful candidate in this position will perform a wide variety of functions, including visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures and be able to utilizing measuring equipment and procedures. Impact this role will have within the AF division: • Perform visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures. • Work closely and cooperatively with area Supervisor or Quality Engineer to ensure quality checkpoints are in place as part of the production process and partner with quality work groups on day-to-day problem solving related to product production and process improvement. • Communicate with Quality/Manufacturing Engineering and Management on quality issues. • Practice Good Manufacturing Practices (GMPs) including documentation practices and proper gowning techniques. • Review device history records for sign-off of completion of operation and accuracy. • When applicable, initiate and complete nonconforming material reports to ensure appropriate disposition of nonconforming material. • Provide and complete required GMP, Issue resolution and task specific training. • Assist in the implementation of changes required. • Support quality inspection functions of other manufacturing cell product lines as needed. Required Qualifications: • High School diploma • Prior experience with Quality Control in a manufacturing environment. • Execute test protocols, final inspection testing under engineer supervision. • Be able to communicate ideas effectively both verbally and in writing and to facilitate change. • Working knowledge of Good Manufacturing Practices (GMPs). • Excellent interpersonal and communication skills are essential for success. • Must be able to work well with others in a team environment and have a hands-on approach to problem solving. • Must possess the ability to handle multiple tasks with attention to detail. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience in an Inspector role. • Prior experience in the medical device industry. |E-mail this position Submit Resume or C.V.2012-05-01 19:14:51United StatesSt. Jude MedicalCaliforniaAF13852CAIrvine, CA28305015http://jobs.sjm.com/xml/28305015/jobUSAWestfordGroup Lead - Production Job Requisition #: 12937 Date Posted: 04/30/2012 Category: Assembly Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Ensures the effective use of material, equipment and personnel in producing quality production; Responsible for ensuring inventory accuracy, cycle counts, and meeting build schedules; Essential Functions: • Manages directly the manufacture of medical device; • Ensures that quality and production goals are met; • Trains production operators on GMP, MP and retrain as needed; • Daily meeting with manufacturing operators for better communication and continuous improvement; • Organizes work schedule, Monitors performance and reports status; • Ensures PM (preventive maintenance) and Calibration stickers are up to date; • 5S audit and weekly meeting with other area value stream group-leads in a organization Other Duties: • BBSP Observation • Help with any employee needs; ( assist with training and employee ESS needs) • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • Prefer two years of college or equivalent experience. • Prefer one - three years experience as a group-lead in a manufacturing environment. • Must be detail oriented, self-motivated, and have good communication skills. Must have the ability to read and interpret written documentation. Desired demonstrated knowledge of LEAN manufacturing, assembly, and production technical skills, and quality practices; • Computer skills desired in excel Microsoft word and have trained SAP (S2S) software • Ability to effectively work and communicate with others is critical. • Prefer pervious training experience in a manufacturing environment. |E-mail this position Submit Resume or C.V.2012-04-30 18:49:16United StatesSt. Jude MedicalMassachusetts12937MAWestford, MA28273661http://jobs.sjm.com/xml/28273661/jobUSAMaple GroveSenior Packaging Engineer Job Requisition #: 13117 Date Posted: 04/30/2012 Category: Engineering Location: Maple Grove - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Maple Grove. Job Overview Position Summary: Support packaging and labeling processes for established product lines. Develop packaging and labeling for new products. Essential Functions: •Select, procure, install, and validate packaging and labeling equipment •Conduct Process FMEAs •Identify and implement packaging/labeling process improvement projects •Design, develop and test a wide variety of packaging used for the protection, display, and handling of products. •Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering •Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques •Responsibilities include documentation management and an understanding of Good •Manufacturing Practices (GMPs) •Creation and management of change requests within the document control system (currently Windchill) Qualifications: •Packaging Engineering or Mechanical Engineering degree •5+ years experience in packaging or material handling •Medical device experience required •Understanding of FDA, GMP, and ISO guidelines •Experience with equipment process validation principles as well as engineering documentation practices and statistical process control •Requires ability to be innovative, resourceful, and work with minimal direction •Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams |E-mail this position Submit Resume or C.V.2012-04-30 18:47:48United StatesSt. Jude MedicalMinnesota13117MNMaple Grove, MN28273621http://jobs.sjm.com/xml/28273621/jobUSASt. PaulSr. Verification & Validation Engineer Job Requisition #: AF13851 Date Posted: 04/30/2012 Category: Software Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented software engineer to join our Software Verification and Validation team. The Senior Software V&V Engineer will bring a testing expertise to the Verification and Validation of the EnSite system. This high caliber individual will have significant into the day-to-day impact of defects, workflow, and the EnSite application. Responsibilities include requirements analysis, test design, test execution, defect issue resolution, and support of the engineering team’s investigation of field complaints. Impact this role will have within the AF division: • Work independently and as a team member to plan, write, and execute test cases according to St Jude Medical practices, FDA regulatory, and ISO standard procedures. • Participate in the requirements, hazard analysis, and design reviews for new features. • Evaluate, recommend, and employ software tests tools to ensure software quality. • Designs new test suites for new features and functionality. • Provides verification and validation perspective to R&D’s ongoing product development: requirements, product and test designs, defect reviews, user workflows, and field complaint investigations. • Display initiative, leadership and coaching skills in continuous quality and engineering process improvement. • Maintains expert status and continuing proficiency in the field of software test engineering. Required Qualifications: • Bachelors degree in computer science or equivalent. • 7+ years of professional software test engineering experience. • 2+ years of FDA regulated industry experience. • Experience with software development lifecycle management tools. • Experience with Windows and LINUX operating systems. • Strong technical skill set, including spreadsheet, word processing, PowerPoint and specialized applications. • Excellent documentation skills in delivering information that adds value to managements decision making process. • Experienced in quantitative, analytical, organizational, and follow-up skills. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Masters degree • Current industry knowledge of electrophysiology and/or cardiac rhythm management products. • Experience with C++, Perl, and Python programming languages. |E-mail this position Submit Resume or C.V.2012-04-30 18:47:03United StatesSt. Jude MedicalMinnesotaAF13851MNSt. Paul, MN28273584http://jobs.sjm.com/xml/28273584/jobUSASylmarManager, Software Development Job Requisition #: PR8006A Date Posted: 04/27/2012 Category: Software Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Software Engineering Manager. Lead team of engineers in the testing of applications software for use in cardiac pacing and associated medical systems products, including responsibility for senior-level engineering services involving the specification, implementation and testing of software incorporating graphical user interface designs, embedded real-time applications, test and simulation features, and device subsystems requirements; the formulation of test strategies; the creation of test design documents; the implementation and execution of manual, interactive and automated test processes; the initiation of value-added process improvements for software verification procedures; the direction of verification, validation, configuration management and defect tracking activities; and the use of requirements software tools (including ClearCase, ClearQuest and DOORS), as well as Java- based programs, Visual Studio and graphical user interface (GUI) applications. Either U.S. or foreign Master’s degree in computer engineering or management, and 1 year of experience in the occupation or in a software developer, programmer, programmer trainee or related capacity; or U.S. or foreign Bachelor’s degree in computer engineering or management, and 5 years of progressively responsible experience in the occupation or in a software developer, programmer analyst, programmer trainee or related capacity. |E-mail this position Submit Resume or C.V.2012-04-27 19:58:25United StatesSt. Jude MedicalCaliforniaPR8006ACASylmar, CA28240313http://jobs.sjm.com/xml/28240313/jobUSADallasEngineering Tech Job Requisition #: NMD3192 Date Posted: 04/27/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Assist with PCB design & layout, electrical design support, manufacturing documentation support for design, development and characterization of engineering prototypes and evaluation boards. Preforms various product tests and write reports as required. Analyzes products using appropriate test equipment, schematics and associated documents. Position would require interface with Manufacturing, Quality and other cross functional groups as necessary. Major, On-Going Responsibilities: • Capture multi-layer, mixed signal PCB designs and packaging of electronic designs per the applicable product design, development and release procedures, and guidelines. Support CAE/CAD component librarians as necessary. • Capture circuit schematics and design PCB layouts per the applicable product design, development and release procedures, and guidelines. • Capture mechanical part and assembly level drawings using a CAD tool • Support R&D, systems integration and systems testing operations by building mechanical assemblies per product drawings, assembling, testing and troubleshooting electronic circuit boards under engineer's supervision and per applicable procedure and guidelines. • Support engineering by assisting in the purchasing of components and equipment Experience & Training: • Associate’s Degree in Electronics or related experience. • Minimum 2-3 years experience in electronics or computer field. Must have basic knowledge of analog and digital electronics theory. Excellent troubleshooting skills. • Knowledge of test equipment such as oscilloscopes, multimeters, function generators, frequency counters, and logic analyzers. CAD experience for PCB or IC development desired. • Medical device experience valued. • Good manual dexterity; able to solder or probe delicate electronic circuits. Must possess good verbal and written English skills. Strong mechanical /machining skills a plus. |E-mail this position Submit Resume or C.V.2012-04-27 19:58:17United StatesSt. Jude MedicalTexasNMD3192TXDallas, TX28240312http://jobs.sjm.com/xml/28240312/jobUSADallasStaff Accountant Job Requisition #: NMD3193 Date Posted: 04/27/2012 Category: Finance Accounting Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working under general supervision and acting as the subject matter expert, responsible for the control and accountability of fixed assets. Assists in month end close, performs variance analysis of general ledger accounts, performs reconciliation of balance sheet accounts, and may also participate in ad hoc accounting projects. Exercises judgment in planning, organizing and performing work. Interacts with various levels of the organization, providing support and guidance in the area of fixed assets. Major, On-Going Responsibilities: • Coordinates the capital expenditure approval process. Including review of cost benefit analysis and appropriateness of assumptions made. Provides guidance to requestor where needed. • Performs fixed asset creation & maintenance, to include additions, transfers, and disposals, determination of asset class, cost center, and useful life. This requires an in-depth understanding of the SAP fixed asset module, as well as the application of business judgment based upon an understanding of the company’s business structure and objectives. • Utilizes internal order reporting to monitor capital spend vs. Plan, providing monthly reporting for cost center owners. • Performs & validates monthly depreciation runs. • Performs physical inventory of fixed assets at prescribed intervals. • Assists in month end close, to include journal entry preparation & account analysis. • Performs review/analysis of operating expenses including adjustments and reclassifications. • Performs reconciliation of balance sheet accounts. • Performs vendor master creation and maintenance. • Preparation of ad-hoc reports & analysis upon request. Experience & Training: • Bachelors Degree in Accounting, Finance, or related field. • 1-3 years general accounting experience. • Knowledge & understanding of accounting and GAAP. • Experience with ERP systems, SAP preferred. • Proficiency with Microsoft Office, most notably Excel, Word, & Outlook. • Strong analytical skills, with attention to detail. • Strong verbal & written communication skills. • Ability to multitask. • Strong interpersonal skills and the ability to work in a team environment. |E-mail this position Submit Resume or C.V.2012-04-27 19:58:15United StatesSt. Jude MedicalTexasNMD3193TXDallas, TX28240311http://jobs.sjm.com/xml/28240311/jobUSAMinnetonkaEngineer - Process Development Job Requisition #: 13116 Date Posted: 04/27/2012 Category: Process Development Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: This position will design and develop manufacturing processes, tooling, and fixtures to support catheter based new product development and improve established production processes while enhancing productivity and product quality. Essential Functions: • Develop and implement new process and improvements • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment • Work with Product Development to ensure Design for Manufacturability • Provide technical mentorship to engineers and technicians • Conduct Process FMEAs and Process Validations • Interface with vendors for incoming components • Utilize tools like Gage R&R, DOE, Cp, Cpk, and SPC to improve processes • Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. • Generate and modify manufacturing process documentation Individual should: • Be innovative, resourceful, and work with minimal direction • Have excellent organization, problem solving, communication, and team leadership skills • Work effectively with cross-functional teams Education and/or Experience: • Mechanical Engineering degree required • 3+ years related experience • Medical device experience preferred • Strong analytical, problem solving and project management skills • Demonstrated leadership capability in team settings • Six Sigma certification preferred |E-mail this position Submit Resume or C.V.2012-04-27 19:57:38United StatesSt. Jude MedicalMinnesota13116MNMinnetonka, MN28240286http://jobs.sjm.com/xml/28240286/jobUSASt. PaulLabeling & Technical Publ Manager II Job Requisition #: AF13855 Date Posted: 04/27/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Labeling and Technical Publications Manager II to join our organization. Within this role, the primary responsibility is to manage department activities and personnel at one or more sites chartered with managing the creation and maintenance of product and component labels, instructions for use, and other product documentation that comply with regulatory, company, and division requirements. This includes implementing and monitoring associated processes, systems, and equipment. This position provides work direction, performance management, and support to direct reports, administers policies and procedures, and interacts with other managers and functional peers throughout the company at various management levels to ensure processes are efficient, effective, and compliant. Impact this role will have within the AF division: • Direct/prioritize department and/or team activities through direct supervision of coordinators, specialists, engineers, technical writers, contractors, and/or team leaders and their team members. • Lead strategic and/or complex tactical initiatives of short to long duration, moderate to high complexity, and/or multi-function, multi-site, or global scope. • Establish best practices by application of experience, benchmarking, networking, and continuous learning. • Ensure organization business value through understanding of customer needs, business objectives, regulatory requirements, and continuous improvement opportunities. • Manage employee and organization performance and development through objectives alignment with business goals, coaching, mentoring, and metrics. Required Qualifications: • Bachelor’s degree in Engineering, Life Sciences, Business, or other relevant field. • 3+ years supervisory and/or project management experience. • 5+ years medical device experience working with product labeling, packaging, and/or global regulatory requirements. • Effective organizational skills, ability to coordinate multiple tasks, manage priorities and yet exhibit critical detail orientation. • Excellent communication skills as recognized by team members and management. • Ability to bridge communication between technical and business areas for a full and complete understanding of expectations. • Demonstrated project management skills, able to handle complex tasks with little or no direction • Excellent reputation for building cross-functional relationships and groups. • Energized attitude to drive effective results, as recognized by peers and project team customers. • Strong understanding of FDA and ISO quality system requirements • Excellent logical, analytical, and problem solving skills • Skilled user of MS Word, MS Excel and MS PowerPoint • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Skilled user of labeling • ERP (SAP preferred) • PDM (Windchill preferred) systems • Experience implementing content management systems such as Arbortext • Experience with projects involving international stakeholders • Certification or advanced degree in Project Management, Technical Communications, Packaging, or Regulatory Affairs |E-mail this position Submit Resume or C.V.2012-04-27 19:57:04United StatesSt. Jude MedicalMinnesotaAF13855MNSt. Paul, MN28240257http://jobs.sjm.com/xml/28240257/jobUSANoneProduction Planner Job Requisition #: 13089 Date Posted: 04/27/2012 Category: Materials Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview The primary function/purpose of this job: Plans, prepares, issues and controls production schedules. Also, coordinates according materials requirements to assure a controlled flow of approved materials timed to meet production requirements. Advices management of the status of work in progress, material availability, and potential production problems to assure that personnel, equipment, materials and services are provided as needed. Schedules equipment and personnel, confirms material supply and demands, prepares work orders or purchase requests for purchase of components or parts based on a master production schedule, shop load and inventory requirements. Coordinates interdepartmental activity with quality assurance, manufacturing, purchasing, engineering, inventory control, traffic, etc. Schedules and expedites the movement of parts by means of move orders, stock transfers and requests for shipping orders. QUALIFICATIONS: Bachelor Degree in Business Administration, Engineering or related field. Three to five years of experience in a manufacturing environment (preferred Knowledge in GMP/ISO9002). Must have good verbal and written communication in English and Spanish. Must have working knowledge in materials/manufacturing systems. Must have leadership/interpersonal skills. Computer Knowledge in programs as; (Excel, Word & Power Point). |E-mail this position Submit Resume or C.V.2012-04-27 19:56:55United StatesSt. Jude MedicalNone13089NoneVirtual, USA28240254http://jobs.sjm.com/xml/28240254/jobUSASunnyvaleSr. Software Development Engineer Job Requisition #: AF13663 Date Posted: 04/27/2012 Category: Software Engineering Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Senior Software Engineer to meet our standard product development needs as well as increase our ability to deliver integrated hardware and software solutions to meet our project specific requirements. Impact this role will have within the AF division: • The Senior R&D Software Engineer designs and develops application software for RF ablation systems. • This role writes product requirement documents, designs, develops code, unit tests and helps out the verification team. Required Qualifications: • Bachelor’s degree in Computer Science, Computer or Electrical Engineering • 7 + years hands-on development experience with real-time embedded hardware, software design and development, and programming experience in C/C++, QT, Object Oriented programming with knowledge of Hardware interfaces and microprocessors • Experience with Linux, or other real time operation system, OS kernel module, device driver development • Familiarity with software configuration and software defect tracking systems • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks • Effective verbal and written communication skills to interact with associates at all levels of the organization, vendors and other SJM entities • Adaptability to frequent change in the work environment • Ability to prioritize responsibilities and ensure deadlines are met • Proficient working knowledge of MS Word, Outlook, PowerPoint, Excel and Project • Experience with 3D image processing, registration and rendering software design, Wireless protocols • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Masters degree in Computer Science, Computer or Electrical Engineering • Experience with RTOS, debugging tools and good software development processes • Working knowledge of entire software development and test cycle with at least one complete FDA regulated medical device product development cycle. Knowledge of applicable international regulations and standards (QSR, ISO 13485, ISO14971) • Formal training in Program/Project Management or Program Management Professional Certification |E-mail this position Submit Resume or C.V.2012-04-27 19:56:25United StatesSt. Jude MedicalCaliforniaAF13663CASunnyvale, CA28240250http://jobs.sjm.com/xml/28240250/jobUSADallasSupply Chain Analyst Job Requisition #: NMD3190 Date Posted: 04/26/2012 Category: Operations Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Supply Chain Analyst will support a multi-plant leading medical device manufacturer. The Supply Chain Analyst will be responsible for bridging the gap between Demand Planning and Production Scheduling, developing appropriate models, data analysis, and reporting/communication systems. The role will centralize around capacity planning, inventory planning, and management of the SAP APO SNP module which drives production plans for all customer facing products. Major, On-Going Responsibilities: • Manage the SAP APO SNP module to ensure finished goods production plans are clearly communicated and prioritized appropriately • Develop and improve the capacity planning process highlighting future capacity constraints from production or external suppliers • Report changes in forecast, inventory, or other factors leading to changes in production and communicate to the business the strategy to overcome the change • Continue to improve inventory reporting across the organization including report automation, inventory adherence, and inventory tracking • Serve as the functional lead for all IT initiatives as they pertain to production planning • Play a key role in developing the S&OP process while providing information for each meeting • Communicate the needs of the business to external production facilities to ensure alignment across the organization • Ensure the production team is informed of changes in forecast and net requirements so resources can be adequately planned • Create business case justification for supply chain projects as it pertains planning, production, and inventory • Monitor all ordering for international geographies using SAP and work collaboratively with the country to determine order size and justifying the quantities • Work with the St Jude sales division to ensure inventory is balanced and ordering is achievable • Support all projects for production, procurement, and planning which includes: IT initiatives, process improvement, and Lean projects • Deliver weekly PSI” reports to production schedulers and highlight concerns • Manage the SNP alerts to ensure the supply chain is balanced • Manage engineering requests for product and enter orders accordingly Other Duties: • Support Divisional initiatives as identified by management in support of Quality Management Systems, • Environmental Management Systems, and regulatory requirements • Continually identify opportunities for improvement Experience & Training: • Bachelor Degree in Supply Chain Management, Operations, or other related field • MBA or MS in a related field a plus • Minimum 5 years experience in a Supply Chain Strategy or Supply Chain Analyst role with a Fortune 500 organization • SAP/APO/DP, Manugistics, or Oracle experience in a production environment preferred • Familiar with Business Objects, SAP BW, or Cognos reporting • VBA and/or SQL programming skill set preferred • Ability to use Microsoft Excel and Access at an advanced level • Ability to communicate clearly to the executive levels |E-mail this position Submit Resume or C.V.2012-04-26 18:12:37United StatesSt. Jude MedicalTexasNMD3190TXDallas, TX28203447http://jobs.sjm.com/xml/28203447/jobUSAWestfordTechnical Marketing Manager Job Requisition #: 13102 Date Posted: 04/26/2012 Category: Marketing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for the management of the department's Technical Marketing function, including establishing and esuring the department's Technical objectives, product planning process and executing field related programs. Essential Functions: •Works effectively on Core Teams in support of new technology, provides support to Research and Development, and the sales force as needed to help develop new product iterations, and provides technical support. Provide Product feedback, comments and suggestions and Competitive information, and work with clinical and marketing on the development of educational modules and materials. •Partner with U.S. Sales Division and International Sales Division to determine technical customer requirements for service and support. •Establish Technical Marketing project priorities and allocate resources and workload •Be conversant with worldwide product portfolio, recommending product additions, deletions, new product ventures and field technical direction •Input to product planning, including product phase-in and phase-out •Provide support for DICOM related issues •Ensure appropriate training and education is provided to those personnel that are involved in the use or application of division products •Liaison with other departments (e.g., Quality, R&D , Legal, Operations, Marketing and Clinical Affairs) for division-wide initiatives •Prepare and manage annual department budget Qualifications: •Bachelor's degree; MBA preferred •10+ years experience •Extensive experience with Technical interface with US and global customers •Strong interpersonal and people management skills •Strong analytical and project management skills •Ability to travel up to 60% Required: •Degree in Engineering, Biological Sciences, Nursing, or a related field. •A minimum of five to seven years of relevant field service and/or clinical experience in hospital enviroment, research, or cardiology, preferably cardiac catheterization laboratory experience. •Preferred minimum of three to five years experience as a field clinical specialist or engineer. •Needs to have a working knowledge of imaging modalities. •DICOM knowledge is essential to position. •Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. •Documented record of delivering information that adds value to management's decision making process. •Demonstrated personal computer skills including spreadsheet, word processing, email, database management, PowerPoint and specialized applications. •Evaluation, originality and/or ingenuity required. •Ability to travel (domestic and internationally) up to 70% and to travel with minimum notice, with the potential for extended periods (up to a week). |E-mail this position Submit Resume or C.V.2012-04-26 18:12:36United StatesSt. Jude MedicalMassachusetts13102MAWestford, MA28203445http://jobs.sjm.com/xml/28203445/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13853 Date Posted: 04/26/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced and team oriented Assembler for our high-tech cardiovascular medical device products. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This position includes a 4 day work week, Monday – Thursday, 10 hours each day for 1st shift. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Performs general housecleaning activities. • Other duties as assigned, such as training support as defined by area Group Leader. Required Qualifications: • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Clear verbal communication skills. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized and team player attitude. Preferred Qualifications: • High school diploma or GED equivalent. • 6+ months of medical device or high-tech industry assembly experience. • Experience with using a microscope. |E-mail this position Submit Resume or C.V.2012-04-26 18:12:24United StatesSt. Jude MedicalMinnesotaAF13853MNMinnetonka, MN28203444http://jobs.sjm.com/xml/28203444/jobUSADallasDirector Mechanical Engineering Job Requisition #: NMD3189 Date Posted: 04/25/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Director of Mechanical Engineering is responsible for effectively leading multi-project product development and implementation efforts of the organization, including management of the financial and technical resources required to accomplish specific mechanical engineering assignments. This individual will provide technical leadership, detailed project planning, and overall organization of group resources to facilitate the engineering of products and processes that meet corporate quality, cost, and scheduling objectives. Major, On-Going Responsibilities: • Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development. Set standards of technical competency and skill development. Create an environment that consistently fosters employee understanding of quality and motivates all employees to actively participate in the process of continuous quality improvement. • Model optimum leadership competencies to inspire an energized, empowered and accountable work force and maintain a strong customer focus. Model ethical behavior, present a favorable community image and actualize ANS management values. • Remain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. Maintain knowledge of current and novel technology through literature, trade journals, university associations, and by attending scientific conferences. Actively pursue development of corporate intellectual property. • Manage Mechanical Engineering resources to accomplish multi-project product research and development. • Establish & enforce procedures to ensure that all products developed meet applicable FDA requirements. • Provide senior management with strategic information, operating plans, and budget requirements, relating to current product development. Work towards the identification of future product opportunities. • Maintain interdepartmental communications to ensure that Mechanical Engineering project activities and goals are effectively communicated and representative of corporate goals. • Provide Mechanical Engineering support and resources as necessary to identify and resolve problems related to the introduction and transition of new product throughout Marketing, Quality, Regulatory, and Manufacturing. Experience and Training: • Bachelors degree or higher in Mechanical Engineering. • Ten years minimum experience in engineering and product development with demonstrated capability and thorough understanding of the product development process. Experience in the medical device industry is preferred. • Five years minimum direct personnel management and related project leadership experience. • Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building. • Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures. • Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired. Other Characteristics: • Individual must be highly motivated and resourceful. • Individual must possess excellent interpersonal skills and have demonstrated ability to motivate technical personnel. • Individual must be comfortable in clinical surroundings and be able to communicate effectively with Physicians and Field personnel. Exemplary analytical, organizational, written and oral communication skills are a must. |E-mail this position Submit Resume or C.V.2012-04-25 19:45:13United StatesSt. Jude MedicalTexasNMD3189TXDallas, TX28179862http://jobs.sjm.com/xml/28179862/jobUSADallasQuality Engineer II Job Requisition #: NMD3188 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision: Supervision will be from Senior or Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:45:10United StatesSt. Jude MedicalTexasNMD3188TXDallas, TX28179860http://jobs.sjm.com/xml/28179860/jobUSADallasSenior Quality Engineer Job Requisition #: NMD3186 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead, coach, and mentor non-exempt and entry level exempt personnel • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Supervision will be from Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 5+ years experience • Demonstrated supervisory experience preferred • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:44:58United StatesSt. Jude MedicalTexasNMD3186TXDallas, TX28179857http://jobs.sjm.com/xml/28179857/jobUSADallasSenior Quality Engineer Job Requisition #: NMD3187 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead, coach, and mentor non-exempt and entry level exempt personnel • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Supervision will be from Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 5+ years experience • Demonstrated supervisory experience preferred • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:44:58United StatesSt. Jude MedicalTexasNMD3187TXDallas, TX28179858http://jobs.sjm.com/xml/28179858/jobUSASylmarEngineer II, Software (requirements) Job Requisition #: 12775 Date Posted: 04/23/2012 Category: Software Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Our Software Requirements Engineering team within the Cardiac Rhythm Management Division located in the suburbs of Los Angeles, CA is seeking talented and skilled Requirements Engineers. The successful candidate for this position will: Gather, analyze, and document detailed software requirements for external instruments supporting implantable cardiac devices, and/or remote patient monitoring and patient care management systems for these devices Write detailed software requirements specifications that describe use cases, functional, user interface, performance, data, and interface requirements Analyze trade-offs between system and clinical requirements, hardware and software architectural constraints, technical capability, and project cost / schedule Perform requirements traceability to system-level requirements, and participate in system / software risk assessment activities Cultivate strong customer and interdisciplinary relationships to acquire product requirements and share information with others to validate assumptions Apply software engineering principles and techniques to solve complex technical problems, identifying potential areas of concern and improvements to products and processes Create and update process definition documentation, including process descriptions, technical specifications, and process models Support the creation of documents necessary for submission to regulatory agencies Requires a BS/MS Engineering-related (EE, CS, or BioMedical) degree and 3+ years of direct experience in requirements engineering discipline. Qualified applicants must have excellent verbal, written, comprehension, analytical, presentation and interpersonal skills. Applicants should have theoretical knowledge and practical experience in software engineering and requirements elicitation methodologies. Additionally, experience in one or more of the following areas is highly desirable: • Cellular communications technology • Database modeling / relational databases • High fidelity UI mockup creation using Fireworks and/or Dreamweaver • Requirements and/or architectural modeling techniques (e.g. UML) • Requirements management and defect tracking tools (e.g. DOORS, Clearquest) • Working with Class III cardiac medical devices • Software lifecycle processes in a highly regulated environment (FDA, ISO, and other regulatory bodies) |E-mail this position Submit Resume or C.V.2012-04-23 20:19:12United StatesSt. Jude MedicalCalifornia12775CASylmar, CA28080470http://jobs.sjm.com/xml/28080470/jobUSAWestfordSr. Engineer - Software Job Requisition #: 12961 Date Posted: 04/23/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview POSITION SUMMARY: Work under the direction of principal engineers to design and develop software for the Lightlab family of cardiovascular imaging products in a FDA regulated environment. Duties include: contribute to requirements specifications and design documentation, implement and test software code, investigate and debug software problems. REQUIRED EXPERIENCE & SKILL QUALIFICATIONS: Minimum 7 years experience in software engineering, in all phases of software development development process. Expert in C++ programming language Expert in object oriented software design Experience designing and implementing real time and/or high performance systems Experience with Microsoft Windows software development environment DESIRED SKILLS: Experience designing and implementing user interfaces. Experience interfacing with hardware devices Experience with data acquisition systems Experience in medical device industry Experience in FDA (or other) regulated development environment Experience in medical imaging EDUCATIONAL QUALIFICATIONS: BS in computer science, electrical engineering or other related engineering discipline |E-mail this position Submit Resume or C.V.2012-04-23 20:19:12United StatesSt. Jude MedicalMassachusetts12961MAWestford, MA28080471http://jobs.sjm.com/xml/28080471/jobUSASt. PaulMachinist Job Requisition #: 13027 Date Posted: 04/23/2012 Category: Production Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview This is a Second Shift position. Sets up, calibrates, and operates metal fabricating equipment. Essential Functions: • Set up, calibrate, and operate machining equipment used to produce or modify parts or products. • Inspect machining operations and finished product against specified tolerances using precision measuring tools. • Determine and correct minor machine malfunctions. • Perform routine maintenance and cleaning on machines and equipment Qualifications: • Two year technical degree in Machining or 5 years experience in a machine shop required |E-mail this position Submit Resume or C.V.2012-04-23 20:18:57United StatesSt. Jude MedicalMinnesota13027MNSt. Paul, MN28080464http://jobs.sjm.com/xml/28080464/jobUSAWestfordSoftware Engineer - Senior Job Requisition #: 12982 Date Posted: 04/23/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Intravascular Optical Coherence Tomography (IVOCT) is a new imaging modality capable of providing high resolution images of arterial vessels. The need for fast and reliable interpretation of these images is becoming increasingly important as they can provide potentially life saving information. Relying solely on human interpretation can be expensive and time consuming, not to mention prone to inconsistency and errors. We are seeking a talented individual to join our development efforts in the design and implementation of different image segmentation and characterization algorithms. As a member of our group, independent and collaborative work are both expected during the development and implementation of new algorithms. The successful candidate should be able to understand requirements, objectively analyze problems and efficiently design and implement solutions as well as clearly document his work. Requirements - Strong C/C++ skills. - Demonstrated experience with applied image processing and/or analysis. - A degree (preferably graduate degree) in Computer Science or any related area. - At least 5 years of commercial development experience (preferably on a windows platform). - Experience with SIMD CPU and/or GPU programming is a plus. - Familiarity with source control and bug tracking tools. - Good English communication skills, oral, reading and writing (should be comfortable reading scientific publications). - Ability to work both autonomously and within a team. |E-mail this position Submit Resume or C.V.2012-04-23 20:18:42United StatesSt. Jude MedicalMassachusetts12982MAWestford, MA28080448http://jobs.sjm.com/xml/28080448/jobUSAWestfordVP - R&D Job Requisition #: 12984 Date Posted: 04/23/2012 Category: Research Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview VP of R&D Position Summary: Responsible for defining strategic product goals for the division and for directing the R&D department. Establishes current and long range objectives, plans and policies. Provides guidance for the design and development of company products. Works closely with Regulatory Affairs/Quality Assurance personnel (internal or external) to determine appropriate regulations and maintain regulatory compliance. Leads the cultural development of the department to provide a positive work environment. The Vice President is also responsible for following established quality system practices. Essential Functions: •Establish the strategic direction of CVD Massachusetts R&D function to ensure new product development enhancing St. Jude's market position. •Establish product development milestones and long term strategic product plan to meet the evolving clinical and economic requirements of diverse global healthcare systems. •Represent the company as appropriate in its relationships with major customers, suppliers, competitors, government agencies, professional societies and similar groups. •Determine and monitor the department's financial requirements, ensure budget and organizational adequacy. •Identify and interface with customers to bring customer requirements to employees of St. Jude Medical. •Establishes and maintains an effective system of communications throughout the company to ensure department milestones and contributions are achieved and appropriately understood. •Plan for the development of people and maintains programs which will encourage successful future management of business. •Participate in the assessment of new technologies and companies outside of St. Jude Medical. •Contribute to the development and expansion of the Company's intellectual property assets. •Ensures quality compliance through leadership and compliance in all product development activities. •Monitor the effectiveness of the quality system as it pertains to R&D and modify/update the procedures as needed together with quality system management. Qualifications: •A four-year degree in Science or Engineering, or a field related to the medical device industry; Advanced degree preferred. •15-20+ years of experience in the medical device industry. •Successful product development and release track record of complex medical devices: Capital equipment, Catheters, Software •Experience leading and/or managing a medical device engineering team. •Experience in developing and building a company in a fast-paced, speed to market culture. •Excellent written communication skills and interpersonal skills. |E-mail this position Submit Resume or C.V.2012-04-23 20:18:15United StatesSt. Jude MedicalMassachusetts12984MAWestford, MA28080437http://jobs.sjm.com/xml/28080437/jobUSAWestfordSupervisor - Quality Job Requisition #: 12983 Date Posted: 04/23/2012 Category: Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: The Quality Supervisor position is responsible for managing the daily quality inspection and QA release activites to support operations. Essential Functions: • Provide daily supervision, work direction and training to staff at multiple sites. • Develop and maintain a competent work group through effective hiring, communications, recognition, performance feedback and development. • Monitors, directs and prioritizes workload to assure customer requests and expectations are met. • Works directly with operation to support production goals and contribute to production planning for appropriate allocation of resources. • Support all facilities as necessary via training and troubleshooting document control. Contributes to establishing departmental goals and objectives. • Provide support to other departments as required. • Provide department status updates to Management. • Identify and provide solutions to improvement opportunities. • Resolve conflicts. • Motivate team to achieve results. • Foster a culture of continuous improvement. • Write monthly report to communicate status of goals and objectives to Management. • Ensure departmental compliance to procedures. • Maintain departmental procedures to ensure compliance. Other Duties: • Support divisional initiatives as defined by management, Quality Management Systems and Environmental Management systems as well as other regulatory requirements. Accountability/Supervision: • Resolve conflicts between department members and customers. • Receives monthly direction from Documentation Relationships: Describe contacts and purpose of relationships. Internal: All departments. External: Suppliers of imaging services. Equipment: • Computers, scanners, printers, copiers • Standard office software programs • ERP databases (SAP) • PDM Working Conditions: • General office environments. Physical Demands: • See ADA Factors Qualifications: • 5+ years supervisor experience • High school degree required; Bachelors degree preferred • Previous Quality inspection, technician or engineering experience required • Knowledge of FDA, GMP, and ISO 13485 • Strong communication and leadership skills • Prior medical device experience preferred • Solid communication and interpersonal skills • Be able to direct or guide departmental personnel. • Solid computer skills and report writing skills |E-mail this position Submit Resume or C.V.2012-04-23 20:18:14United StatesSt. Jude MedicalMassachusetts12983MAWestford, MA28080435http://jobs.sjm.com/xml/28080435/jobUSASylmarReimbursement Specialist Job Requisition #: 13075 Date Posted: 04/23/2012 Category: Reimbursement Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, collaborates with others to support internal and external customers for Reimbursement. Supports department in reimbursement clinical trial budgetary process. Insures that Clinical Trial compensation processes adhere to Company policies and meet compliance standards. Responsible for assisting sites in the appeal process, and other related matters utilizing a very specialized knowledge of the Medicare Reimbursement procedures as well as private payers. Conducts data analysis utilizing Medicare data, procedure codes, hospital payment codes and other claims data. Promotes the process of continuous quality improvement and applies clinical principles to the solutions for technical issues. Exercises considerable judgment in planning and organizing work. Requirements/Education: Bachelors Degree in Business Administration, Bachelors Degree inof Science, or Nursing Degree, or equivalent academic discipline. A minimum of three years of analytical experience involving coverage policies, procedures, and regulations, including but not limited to: Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals. Demonstrate a working knowledge of coding, Diagnostic Related Group (DRG) assignments, Ambulatory Payment Classification (APC) categorization and process. Demonstrated knowledge of federal, state and industry rules and regulations governing technical aspects of reimbursement and compliance. National and Local Coverage Policies (NCD and LCD) Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, multi-task, prioritize such task, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential. Demonstrated discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet skills, word processing, database management and other relevant applications. Desired Requirements: Previous related experience in reimbursement for medical device, or pharmaceutical company. Registered nurse, legal, clinical research associate experience desired |E-mail this position Submit Resume or C.V.2012-04-23 20:17:54United StatesSt. Jude MedicalCalifornia13075CASylmar, CA28080425http://jobs.sjm.com/xml/28080425/jobUSAPlymouthSenior IT Business Analyst Job Requisition #: 13033 Date Posted: 04/23/2012 Category: Information Technology Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary: Provides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments. Essential Functions: Provides application development support and coordination primarily to the Clinical organization by: • Facilitating meetings in the business area to review business processes and identify information system requirements and/or needs. • Making appropriate recommendations for continuing, modifying, or abandoning proposed projects and/or systems based on the results of feasibility studies and/or cost/benefit analyses. • Maintaining and documenting the logical and physical data models including data flow diagrams. • Developing business process flows and data models required by the department methodology for new system development or for process redesign. • Preparing project and system documentation consistent with standards and procedures outlined in the development methodologies. Provides project management support as a leader or member of a project team: • Develops project plans, work breakdown structures and task dependencies, communication plans, etc., according to the development methodologies. • Manages project activities and motivates members of the project team. • Provides updates and thorough communication to the project team, information systems and the impacted business areas. • Coordinates the implementation of information systems with IS personnel and members of the impacted business areas. Provides coaching and training support: • Maintains proficiency in the tool sets used within the supported business areas. • Supports the business areas in their tool sets, including training and developing subject matter experts within the supported business areas. • Conducts training that quickly prepares participants to use a maximum of system features. Maintains relationships and communications with business and IS units: • Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals. • Understands the various business entities, their information systems developed by IS, and the applications that they developed on their own. • Serves as a liaison between IS and the supported business areas. • Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems. • Provides effective written and verbal communications. Qualifications: • This person must have excellent communication and customer service skills and strong leadership and team motivation skills in order to manage work that requires effective delivery to internal SJM customers. • This includes bridging communication between technical areas and business areas for a full and complete understanding of expectations. • Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience in Clinical or a related function. • Bachelor's degree in Business, Computer Science or related field is preferred. • MBA a plus. |E-mail this position Submit Resume or C.V.2012-04-23 20:17:20United StatesSt. Jude MedicalMinnesota13033MNPlymouth, MN28080404http://jobs.sjm.com/xml/28080404/jobUSADallasSenior Accountant Job Requisition #: NMD3185 Date Posted: 04/20/2012 Category: Finance Accounting Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working without appreciable supervision, assist in all aspects of month-end close, performs variance analysis of General Ledger accounts, performs reconciliation of more complex balance sheet accounts, responsibility for intercompany activity & reconciliations. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager. Assures that quality of services meets internal and external customer requirements. Interacts with various levels within organization, providing support and direction in the area of general accounting. Remains current on developments in field(s) of expertise. Major, On-Going Responsibilities: • Assist in month end close, to include journal entry preparation & account analysis. • Perform review/analysis of operating expenses, working with cost center owners to identify trends and required adjustments/reclassifications. • Reconciliation of complex balance sheet accounts, including but not limited to accruals for: Benefits, Wages, Royalties, Warranties and Legal. • Intercompany manual billings & reconciliations, both US and International. • Provides support to the financial planning group in the budgeting/forecast process. • Provides guidance for Staff Accountant and serves as backup for fixed asset accounting duties. • Responsible for completion of Government surveys for submission to Corporate. • Preparation of ad-hoc reports & analysis upon request. Experience & Training: • Bachelors Degree in Accounting, Finance, or related field. • 5-7 years of progressively more responsible general accounting experience. • Experience in a manufacturing environment is preferred. • Must have a strong knowledge of accounting & understanding of GAAP principles. • Must have experience with significant ERP systems (SAP preferred). • Knowledge of Hyperion reporting tool is preferred, but not required. • Microsoft Office proficiency, stressing advanced Excel skills. • Strong analytical skills, with strong attention to detail. Other Skills/Characteristics: • Strong verbal & written communication skills. • Ability to multitask and manage a diverse workload. Effective interpersonal skills and the ability to work in a team environment. |E-mail this position Submit Resume or C.V.2012-04-21 19:01:51United StatesSt. Jude MedicalTexasNMD3185TXDallas, TX28061179http://jobs.sjm.com/xml/28061179/jobUSAPlymouthClinical Research Associate Job Requisition #: 12963 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate will manage and execute assigned clinical studies with guidance. This will include Support professionalism and scientific expertise of department. Responsibilities: Manages assigned clinical study centers Sets up sites: clinical research agreements, site budgets, IRB Approvals, etc Prepares and maintains case report forms, informed consent and other specialized documents for clinical investigations Conduct study training or other formal training at site and at the study team level Assists Regulatory in annual report and progress reports to the FDA Reviews data forms and DCF generation Responsible for data review and approval of DCFs Generates presentations when requested by investigators Acquires professional, product and market expertise via independent reading, networking and training Travels approximately 30% but varies according to trial needs Participates in professional activities outside of normal business hours Performs other related duties as requested Requirements: BA/BS in business, science or nursing 3-5 years experience in clinical research including monitoring Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization Excellent written and verbal communication skills Ability to work independently and take direction from others |E-mail this position Submit Resume or C.V.2012-04-20 18:10:04United StatesSt. Jude MedicalMinnesota12963MNPlymouth, MN28034728http://jobs.sjm.com/xml/28034728/jobUSAPlymouthAssociate - Clinical Research Job Requisition #: 12962 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate II position will assist in the planning, designing, and execution of clinical studies under the supervision of the Clinical Manager with focus on compliance to applicable regulatory standards and monitoring of investigational centers. Responsibilities: • Assist with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools. • Initiate site activation documentation • Participate in site qualification and site initiation process, including scheduling of monitor activities with site personnel. • Assist in planning and preparing materials for investigator and coordinator meetings. • Assist in training of investigators and coordinators. • Track and report progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events. • Coordinate and conduct monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports • Assist in query generation and resolution. • Assist with core lab data management. • Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues. • Write and/or provides input to the monitoring plan • Provide updates on progress of assigned clinical sites to study management. • Develop expertise with SOP's, GCP's, and regulatory compliance guidelines. • Participate in training/orientation or new employees. • Contribute to ongoing SOP review and development. • Review site changes to informed consent forms. • May create and conduct presentations. Qualifications: • Four year degree in physical science • 1-2 years experience monitoring • Experience directly supporting clinical research or similar experience in a medical/scientific area • Knowledge of clinical and outcomes research study design • Working knowledge of GCPs, and regulatory compliance guidelines for clinical trials • Knowledge of medical terminology • Able to travel 40% on average • High attention to detail and accuracy • Strong written and oral communications skills • Able to manage multiple tasks • Good problem-solving skills • Proficient computer skills (MS Office) • Current driver's license Preferred Qualifications: • Two years applicable health care experience • Advanced degree |E-mail this position Submit Resume or C.V.2012-04-20 18:09:59United StatesSt. Jude MedicalMinnesota12962MNPlymouth, MN28034726http://jobs.sjm.com/xml/28034726/jobUSAMinnetonkaSenior Continuous Improvement Engineer Job Requisition #: AF13832 Date Posted: 04/20/2012 Category: Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Sr. Continuous Improvement Engineer to work directly with all departments within the organization, under minimal supervision, to provide hands on implementation of Six Sigma and Lean methods. Identify and prioritize opportunities for improvement within the design, development, test, validation, and manufacturing of medical devices. Drive improvement projects to closure utilizing Lean and Six Sigma approaches and tools. Impact this role will have within the AF division: • Identify and prioritize improvement opportunities across the organization which would benefit from the utilization of Lean and/or Six Sigma tools and approaches. Establish project scopes, priority, and appropriate goals. • Complete major projects and key initiatives. Lead, facilitate, or support cross functional teams on small (Kaizen) to large (breakthrough) CI projects, from Define to full implementation and Control. Utilize Lean/ Six Sigma methodologies and tools. Apply engineering and scientific principles to the evaluation and solution of technical problems. Assure projects are completed on time and within budgets. • Facilitate workshops to educate employees in Lean and Six Sigma methodologies and tools. May develop or augment training materials for use in these workshops. • Mentor and provide support to other CI team members during project scoping, utilization of CI tools, and driving improvement projects to closure. • Assist with data collection and data analysis Required Qualifications: • Bachelor’s Degree in Engineering (preferred) or other scientific discipline • Lean/ Six Sigma Black Belt certification • Minimum of 6 years of progressively more responsible work experience in a technical discipline as well as leadership experience. • Experience with Lean/Six Sigma tools such as Process Flow Diagrams, Cause & Effect, Measurement System Analysis, Pull Systems, Design of Experiments, Design for Manufacturability, Quality Function Deployment, Voice of the Customer. • Demonstrated experience as documented with actual project work with results • Knowledge of statistics (basic, hypothesis testing, ANoVA, DoE, etc.) • Strong facilitation skills and team leader experience • Organized and detailed project management skills • Ability to work independently as well as a member of a team. • Excellent written and verbal communication skills • Strong quantitative, analytical and process redesign skills; innovative thinking skills Preferred Qualifications: • Experience in Medical Device or another highly regulated industry is preferred but not required. |E-mail this position Submit Resume or C.V.2012-04-20 18:09:13United StatesSt. Jude MedicalMinnesotaAF13832MNMinnetonka, MN28034692http://jobs.sjm.com/xml/28034692/jobUSAPlymouthSenior Clinical Safety Specialist Job Requisition #: 12987 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Senior Clinical Safety Specialist will work under the direction of the Senior Director, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects. Responsibilities: • Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting • Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings • Oversee weekly review of adverse events with applicable study teams • Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP) • Code adverse events where directed by the governing processes • Draft AE narratives, as required, for inclusion in all FDA report submissions • Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events • Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products • Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting • Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department • Assist in development of study specific case report forms • Assist in clinical study protocol development • Assist with BIMO audits, when directed • Collaborate on additional Clinical Research activities, as needed • Other duties as assigned Requirements: • Bachelor’s degree in an area of science or RN • Strong understanding of adverse events and risk assessment One of the following: • 2-5 years experience within pharmacovigilance or medical safety • 5+ years experience in medical device or Pharma in clinical research or risk assessment • Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards • Proficient in MS Office and database navigation skills • Strong interpersonal and communication skills • Excellent record keeping, organizational skills, and problem solving abilities • Highly motivated and capable of working independently and as a team member • Experience coordinating, prioritizing, and setting timelines for multiple tasks • Ability to multi-task and adapt to a rapid pace environment • Strong technical writing skills Preferred qualifications: • 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena • PharmD or PhD |E-mail this position Submit Resume or C.V.2012-04-20 18:09:08United StatesSt. Jude MedicalMinnesota12987MNPlymouth, MN28034690http://jobs.sjm.com/xml/28034690/jobUSAMinnetonkaSr. SAP Business Analyst Job Requisition #: Corp 12031 Date Posted: 04/20/2012 Category: Information Technology Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview St. Jude Medical is continuing to work through a multi-year SAP implementation while adding new phases. The Sr. SAP Business Analyst supporting the Finance implementation will lead medium-sized projects to implement changes on behalf of the business. They will analyze business and technical processes, document business requirements, define changes to business processes and assist in modifying them, configure, test and implement enterprise-wide business systems. Additionally they will interview business partners to define detailed business requirements, maps current processes to the desired state and identify gaps, such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls. Where appropriate, they will translates business requirements to functional specifications and technical requirements, serve as the primary point of coordination and communication for a business domain to the business process owner and coordinate with business and technology teams to provision and test business systems to ensure they meet requirements. Job Duties: Collect and Document Requirements • Defines business needs by analyzing and documenting business processes; includes research, planning, writing user cases and project overviews, plus any supporting documentation • Gather requirements from customers to identify desired support needs • Based on data gathered, scope the project and technical domain for the solution • Prepare project and system related documentation consistent with standards and procedures outlined in the applicable development methodologies Defining Solutions • Perform feasibility studies and/or cost/benefit analyses in support of various initiatives • Maintain and document the logical and physical data models including data flow diagrams • Develop as-is and to-be business process flows and data models required by the department methodology for new system development or for process redesign Serve as Interface between Business and Technical Teams • Understand the system interactions across the associated business domain and identify when business requirements complement/conflict with one another. Communicate the impacts of change in one system to other systems • Lead meetings in the business area to review business processes and identify information system requirements and/or needs • Understand the various business entities and cross divisional relationships • Serve as a liaison between IS and the supported business areas • Communicate effectively with management to enhance their understanding of the opportunities and limitations of information systems Coordinate Execution of Initiatives • Coordinate support enhancements and large scaled IT initiatives • Lead project teams consisting of intermediate and associate Business Analysts • Develop Test Plans, Cases, and Scripts and perform and coordinate Testing • Develop and deliver end user training • May work on multiple projects at one time Other Duties • Serve as a business domain expert for the company, informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals • Provide updates and communication to customers, management and IT; escalate issues as appropriate • Other duties as assigned General Qualifications: • Bachelor’s Degree in Computer Science, MIS, Mathematics, Engineering, Business or area of functional responsibility preferred, or equivalent 10 years of industry work experience • 8 years of industry experience in a technical profession • Experience working in a broader enterprise/cross division business unit model • Ability to work in a highly matrix and geographically diverse business model • Ability to work effectively within a team and as an individual contributor in a fast paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner • Extremely strong verbal and written communications with ability to effectively communicate at multiple levels in the organization • Ability to recognize communications difficulties, diagnose the symptoms at the core, and work diplomatically to resolve them • Strong organizational, attention to detail and task follow-up skills. • Adept at handling multiple assignments in a timely manner and meeting assigned deadlines • Ability to travel approximately 10% Technical Qualifications: • Solid accounting knowledge and understanding of Finance and Controlling postings from other SAP modules • Solid understanding of the sections of the Financial Statements and how they are configured and appear in SAP • Strong analytical and reconciliation skills – sees to the details • Experience in SAP configuration – both the more common place items as well as the ability to research and implement configuration that may be new to the applicant • Good process documentation skills • Experience in the system testing process including documenting results • A general knowledge of SAP interface processes • Understand the effects of SAP FI and CO postings in multiple currencies and how to reconcile these differences • Strong understanding of intercompany transactions and reconciliation process in SAP • Ability to assess the cost/benefit of complex or non-scalable design requests and influence the decision makers |E-mail this position Submit Resume or C.V.2012-04-20 18:08:53United StatesSt. Jude MedicalMinnesotaCorp 12031MNMinnetonka, MN28034684http://jobs.sjm.com/xml/28034684/jobUSAWestfordEngineer Principal - Quality Job Requisition #: 13060 Date Posted: 04/20/2012 Category: Process Development Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support. Essential Functions: • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel. • Leads multifunctional teams in completing program directed or continuous improvement activities. • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Expected to independently and effectively make data based decisions with respect to individual and project team deliverables. Able to independently perform core team member role. Able to manage and mentor technicians and lower levels of engineering. Qualifications: • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred • 10+ years experience • Demonstrated supervisory experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Demonstrates technical leadership within the department and outside the department • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-20 18:08:30United StatesSt. Jude MedicalMassachusetts13060MAWestford, MA28034677http://jobs.sjm.com/xml/28034677/jobUSASt. PaulScientist - R&D Job Requisition #: 13061 Date Posted: 04/20/2012 Category: Research Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview The successful candidate will serve as a Subject Matter Expert (SME) in the R&D Science & Technology Group in thermal analysis techniques such as DSC, TGA, and DMA. • Responsible for providing technical expertise, consultation and project support. • Manage analytical technology selection and test method development to support medical device material selection, process optimization, and device design. • Provide guidance in method validation, support existing product development and proactively provide analytical solutions for design and device issues. • Assist in designing and conducting method validation/improvements for testing medical implants and materials. Position will provide test method validation advice based on conclusions from test method development activities. • Individual will also be responsible for providing leadership through coaching, mentoring and developing technical staff. Education and Experience Requirements: • PhD with 0-2 years, MS with 2-5 years or BS with 5-8 years of relevant product development expertise required. • Expertise in analytical science or engineering with focus on test method development/validation of thermal analysis techniques is required. • Individual must communicate well with all levels of management and employees. Individual must also work well in collaborative environment across functional areas. • Possess background in commonly used analytical technologies (Chromatography, Thermal analysis, Spectrometry) • Working knowledge of Confocal Raman and FTIR analytical technologies • Knowledge of method validation in a highly regulated working environment • Familiar with analytical methods used to assess safety and efficacy of medical materials/devices • Knowledge of industry standards for materials characterization; openness for change Willingness to perform hands on lab work. • Compliance-minded and quality oriented. Concise, organized, can multi-task with the ability to prioritize. • Previous experience with R&D product development teams in medical device industry desired. |E-mail this position Submit Resume or C.V.2012-04-20 18:08:30United StatesSt. Jude MedicalMinnesota13061MNSt. Paul, MN28034676http://jobs.sjm.com/xml/28034676/jobUSAAustinManager, Marketing Communications Job Requisition #: USD 9588 Date Posted: 04/19/2012 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview This position will require someone who can quickly assess the marketing opportunity and apply their 8+ years of experience to execute the project, understand the end-goal, and create a compelling communication plan to address the needs of the sales force. The individual that fills this role will have an impact on the messaging and marketing of the growth-driving technologies that will propel St. Jude Medical into a leadership position in the medical device marketplace. Overall, accountability in owning the outcome of the project and its impact on business will set up a successful career at St. Jude Medical. This role has management responsibility for the development and implementation of a complete, multi-channel marketing communications program to support and enable sales in the US. He/she will develop strategically impactful campaigns to support the launch of new products and will build promotional programs around key conventions. Utilizing both traditional and multi-media to reach established goals, the performance of routine analysis and reporting success metrics will help establish a best-practice within the Marketing department. This Manager will work across multiple stakeholders to ensure the MarCom strategies are effectively implemented and executed to achieve their communication objectives. The US Sales Force receives one primary communication from Marketing on a weekly basis the SmartBrief. The SmartBrief is a key channel for communicating marketing messages internally and as such, this person will provide oversight to its direction and execution. The ability to influence contributors and those that create and review the content will be of the upmost importance and the key to success in growing and sustaining this important internal communication channel. Therefore, the Manager must work well in a team setting and must collaborate across matrixed-organizational lines. The ideal candidate will have an extreme attention to detail and excellent written and verbal communication skills. The applicant will need to have a positive and hard-working attitude and exhibit strong, collaborative leadership skills. This highly organized individual must be able to manage multiple projects at once, prioritize and maintain a busy schedule (including domestic travel) and meet deadlines. Of course, this person must embrace challenges, some ambiguity, and apply creative-thinking to all projects in order to be successful. Must thrive in a fast-paced, lean environment, developing efficient and effective means to gain alignment and resolve issues/address obstacles. Must be willing to quickly learn the clinical domain, the complex selling process and the unique challenges and market dynamics that will affect business and communication strategies. Key personality traits include: adaptability, agility and flexibility, as well as a positive attitude. Applicants must have 8+ years of experience and should be able to show a steady growth and increase in responsibilities, leadership and mentoring of colleagues, as well as demonstrated successes. Knowledge of regulated industries, ideally cardiology, neurology and/or medical devices, will factor in to the decision to pursue next steps in the interview process. These things, plus a desire and passion for a marketing communications career, should be clearly articulated in the cover letter which accompanies the resume. Requirements/Education: A Bachelors degree in Public Relations, Journalism, Advertising, Communications or equivalent plus at least eight years of progressively more responsible experience in the communications field, especially in Sales/Marketing focused organizations. Healthcare marketing background. Prior management of a small team Desired Requirements: Advertising agency and corporate marketing experience. Involvement in media planning and event planning. Understanding of internal communications and sales force enablement programs. Mobile app development and deployment. Spanish language skills. |E-mail this position Submit Resume or C.V.2012-04-20 18:08:25United StatesSt. Jude MedicalTexasUSD 9588TXAustin, TX28034675http://jobs.sjm.com/xml/28034675/jobUSASt. PaulSystems Software Principal Engineer Job Requisition #: AF13720 Date Posted: 04/20/2012 Category: Systems Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Principal Systems Software Engineer to join our St Paul, Minnesota based team. Within this role, the Principal Systems Software Engineer will be responsible for designing, implementing and testing system software functionality from internal and external customer requirements and clinical feedback. Impact this role will have within the AF division: • Enhance build system and processes to create a self-service environment. • Architect Tools and Infrastructure to facilitate software development, software configuration management and software release management. • Construct interfaces between systems. • Enable access to information using Web based technology. • Perform automation and test framework improvements. Required Qualifications: • Bachelors degree in computer science, electrical engineering or other related discipline. • 10+ years Software Engineering experience. • Expert in Perl, Shell, C/C++ programming language. • Experience working with Unix/Linux systems. • Thorough knowledge of software build tools including Qmake, Cook, static/dynamic linking.and similar mechanisms. • Experience with Perforce and similar Software Configuration Management tools. • Strong data-mining, analysis and report writing skills. • Knowledge and implementation of automation suites, structure, maintenance. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Medical device industry experience. • Strong Networking background – TCP/IP, NIS+, LDAP, DNS, SNMP, etc. • InstallAnywhere or other installers for software packaging and delivery. • Object oriented software design. • Experience with Klocwork or other static analysis tools. • Continuous Integration systems. • Experience with Microsoft Windows compilers and build systems desirable. • Experience with Jenkins. • Polished communicator- written documentation and oral presentations/ discussions/ meetings |E-mail this position Submit Resume or C.V.2012-04-20 18:08:24United StatesSt. Jude MedicalMinnesotaAF13720MNSt. Paul, MN28034674http://jobs.sjm.com/xml/28034674/jobUSANoneBuyer Job Requisition #: 13008 Date Posted: 04/19/2012 Category: Materials Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Assures on time delivery of all material and/or supply required for the manufacturing and operations of St. Jude Medical P.R. LLC to ensure that production supply lines and operations are uninterrupted. Expedites all materials shipped from any local supply vendor as well as from U.S. divisions. Requirements/Education: Bachelor Degree in Business Administration, Engineering or related field. Three to five years of experience in a manufacturing environment (preferred Knowledge in GMP/ISO9002). Must have good verbal and written communication in English and Spanish. Must have working knowledge or materials/manufacturing systems. Must have leadership/interpersonal skills. Computer Knowledge in programs as; (Excel, Word & Power Point). |E-mail this position Submit Resume or C.V.2012-04-19 18:49:05United StatesSt. Jude MedicalNone13008NoneVirtual, USA28008685http://jobs.sjm.com/xml/28008685/jobUSASt. PaulCustomer Service Rep I Job Requisition #: USD 9586 Date Posted: 04/19/2012 Category: Customer Service Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview This position is contract to hire with a 9:30am to 6:30pm shift. Using established principles of effective customer service, provides sales order and/or inventory management support to sales representatives, hospitals, clinics and physicians. Processes customer orders submitted via multiple channels, including phone, fax, Electronic Data Interchange and e-mail. Provides inventory support for products and services. Completes administrative functions to support order processing. Requirements/Education: High school equivalency required. Bachelors degree preferred. Typically a minimum of two years of experience in a customer service position. At least one year of experience with SAP software preferred. History of technical aptitude and ability to learn new applications and functions quickly and comfortably. Demonstrated history of creativity and initiative in anticipating and solving customer problems. History of effective de-escalation and problem-solving in conflict situations. General knowledge of order processing techniques and finished goods distribution process. Proven high level of interpersonal and communication skills, including the ability to listen, resolve problems, deal with unresolved issues, delays and unexpected events. Must possess demonstrated keyboard and personal computer skills (experience with Microsoft Office, including Excel, Word, Outlook and PowerPoint). Typing proficiency of at least 45 words per minute. Good mathematical, record keeping, organizational and problem-solving skills. Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously. |E-mail this position Submit Resume or C.V.2012-04-19 18:49:00United StatesSt. Jude MedicalMinnesotaUSD 9586MNSt. Paul, MN28008674http://jobs.sjm.com/xml/28008674/jobUSAAustinProgrammer Analyst II Job Requisition #: USD 9583 Date Posted: 04/19/2012 Category: Information Technology Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under general direction maintains business application systems and creates new systems. Works with project management office to prepare level of effort estimates based on user requirements. Performs systems analysis, programming, problem resolution and internal consulting for new and existing technical systems applications, including vendor packages. Analyzes and revises system logic, coding and documentation as necessary. Bachelor’s degree in Information Systems, Computer Science or equivalent degree in a pertinent discipline required and 8 plus years of systems analysis, design, programming and testing experience. Broad knowledge of .NET, C#, HTML and JavaScript; experience with Relational databases and some form of SQL. Microsoft SQL Server experience preferred. Experience with Microsoft Sharepoint is preferred. Understands the challenges in developing in mobile environments and various technologies related to iPhone, Android, and Blackberry. Demonstrated experience working on large projects in a team environment. An understanding of system architecture principles as well as a variety of databases, procedural languages and data communications is required. Ability to translate client requirements into a feasible design solution. Demonstrated ability to use proper coding techniques and efficiencies, testing methodologies, with an understanding of the operating system. Planning, organizational, interpersonal and communication skills. Demonstrated verbal and written analytical/problem solving, communication, interpersonal and presentation skills required sufficient to conduct discussions, interviews, negotiations, and give presentations. Must be able to handle multiple projects simultaneously. Demonstrated personal computer skills including spreadsheet, word processing and data base management. |E-mail this position Submit Resume or C.V.2012-04-19 18:48:40United StatesSt. Jude MedicalTexasUSD 9583TXAustin, TX28008646http://jobs.sjm.com/xml/28008646/jobUSAScottsdaleSenior Quality Engineer Job Requisition #: 13049 Date Posted: 04/19/2012 Category: Quality Location: Scottsdale - AZ - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Scottsdale, Arizona: Job Overview This is an exciting opportunity for a skilled quality engineer who is interested in building life saving devices while interacting with multiple sites across the U.S. and globally. Working within a small team, within the first 6 months on the role, the Senior QA engineer will come up to quick speed on the daily component and process issues that happen within the hybrid build process while providing guidance to the inspectors on visual criteria interpretation. On a long term basis, the expectation is to have the engineer be fully integrated in the hybrid manufacturing culture while participating in activities and investigations related to our customers at other manufacturing sites (Sylmar, Puerto Rico, Malaysia and South Carolina). Will work closely with Engineering to define hybrid acceptance criteria for new components/ products; to create Quality plans for new products Requirements/Education: Bachelors Degree in Electrical or Mechanical Engineering. Minimum 5years of QA experience, working directly on a microelectronics manufacturing environment, solving day to day problems and dealing with people at all levels of the organization. Broad cross-disciplinary and in-depth knowledge of the quality engineering profession. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering quality engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. |E-mail this position Submit Resume or C.V.2012-04-19 18:48:23United StatesSt. Jude MedicalArizona13049AZScottsdale, AZ28008616http://jobs.sjm.com/xml/28008616/jobUSAAustinInventory Analyst Job Requisition #: USD 9579 Date Posted: 04/18/2012 Category: Operations Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under direct supervision, assists to support the development and implementation of policies and procedures needed to maintain USD inventory levels of SJM products. May assist in the maintenance of necessary files, documents, and reports as required. Applies business principles and methods normally acquired in a recognized four-year course of study. Recommends, interprets and implements USD specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field of expertise. Requirements/Education: Requires a Bachelors Degree in business administration or a related discipline and a minimum of 2 plus years related customer service, purchasing, material management, or warehouse experience. Broad cross-disciplinary and in-depth knowledge and application of advanced concepts and practices of discipline. Demonstrated ability to perform intermediate level word processing and spreadsheet tasks using software such as Microsoft Word and Excel. Demonstrated knowledge of an Enterprise Resource Planning (ERP) system or Material Request Planning (MRP). . |E-mail this position Submit Resume or C.V.2012-04-18 20:56:11United StatesSt. Jude MedicalTexasUSD 9579TXAustin, TX27985101http://jobs.sjm.com/xml/27985101/jobUSADallasSenior Manufacturing Engineer Job Requisition #: NMD3184 Date Posted: 04/18/2012 Category: Mechanical Design Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Senior Manufacturing Engineer will develop and improve processes and equipment to facilitate the manufacture of new, redesigned, and current products that will meet established specifications and will conform to established cost limits. Emphasis on continuous engineering and design enhancement of existing products. Support in new product/process development. Responsibilities include: • Evaluate and recommend vendors, tools, material, and equipment to determine if they can be used in manufacturing of products. • Design, document, and verify tooling for the manufacturing processes. • Document production processes. • Prepare and conduct technical and nontechnical training sessions on assembly and test techniques. • Understand quality requirements of customers and regulating bodies, and use quality tools to improve processes. • Make recommendations regarding proposed designs to assure that products can be produced in conformance with specifications and customer requirements. • Prepare and conduct qualifications and validations of processes. • Support continuous engineering and design enhancement of current products to improve quality and cost. • Perform necessary mechanical qualification and verification testing for design modifications. Experience and Training • Bachelor’s degree in Mechanical Engineering/related engineering field. • Minimum 5 years experience in Engineering environment, medical device preferred. • Minimum 2 years experience in CAD systems. • Knowledge of PC applications. • Understanding of DOE, SPC, and Lean Manufacturing. • Six Sigma experience/certification a plus. • Ability to work independently and in a team environment. • Good organization skills and attention to details. • Excellent interpersonal and teaming skills. • Should have good verbal and written communication skills. • High energy, proven dedication to achieving desired outcomes, and a positive attitude a must. |E-mail this position Submit Resume or C.V.2012-04-18 20:55:36United StatesSt. Jude MedicalTexasNMD3184TXDallas, TX27985018http://jobs.sjm.com/xml/27985018/jobUSADallasIntern: Scientific Literature Research Job Requisition #: NMD3173 Date Posted: 04/17/2012 Category: Clinical Research Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: Research, evaluate and interpret all available scientific literature relevant to various neuromodulation topics, while providing findings in a concise scientific report or presentation format. Assist in protocol development and data entry/evaluation for various pre-clinical/clinical neuromodulation projects. Other Duties: Participate in various meetings alongside the assigned supervisor in order to develop an understanding of the corporate aspects of the medical device industry. Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Performing thorough systematic literature evaluations (Research, evaluate and interpret all available and relevant scientific literature) and presenting findings in a report and presentation format. • Assist in drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Present findings on how the corporate structure of a medical device company works. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan. • This can be an Undergraduate, Graduate or PhD Program with an emphasis on biology/physiology/neuroscience. • Must have some experience with literature reviews. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:49:10United StatesSt. Jude MedicalTexasNMD3173TXDallas, TX27948961http://jobs.sjm.com/xml/27948961/jobUSADallasIntern: Engineering - Systems Integration and Verification Job Requisition #: NMD3174 Date Posted: 04/17/2012 Category: Software Engineering Systems Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: The intern will be tasked with evaluating and prototyping solutions for the Systems Integration and Systems Verification Teams. Specifically, evaluation and prototyping of solutions for the following areas will be the primary focus: • Porting of Manual tests into Automation System • Prototype Development of System Integration Test Cases (Automated Scripting) • Execution of existing Test Protocols (Dry-Run Testing) • Evaluation and/or Customization of a Continuous Integration Management Tool o (i.e. Hudson, AnthillPro, Electric Commander, etc.) Other Duties: The intern may also be asked to participate in other System Integration and Verification Activities such as: • Metrics and Dashboard Reporting and Publishing Tools o Interfacing to HP Quality Center, MS-Project, Spreadsheets, etc. • Peer Reviews of Test Cases • Code Reviews of Automation Software • Etc. Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Graduate or Undergraduate candidates in Computer Science, Software Engineering, Systems Engineering, Electrical Engineering or Computer Engineering. • Prefer candidates with experience in Software Testing, Systems Testing, or Continuous Integration. • Knowledge and experience in HP Quality Center, Labview and Continuous Integration tools is a plus. • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan. • This can be an Undergraduate, Graduate or PhD Program. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:49:01United StatesSt. Jude MedicalTexasNMD3174TXDallas, TX27948952http://jobs.sjm.com/xml/27948952/jobUSADallasIntern: Engineering - Mechanical Job Requisition #: NMD3175 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: • Setting up testing equipment/instrumentation in the Mechanical Engineering Lab • Performing mechanical testing and documenting results • Create prototypes for evaluation on Rapid Prototype machines • Shadowing design engineer on understanding of design principles, and concepts of Design • History File creation in the Product Development arena Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan. • This can be an Undergraduate, Graduate or PhD Program. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:59United StatesSt. Jude MedicalTexasNMD3175TXDallas, TX27948949http://jobs.sjm.com/xml/27948949/jobUSADallasIntern: Engineering - Product Development (Testing) Job Requisition #: NMD3176 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: • Write and execute engineering tests in C language for embedded systems, leveraging existing framework to accelerate test development Other Duties: • Roll-up test results into report and distribute via email Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan. • This can be an Undergraduate, Graduate or PhD Program. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. Education: • Coursework in C or C++ • Data Structures, desirable Other Desirable Skills: • Able to work independently, self-directed. • Enthusiasm to learn and to make and meet objectives, motivated, and a responsible team player, with good problem solving capabilities and good analytical skills. • Good verbal and written communication skills. • Work in a UNIX environment |E-mail this position Submit Resume or C.V.2012-04-17 18:48:10United StatesSt. Jude MedicalTexasNMD3176TXDallas, TX27948912http://jobs.sjm.com/xml/27948912/jobUSAIrvineProduct Development Engineer II Job Requisition #: AF13842 Date Posted: 04/17/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Product Development Engineer II to develop design concepts of disposable medical devices for the treatment of cardiac arrhythmias. The engineer will partner with other product development Engineers and perform the necessary developments and validations to advance the state of art designs of products requested from the customers. The engineer will create design history file documentation and write protocols and test reports for verification and validation testing. The engineer will also identify key design concepts for improving sub-assembly and final assembly of finished catheters. In addition, the engineer will assign prototyping and testing tasks to the R&D technicians to maintain continuous flow of product delivery to Advanced Manufacturing and Production. Impact this role will have within the AF division: • Communicates and demonstrates feasibility to customers and management focusing on treatment of cardiac arrhythmias. Evaluation of technologies should be based on the ability of the technology to provide a clinical utility to the user. • Independently focuses on design improvements having merit and meeting the robustness of design for manufacturability. • Maintains workflow with all of the necessary processes pertaining to Change Requests to effectively reduce multiple design changes that tend to slow the progression of each project. • Addresses issues and communicates with interdepartmental personnel to foster a complete understanding of the project scope and direction before releasing the design to the next responsible individual or department. • Identifies key attributes for advancing the state of the art of related products to the core business. Required Qualifications: • Requires Bachelor’s degree • 3+ years as a product development engineer with experience in all aspects of development activity of disposable medical devices • Demonstrated success in bringing new products from concept to market • Knowledge of design controls as well as FDA Quality System Requirements • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Bachelor’s degree in Mechanical Engineering • Familiar with ISO standards, GMP and GLP procedures. • Have high level understanding of design analysis and root cause failure analysis procedures for disposable catheters, preferably electrophysiology catheters. • Experience with design and processes involved in catheter manufacturing including extrusion and injection molding. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:09United StatesSt. Jude MedicalCaliforniaAF13842CAIrvine, CA27948908http://jobs.sjm.com/xml/27948908/jobUSADallasIntern: Engineering - Manufacturing Job Requisition #: NMD3181 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: The scope of the work will include: • Support manufacturing engineers in evaluation and optimization of existing manufacturing processes. • Support manufacturing engineers in evaluation of new manufacturing equipment and/or processes. This includes testing and data collection efforts to validate new manufacturing equipment and processes. • Assist in the development and optimizing of Work Design, Manufacturing Layout and Product Flow. Define and generate all required documentation in support of manufacturing protocols, reports, manufacturing instruction and procedures. • Support manufacturing engineering in continuous improvement initiatives. • Utilize basic statistical methods to support engineering testing. • Compare internal yield/external complaint failure model with the process FMEA and accurately assess quality impact. Other Duties: The general business activities that are vital but not typically taught including; documentation control systems, quality systems, device history records, design history records, material control systems. Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Enrolled in an Engineering degree program. (Manufacturing, Mechanical, Industrial, Biomedical). This can be an Undergraduate, Graduate or PhD Program. • A minimum GPA (documented) of 3.25 • Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict). • Computer literate • Statistical skills (basic and advanced statistics) • Knowledge of statistical software. • Technical writing skills • Verbal, written and presentation skills • Must be able to maintain regular attendance. • CAD experience • DOE, SPC, FMEA, GMP, FDA-QSR preferred |E-mail this position Submit Resume or C.V.2012-04-17 18:48:07United StatesSt. Jude MedicalTexasNMD3181TXDallas, TX27948906http://jobs.sjm.com/xml/27948906/jobUSADallasIntern: Engineering - Product Development (Testing) Job Requisition #: NMD3177 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: • Execution of existing test protocols (dry-run testing) • Writing of technical reports based on data from the execution of test protocols • Facilitating the review and release of reports and other documents Other Duties: • Installation, configuration, and streamlining the use of, various engineering tools • Creation/automation of custom reports, dashboards, and scorecards to provide near real-time status of EE activities • Code reviews of test software Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan. • This can be an Undergraduate, Graduate or PhD Program. • Graduate or Undergraduate candidates in Electrical Engineering, Systems Engineering, Computer Engineering, Software Engineering, or Computer Science. • Prefer candidates with experience in electrical hardware, systems and software testing. • Knowledge and experience with Subversion and MantisBT is a plus. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:05United StatesSt. Jude MedicalTexasNMD3177TXDallas, TX27948902http://jobs.sjm.com/xml/27948902/jobUSADallasIntern: Program Management Office Job Requisition #: NMD3178 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: • Create and maintain project schedules and Gantt charts using MS Project under the direction of a Program Manager • Update PMO SharePoint and program dashboards • Edit presentations using PowerPoint for Program Reviews • Maintain action registers and capture meeting minutes • Track resource assignment across projects and update staff allocation database • Collect updates from Program Managers and prepare project reports • Track equipment allocation and inventory • Participate in various project management activities Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan in Engineering. • This can be an Undergraduate, Graduate or PhD Program. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:04United StatesSt. Jude MedicalTexasNMD3178TXDallas, TX27948898http://jobs.sjm.com/xml/27948898/jobUSADallasIntern: Program Management Office Job Requisition #: NMD3179 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: • Create and maintain project schedules and Gantt charts using MS Project under the direction of a Program Manager • Update PMO SharePoint and program dashboards • Edit presentations using PowerPoint for Program Reviews • Maintain action registers and capture meeting minutes • Track resource assignment across projects and update staff allocation database • Collect updates from Program Managers and prepare project reports • Track equipment allocation and inventory • Participate in various project management activities Accountability/Supervision: Supervision: • Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. • The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. • Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: • Drawing basic conclusions from data and utilizing the information to make recommendations. • Volunteering ideas, asking questions, and responding promptly to information requests. • Completing reports and making presentations. Minimum Requirements/Qualifications: • Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan in Engineering. • This can be an Undergraduate, Graduate or PhD Program. • Required to work cooperatively and productively with others. • Demonstrated organizational skills and attentiveness to detail is required. • The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. • Must be able to maintain regular attendance. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:04United StatesSt. Jude MedicalTexasNMD3179TXDallas, TX27948897http://jobs.sjm.com/xml/27948897/jobUSADallasIntern: Engineering - Advanced Process Development Job Requisition #: NMD3180 Date Posted: 04/17/2012 Category: Engineering Internship Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: The Internship Program provides full-time practical work experience on a short-term temporary basis relevant to student’s academic programs while meeting the needs of the organization for relevant technical support. Using established concepts, knowledge and procedures, performs assignment of various scope and complexity, developing/implementing solutions for routine to complex problems. Essential Duties and Responsibilities: The intern will be tasked with performing engineering studies on process/product improvements related to neuromodulation devices and assemblies. The activities will provide the intern the opportunity to learn and utilize key engineering skills including; design of experiments (DOE), statistical process control (SPC), statistical analysis and report writing. Development of test methods will challenge the intern’s problem solving skills and providing clear documentation of results will help to develop communication skills. Other Duties: The general business activities that are vital but not typically taught including; documentation control systems, quality systems, device history records, design history records, material control systems. Accountability/Supervision: Supervision: Working under close, immediate and direct supervision on defined work assignments and/or usually following established procedures and manuals. The Internship program provides students the opportunity to work in a corporate environment while being treated as a professional with responsibilities and accountability. Work is reviewed in progress for soundness of judgment and overall accuracy. Accountability for: Drawing basic conclusions from data and utilizing the information to make recommendations. Volunteering ideas, asking questions, and responding promptly to information requests. Completing reports and making presentations. Minimum Requirements/Qualifications: Must be currently enrolled as a full-time student at a recognized college or university, with a defined degree plan in Engineering. This can be an Undergraduate, Graduate or PhD Program. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating procedures, processes, policies and rules is required. Must be able to maintain regular attendance. Education focus should be engineering-oriented. Desired skills would include proficiency in: Solid Works, Excel, Word and PowerPoint |E-mail this position Submit Resume or C.V.2012-04-17 18:48:04United StatesSt. Jude MedicalTexasNMD3180TXDallas, TX27948896http://jobs.sjm.com/xml/27948896/jobUSAMinnetonkaAccounts Payable Processor Job Requisition #: AF13840 Date Posted: 04/17/2012 Category: Accounting Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Accounts Payable Processor. The successful candidate will be responsible for processing payable invoices and check requests utilizing the SAP Accounts Payable system, ensuring all payments adhere to the SJM and AFD disbursement policies and maintaining accurate, timely A/P vendor files. Responsibilities also includes processing W-9’s for 1099's, Sales and Use Tax application, resolving discrepancies and assisting with processing the daily mail. Impact this role will have within the AF division: • Review invoices for mathematical accuracy and match units and prices to purchase order (manually or through P.O. system). Work with purchasing, receiving and vendors on discrepancies. • Review check requests for mathematical accuracy, proper support, authorization and general ledger coding. • Code payments and input into SAP accounts payable system, including proper general ledger account, due dates and computation of sales and use taxes when needed. • Research and resolve problems with invoices, receivers, purchase orders and uncashed A/P checks. • Respond to A/P related questions from employees, purchasing department and vendors. • Maintain the P.O. receipt account to insure old receipts are cleared. • Process payments and maintain records for sensitive items such as employee relocation costs and consulting agreements expeditiously and confidentially. • Other duties as assigned (sorting mail, scanning, invoice coding, etc.) Required Qualifications: • Two year degree in accounting is desirable with a minimum of four years of experience in accounts payable and an understanding of general accounting. Related work experience in high volume, large multi-location SAP environment. • Minimum two years experience with SAP • Prior experience processing W-9s, 1099's and sales and use taxes preferable. • Strong math and analytical skills and demonstrated capacity for accuracy while meeting deadlines. • Experience with automated accounting systems and personal computers required (SAP, Excel, Word). • Ability to interact with people at all levels of the organization, other external vendors and customers in a professional manner. • Ability to maintain confidentiality of sensitive information. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. |E-mail this position Submit Resume or C.V.2012-04-17 18:46:41United StatesSt. Jude MedicalMinnesotaAF13840MNMinnetonka, MN27948838http://jobs.sjm.com/xml/27948838/jobUSADallasSenior Clinical Research Associate Job Requisition #: NMD3166 Date Posted: 04/16/2012 Category: Clinical Nursing Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Plan, organize and coordinate clinical studies. Identifies, selects, initiates and closes-out appropriate study sites for clincial studies. Creates all study related documents including clinical study protocols, clincial final reports, informed consents, Case Report Forms, and other documents. Performs investigator training, site audits, and reports progress of the clinical studies. Assure study compliance to study protocol, Domestic and International Good Clinical Practices Guidelines and ANS Standard Operating Procedures. Major On-going Responsibilities: • Develops assigned investigational plans (including clinical protocol, case report forms, and all required documents) • Develop and coordinate IDE application submissions • May lead and direct the work of others/trains/mentors junior personnel • Implements clinical monitoring procedures from inception to end of clinical studies • Participates on multidisciplinary product/project teams • Conducts internal and external audits • Plans study budgets • Works with Clinical Operations on study site contracts/budgets • Train clinical site personnel and investigators • Assure study compliance and all safety information is reported appropriately • Maintain communication with sites • Present clinical study updates and summaries in written and oral reports • Assure accurate, complete and current records are maintained • Monitors (initiation, periodic and close-out visits) all clinical studies according to written GCPs and SOPs Experience and Training: • Bachelors degree in Nursing/Biology or Medical Field • 5+ years experience clinical monitoring • Trained in Good Clinical Practices • Implant device clinical monitoring experience desired • Previous experience using word processing, spreadsheet, data management software programs required • The individual must posess technical writing and fundamental problem solving skills • Individual must have project management skills • Individual must have the ability to travel Other Skills and Characteristics: • Candidate should possess good writing and communication skills • A demonstrated comfort using personal computers and the willingness to learn specific software applications are essential. • The individual should have a scientific/medical background, interest in research methology, the ability to work independently. • Relies on extensive experience and judgement to plan and accomplish goals • Performs a variety of tasks • The candidate should be innovative, people-oriented with good interaction skills. • May lead and direct the work of others • May train department personnel • May audit team work activities • A wide degree of creativity and latitude is expected. |E-mail this position Submit Resume or C.V.2012-04-16 18:49:44United StatesSt. Jude MedicalTexasNMD3166TXDallas, TX27925649http://jobs.sjm.com/xml/27925649/jobUSAWestfordEngineer - Manufacturing Job Requisition #: 12985 Date Posted: 04/16/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to operators and technicians. Additional responsibilities include: • Perform manufacturing non-conformance root cause analysis, generate non-conforming material reports and interact with the non-conforming material review board on regarding Laser Assembly Processes and components • Provide technical mentorship and support to operators • Conduct Process FMEAs and Process Validations • Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Work with Product Development to ensure Design for Manufacturability Individual should: • Be innovative, resourceful, and work with minimal direction • Have excellent organization, documentation, problem solving, communication, and teamwork skills • Work effectively with cross-functional teams Other Duties: List any other important but non-essential and/or infrequent duties performed. • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: Describe minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates, licenses, and/or registrations required. • BS, Electrical Engineering, Physics or Optics • 5+ years manufacturing engineering experience • Solid state laser development, manufacturing and/or tuning experience • Medical device experience preferred • Strong analytical, problem solving skills |E-mail this position Submit Resume or C.V.2012-04-16 18:44:39United StatesSt. Jude MedicalMassachusetts12985MAWestford, MA27925634http://jobs.sjm.com/xml/27925634/jobUSASylmarDevice Monitoring Representative Job Requisition #: 12929 Date Posted: 04/13/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under close and direct supervision on defined work assignments and/or usually following established procedures, answers technical and informational questions. Troubleshoots and resolves website problems and transmissions of patient data. Works in a call center work environment, exercising basic customer service skills in responding to remote patient monitoring inquiries from physicians, health care professionals, field staff, and patients. Responds accurately, promptly, and effectively to such inquiries and provides the basic clinical and technical interface between patients, the remote care medical community, and various Cardiac Rhythm Management Division (CRMD) departments. Proactively questions callers to identify and collect information to answer relatively complex inquiries regarding technical issues and/or complaints, as well as adverse events. Triages calls and may forward them to other CRMD personnel for further assistance when appropriate. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve website navigation and troubleshooting, patient transmitter set-up, and product information for remote care products; usually refers more complex problems to supervisor or more senior level personnel. Remains abreast of remote care advancements within SJM and industry. Routinely uses the most effective, cost efficient and best practices to execute processes. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of four or more years of progressively more responsible experience in a customer service, product support, IT, telecommunications or related role. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Demonstrated organizational skills, attentiveness to detail and the ability to work under close and direct supervision on defined work assignments is required. Incumbents are required to establish/maintain good working relationships and be able to work cooperatively and productively with others. Must be adept at handling multiple assignments in a timely manner while meeting assigned multiple projects/assignments. Must also have demonstrated verbal and written communication, interpersonal, facilitation, presentation, organizational, and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including spreadsheet, word processing, database management, and specialized applications. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. This position requires 24/hr., 7 day per week on-call availability. Desired Requirements: Fluently bilingual or multilingual in other languages is preferred. A healthcare, IT or telecommunications background is helpful. Experience in a technical support role to the medical device industry is preferred. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:53United StatesSt. Jude MedicalCalifornia12929CASylmar, CA27883027http://jobs.sjm.com/xml/27883027/jobUSANoneSr. Manufacturing Engineer Job Requisition #: 12977 Date Posted: 04/13/2012 Category: Engineering Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview With minimum supervision from direct supervisor, performs a variety of engineering assignments to meet quality standards in the most cost efficient manner. May supervise and provide technical assistance to exempt and non-exempt personnel. Will work closely with engineering and quality departments and have manufacturing responsibility for products at production level. Also will have the responsibility to qualify equipment or processes on replicated manufacturing lines. Responsible for the approval of procedures change request and qualifications documents. Many projects are broad in nature, the employee uses discretion to design project tasks to bring project to completion. Requirements/Education: Requirements include BS in Engineering, master degree is a plus. 5 years or more (internal and/or external in a related engineering role). Knowledge of FDA, GMP, and ISO guidelines is required. Strong statistical techniques knowledge (DOE, SPC) is required. PE license is a plus. Strong computer software knowledge (Microsoft Word, Excel, Power Point). Effective communication and presentation skills both in Spanish and English are required. Willing to travel and work under pressure. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:43United StatesSt. Jude MedicalNone12977NoneVirtual, USA27883014http://jobs.sjm.com/xml/27883014/jobUSANoneSenior Quality Engineer Job Requisition #: 12975 Date Posted: 04/13/2012 Category: Production Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview This position has a dual purpose (1) to ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing failures, complaints, defect reports, and audit findings in order to coordinate corrective action and (2) perform internal and vendor/supplier audits to determine such compliance. This position will have responsibility for quality compliance for all products produced in the SJM-PRLLC facility. This position works with minimum supervision and has appreciable latitude for interviewed actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion. Requirements/Education: Bachelors degree in Engineering required, advanced degree or process towards advanced degree is a plus. Must have 4+ years experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry. Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP, auditing principals, and contamination control. Prior experience auditing FDA regulations preferred. Must be bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines. Credentials of a Certified Quality Engineer are a plus. Must be able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:42United StatesSt. Jude MedicalNone12975NoneVirtual, USA27883013http://jobs.sjm.com/xml/27883013/jobUSAWestfordManager - Product Marketing Job Requisition #: 12964 Date Posted: 04/13/2012 Category: Marketing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Essential Tasks: •Supporting Responsibility for the following product platforms on the US market: RadiAnalyzer, RadiAnalyzer Xpress, Quantien, PressureWire Receiver, PW USB Receiver (Ilumien), AO USB Receiver (Ilumien), Wi-Box, RadiView software, PhysioMon software, Accessories and cables. Develop, execute and follow-up product launch plans. Including: Forecasting, Production coordination, Regulatory coordination, Sales personnel training, MarCom material development (in conjunction with USD/MN/Uppsala), Communication strategy (in conjunction with USD/MN/Uppsala) •Extensive field presence on the US market. Establish good contacts with professionals and users. •Take part of planning and execution of product line and product training efforts (courses, workshops, etc.). •Suggest pricing of product lines and individual products. •Monitor and document the market segments in terms of competition, price movements, sales arguments and market changes. •Effectively communicate gained knowledge within the organization. •Market requirements specifications (including requirements from end user and sales organization). •Make presentations to the USD Sales organization at product launches, meetings etc. •Monitor use and implementation of existing Marcom Material within the market place. Suggest additional developments. •Be an instrumental part in the product development process and make sure that the market needs will be reflected. •Other duties as required Education and/or Experience: Extended Cathlab experience. Technical or Clinical. Clinical Sales background. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:38United StatesSt. Jude MedicalMassachusetts12964MAWestford, MA27883010http://jobs.sjm.com/xml/27883010/jobUSAPortlandCost Accountant Manufacturing Job Requisition #: PDX1021 Date Posted: 04/13/2012 Category: Finance Location: Portland - OR - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The position functions a business partner and support for various financial matters such as budgeting, forecasting, product costing, manufacturing variances analysis & reporting, capital projects and other related financial requests. Assists the Controller in planning and execution the month-end closing activities for the respective business unit and accounts reconciliations. Major, On-Going Responsibilities: Oversees monthly closing for Accounting in SAP, including but not limited to review and approval of journal entries and preparation of inventory and other cost of goods sold schedules which are integral to the closing process. Oversees the financial management of Portland NMD inventories including monthly reconciliation, cycle count results, annual revaluation and reserve assessment for risk exposure. Ensures that Portland NMD maintains compliance with Sarbanes-Oxley procedures relating to inventory and cost accounting processes. Coordinates with Manufacturing the annual operating plan for Manufacturing, including updating elements of standard costed bills of materials. Provides detailed variance analysis, including material purchase price, production scrap, and cycle count. Coordinates the quarterly excess and obsolete inventory review process, working closely with Supply Chain. Financial representative on value stream teams, provide financial analysis and support to aid value stream team initiatives including cost and quality improvements. Skillful and safe operation of job-related equipment Effectively manage internal and external relationships of the job Ability to meet physical demands of job Regular and reliable attendance Compliance with all company policies Maintains inter-company transactions, reconciliations and relationships Requirements: Bachelors Degree in Accounting, Business Administration, or a related financial academic field. A minimum of five plus years of progressively more responsible accounting experience in a manufacturing environment. Must possess good detail orientation, excellent organizational and communication skills, familiarity with complex ERP accounting systems, preferrably SAP, exposure to internal and external audit requirements. Our work environment is fast-paced and dynamic. Good work ethic, flexibility, good judgment, and a positive and proactive attitude are important for a person to succeed. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:35United StatesSt. Jude MedicalOregonPDX1021ORPortland, OR27883003http://jobs.sjm.com/xml/27883003/jobUSAMinnetonkaSupervisor - Manufacturing Job Requisition #: 12994 Date Posted: 04/13/2012 Category: Manufacturing Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview This is a Second Shift position. Position Summary: This position will be responsible for driving the process of continuous improvement and lean principles. Responsibilities include shift performance with respect to safety, quality, on-time delivery and cost. Duties and Responsibilities: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements • Promote safety and ensure a safe work environment and safe work habits. • Maintain high level of visibility with production staff. Use hands-on approach to communicate daily and involve production staff in problem solving. • Develop a high performance work team with high levels of worker morale, satisfaction, and performance. • Create and maintain a respectful work environment by listening, seeking facts to support decisions, managing one's own reactions, and addressing unacceptable behavior. • Help production staff succeed through performance management. Provide coaching and performance communication to support development. • Review general status of production schedules to identify and resolve problems. • Ensure the desired product quality levels are achieved through use of standard work and training to those standards, training in operation and inspection techniques, and use of tools/data. • Support and implement new, customer-focused processes in accordance with lean principles and practices. Provide training and coaching to improve standard work, work center organization (5S), and housekeeping. Actively provide change leadership as required. • Support and foster an environment of continuous improvement by encouraging production staff to challenge existing processes and implement solutions that enhance the overall effectiveness of the operation. • Ensure adherence to all ISO and FDA quality regulations. • Support production staff in understanding company policies and practices. • Maintain time and production records. • Take notice of process related problems and support production staff in taking corrective action to improve the overall performance of the team. • Communicate with and listen to production staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc. • Communicate with other supervisors and appropriate personnel regarding equipment, safety, work center schedules, company policies and practices, performance improvement plans, etc. • Interview candidates for Value Stream and provide hiring decision for temp and regular positions. Qualifications: • 3 - 5 years of solid experience in a manufacturing operation. • Commitment to implementing and achieving safety, quality, customers service and cost goals by coaching and training associates. • Previous experience in a manufacturing operation with demonstrated ability to acquire and apply manufacturing principles a plus. • Demonstrated supervisory and coaching skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Excellent communication skills. • Demonstrated ability to work with and motivate people. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:34United StatesSt. Jude MedicalMinnesota12994MNMinnetonka, MN27883000http://jobs.sjm.com/xml/27883000/jobUSADallasHuman Resources Administrative Assistant II Job Requisition #: NMD3164 Date Posted: 04/13/2012 Category: Human Resources Administrative Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position provides administrative support to the Organizational Development / Human Respources Department. This position assists as directed in the administration of procedures and practices related to recruiting, organizational training and support of internal programs that focus on the development of NMD employees. Essential Functions: • Manage calendars & schedule meetings/interviews • Process invoices for payment, generate check requests for candidate travel & relocation, and track expenses • Support candidate relocation to include researching corporate housing availability, coordinating lease options, and managing lease transitions and invoicing • Support the contractor/consultant onboarding process • Generate monthly reports with key metrics for management • Support internal training class logistics to include manging scheduling, meeting room setup, food/beverage coordination and supporting presenter logistics. • Manage and maintain Orgainzational Chart • Support new hire onboarding and training intiatives • Support special projects and other administrative needs within Org. Dev. and HR. • Skillful and safe operation of job-related equipment [See Equipment Ability” below] • Effectively manage internal and external relationships of the job [See Relationships” below] • Ability to meet physical demands of job [See Physical Demands” below] • Regular and reliable attendance • Compliance with all company policies Other Functions and Duties: • Order and maintain supplies as needed • Perform other assigned functions as necessary to support department needs • Collaborate with other departmental contributors for the completion of routine assignments • Completes special projects and perform other duties as assigned by management Accountability/Supervision: • General supervision and instruction given for routine work and detailed instructions given for new activities or special assignments. Minimum Requirements/Qualifications: • High school diploma or other specialized training/equivalent related experience • Competence in English spelling, grammar and punctuation • Keyboard and computer skills and experience with Microsoft Office products to include Word, Excel, and Powerpoint Preferred Qualifications: • Three years of demonstrated experience providing administrative support in the HR/Organizational Development environment • Organizational skills, attention to detail and the ability to work under direct supervision • Ability to handle multiple projects in a timely manner • Interpersonal skills including the ability to listen, resolve problems and the ability to deal with unexpected problems and events while effectively communicating and maintaining rapport with other employees • The ability to use discretion in handling sensitive/confidential information • Strong customer service and communication skills Equipment/Tools Ability: In order to perform the essential functions of the job, this position requires the ability to safely and effectively operate/use the following equipment/tools: • Utilizes a personal computer and a variety of standard office equipment including telephone, copier, fax, etc. Relationships: • Internal: Contacts are frequently with individuals within own department, other departments, and occasionally outside own organization. Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature. Work Environment: • Works primarily in a standard office environment with air conditioning, good lighting, and moderate noise level. Physical Demands: Reasonable accommodations that do not impose an undue hardship will be made to allow individual to perform essential functions of the position. • In order to successfully perform the essential functions of the job, the employee is required to sit, stand, walk, and on occasion, travel. The employee may also be responsible for light lifting and handling of product items and office supplies, as well as using standard office equipment. Note: The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and requirements, which may change from time to time based on business needs. When appropriate, reasonable accommodations that do not impose an undue burden may be made to enable individuals with disabilities to perform the essential functions of the job. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:34United StatesSt. Jude MedicalTexasNMD3164TXDallas, TX27883002http://jobs.sjm.com/xml/27883002/jobUSAMinnetonkaSr. SAP Business Analyst - Mfg Job Requisition #: Corp 12029 Date Posted: 04/12/2012 Category: Information Technology Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview St. Jude Medical is continuing to work through a multi-year SAP implementation while adding new phases. The Sr. SAP Business Analyst – Manufacturing will lead functional aspects of projects to implement changes on behalf of the business. They will analyze and document business processes, define changes to business processes and assists in modifying them, configure, test and implement enterprise-wide business systems. Additionally, they will interview business partners to define detailed business requirements, map current processes to the desired state and identify gaps, such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls. Where appropriate, they will translate business requirements to functional specifications and technical requirements. They will also serves as the primary point of coordination and communication for a business domain to the business process owner and coordinate with business and technology teams to provision and test business systems to ensure they meet requirements. Job Duties: Collect and Document Requirements • Defines business needs by analyzing and documenting business processes; includes research, planning, writing user cases and project overviews, plus any supporting documentation • Gather requirements from customers to identify desired support needs • Scope the project and technical domain for the solution, based on data gathered • Prepare project and system related documentation consistent with standards and procedures outlined in the applicable development methodologies • Be responsible for understanding integration points within SAP and other systems/interfaces to fully grasp the impact of proposed system changes Defining Solutions • Perform feasibility studies and/or cost/benefit analyses in support of various initiatives • Maintain and document the logical and physical data models including data flow diagrams • Develop as-is and to-be business process flows and data models required by the department methodology for new system development or for process redesign • Identify areas for continuous improvement (CI) measures to reduce overall support requirements; implement CI measures within the L2 team, proactively • Be responsible for following all change control, validation, and operational procedures including all proper documentation for each procedure Serve as Interface between Business and Technical Teams • Understand the system interactions across the associated business domain and identify when business requirements complement/conflict with one another. Communicate the impacts of change in one system to other systems • Lead meetings in the business area to review business processes and identify information system requirements and/or needs • Understand the various business entities and cross divisional relationships • Serve as a liaison between IS and the supported business areas • Communicate effectively with management to enhance their understanding of the opportunities and limitations of information systems • Lead the day-to-day operations of the Level 2 SAP Operations support organization which includes employees and consultants. Provide input on performance and employment decisions Coordinate Execution of Initiatives • Coordinate support enhancements on large scale IT initiatives • Lead project teams consisting of intermediate and associate Business Analysts • Develop Test Plans, Cases, and Scripts and perform and coordinate Testing • Assist as requested in refining and updating existing service level agreements and specifications to ensure they reflect the needs of the broader SAP user base • Participate in the execution of post release Hypercare operations • Execute and measure Level 2 Operations team performance against a defined set of performance metrics • Develop and deliver end user training • Work on multiple projects at one time Other Duties • Serve as a business domain expert for the company, informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals • Provide updates and communication to customers, management and IT; escalate issues as appropriate • Provide management reporting for team goals, timelines and status • Act independently to determine methods and procedures on new or special assignments; may supervise the activities of others during special assignments • Other duties as assigned General Qualifications: • Bachelor’s Degree in Computer Science, MIS, and Mathematics, Engineering, Business or area of functional responsibility preferred, or equivalent 10 years of industry work experience • 8 years of industry experience in a technical profession • Minimum of five years’ experience in a lead role deploying ERP* Operations Functionality within Manufacturing including, master data, conversions, bill of materials, batch, serial numbers, etc. • Vast understanding of Planning and/or Manufacturing processes in an ERP* system • Ability to travel domestically and internationally 30 - 50% • Thorough knowledge of the integration of Master Data (Materials, Bills of Material, Routings, Work Centers) to successfully execute production in a regulated manufacturing environment • Proficiency with extraction and analysis of data from prior systems to load to current ERP* systems • Ability to translate complex business requirements into ERP* configuration and development solutions • Intimate knowledge of the integration points within ERP* systems • Experience in multiple full lifecycle ERP* implementations • Experience working in a broader enterprise/cross division business unit model • Ability to work in a highly matrix and geographically diverse business model • Ability to work effectively within a team and as an individual contributor in a fast paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner • Extremely strong verbal and written communications with ability to effectively communicate at multiple levels in the organization • Ability to recognize communications difficulties, diagnose the symptoms at the core, and work diplomatically to resolve them • Strong organizational, attention to detail and task follow-up skills • Adept at handling multiple assignments in a timely manner and meeting assigned deadlines *ERP preferred system is SAP |E-mail this position Submit Resume or C.V.2012-04-13 20:07:31United StatesSt. Jude MedicalMinnesotaCorp 12029MNMinnetonka, MN27882999http://jobs.sjm.com/xml/27882999/jobUSASunnyvaleRF Characterization Engineer Job Requisition #: 12377 Date Posted: 04/13/2012 Category: Electrical Engineering Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a hands-on technical RF Characterization Engineer to work on RF characterization from IC to system level on implantable biomedical products. These implantable pacemakers and implantable defibrillators save lives and provide therapy for serious medical conditions. Our devices are complex, low-power, embedded systems and include custom analog, digital, and mixed signal ICs, hybrids, and discrete components. The successful person in this role will have a good RF background with hands-on RF characterization experience and good breadth of electrical engineering knowledge. The RF Characterization Engineer will comprehensively analyze designs, create appropriate characterization test plans with rationale for choices, critically evaluate results, and trouble-shoot through challenging problems. This person will also work closely with other cross-functional groups such as Design, ATE, Firmware, Clinical Systems, and Manufacturing. Required Skills: • MSEE with at least 2 years RF systems experience or BSEE with at least 3 years RF systems experience • Theoretical and practical understanding of RF at system level • Hands on RF characterization including use of RF bench equipment • Strong technical analysis and troubleshooting skills for products containing RF, analog / digital ICs, discrete components, embedded systems • Excellent interpersonal and communication skills with ability to multi-task • Track record working collaboratively across functions in successful product development • Demonstrated ability to organize, analyze, document, prepare for characterization test plans, reviews, and reports • Ability to pick things up quickly • Motivated to learn about and ability to lead biomedical product development Desired Skills: • RF IC and RF Systems experience including ATE and bench equipment • Programming skills in C, LabWindows CVI |E-mail this position Submit Resume or C.V.2012-04-13 20:07:09United StatesSt. Jude MedicalCalifornia12377CASunnyvale, CA27882978http://jobs.sjm.com/xml/27882978/jobUSASunnyvaleMixed Signal IC Design Engineer Job Requisition #: 12378 Date Posted: 04/13/2012 Category: Electrical Engineering Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mixed Signal IC Design Engineer We are seeking a talented and versatile IC designer to be a part of our Integrated Circuit Development organization. Our team designs ultra-low power mixed-signal IC’s for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The successful person in this role will have a solid mastery of mixed-signal IC design, with breadth and depth of knowledge across digital and analog design. In this role, the engineer will work closely with other members of the Analog and Digital Design groups, and play a key role in growing our mixed-signal design, and system-on-a-chip development capability. Required Skills: - Solid background in analog IC design, knowledge of MOS device physics and design experience with common building blocks such as op amps, bias generators, bandgap references, switched capacitor circuits, etc. - Strong knowledge of simulation test bench development for mixed-signal (analog and digital) simulations, excellent simulation and debug skills, and working knowledge of mixed-signal testing. - Experience with Modelsim, NC-Verilog, VCS or similar digital logic simulators. - Experience with Verilog, C, and/or System Verilog. - Knowledge of the basic elements of writing synthesizable Verilog RTL code, including simple state machines, hardware register interfaces to an embedded MCU, and hierarchical design - Working knowledge of Matlab is desired. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements Education and Experience Requirements: BSEE or equivalent degree required, MSEE or equivalent preferred At least 6 years industry experience in IC design |E-mail this position Submit Resume or C.V.2012-04-13 20:07:09United StatesSt. Jude MedicalCalifornia12378CASunnyvale, CA27882979http://jobs.sjm.com/xml/27882979/jobUSASunnyvaleSenior RF Software/Hardware Engineer Job Requisition #: 12376 Date Posted: 04/13/2012 Category: Software Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a talented and versatile RF Engineer with strong software skills to be a part of our RF Telemetry Hardware organization. Our team is responsible for the RF hardware design for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The RF telemetry system provides a critical communication link between those implantable devices and external programmers and interrogators. The successful person in this role will have a strong background in firmware or software design, and a solid understanding of RF engineering. In this role, the engineer will work closely with other members of the RF and electrical system design groups, and play a key role in growing our RF telemetry capability. Responsibilities: - Software and Firmware design for RF hardware system design and characterization for implantable and external medical devices - Create software for RF system prototypes for output power measurements, optimization, tuning, sensitivity and parametric measurements. - RF laboratory measurements, including: o Measurement of small antenna performance in TEM cells o Evaluation of small inductive/magnetic loop antennas. - Develop, maintain, and support characterization firmware for use in RF system development - Interface with customers, vendors, and other department functions (manufacturing, mechanical designers, etc). Required Skills: - BSEE (MSEE preferred) and at least 5+ years of experience in software and/or firmware design, with a strong background in RF - Programming experience in C, C++, and LabWindows CVI - Firmware programming experience on embedded microcontrollers - Proven ability to develop structured, revision-controlled code used by various other groups/organizations - Excellent RF laboratory skills, including the use of spectrum analyzers, network analyzers, power meters, slide-screw tuners, test automation, etc. - Familiar with BER, polarization, free space loss, S-parameters, Smith Charts, and other RF measurements and performance metrics - Ability to grow and adapt to other work functions. - Capable of independent work as well as part of small teams. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements |E-mail this position Submit Resume or C.V.2012-04-13 20:07:08United StatesSt. Jude MedicalCalifornia12376CASunnyvale, CA27882976http://jobs.sjm.com/xml/27882976/jobUSAMaple GroveSr. Technician - R&D Job Requisition #: 12940 Date Posted: 04/12/2012 Category: Research Technician Location: Maple Grove - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Maple Grove. Job Overview Position Summary: Assist R&D engineers and/or teams in the development and analysis of products, materials, processes, or equipment. Essential Functions: • Coordinate and execute building of prototypes/products per engineering design and instructions. • Create fixtures for building and testing components and assembled products. • Develop test methods and create written test method documents. • Create and submit change requests into WindChill. • Use computers to operate various equipment and save data. • Test prototypes per engineering instructions and document test results. • Troubleshoot and suggest creative solutions to process, design, and testing issues. • Summarize and document test results. • Use internal and qualified external vendors to assist engineering teams to obtain supplies and services. • Support animal testing and clinical evaluations this includes working with animal tissue and animal blood. • Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Quality function. Qualifications: • Two year technical degree or equivalent experience • 5+ years experience • Mechanical aptitude • Experience developing and testing medical devices, preferably interventional cardiology devices or cardiac surgery devices • Prior experience in Nitinol and self expanding stent related technologies is required • Requires solid computer (e.g. Microsoft Office), data analysis and report writing skills • Strong manual dexterity and eye hand coordination • SolidWorks experience a plus |E-mail this position Submit Resume or C.V.2012-04-12 20:21:33United StatesSt. Jude MedicalMinnesota12940MNMaple Grove, MN27852718http://jobs.sjm.com/xml/27852718/jobUSAPlymouthClinical Program Budget Manager Job Requisition #: 12522 Date Posted: 04/12/2012 Category: Finance Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Program Budget Analyst will develop, analyze, and facilitate the execution of all Cardiovascular Clinical Affairs study budgets. This position will work with all clinical program managers and directors to ensure clinical trial financial forecasts are updated accurately and efficiently and are consistent with organizational objectives. RESPONSIBILITIES • Assists the Clinical Program Budget Manager in communicating budget timelines and preparing budgets for review • Negotiates changes to Clinical Trial site reimbursements and new site reimbursement agreements • Identifies and resolves budget and negotiation issues to a satisfactory conclusion meeting the needs of both clinical site customer and core business • Assists on monthly and quarterly direct clinical trial expense reporting, accruals and forecasting • Compiles negotiated cost history comparing the average, median, high, and lowest costs negotiated for each clinical trial • Inputs budget data into the company's budget templates and software system • Provides analysis to Clinical Program Budget Manager on each clinical trial budget and edits to budgets • Reviews budget data on a monthly and quarterly basis with clinical trial program managers • Assists Clinical management on budget planning related to Strategic planning • Works closely with the Finance department to ensure transparency and continuity of AOP budget data and monthly expense analysis • Follows Clinical operational processes in the preparation of clinical trial budgets • Ensures accuracy and completeness of the negotiated site reimbursements for the planning and tracking system • Tracks the negotiated budgets against the AOP plan REQUIREMENTS: • Bachelor’s degree in Finance or area of business management • 2-4 years experience in finance and contract negotiation • Experience negotiating corporate or customer contracts • Knowledge of financial tracking software • Highly proficient in MS Excel • Experience structuring and performing sophisticated financial projections and analyses • Experience managing time efficiently and handling multiple tasks • Ability to assimilate detailed information into the bigger picture • Excellent written and oral communication skills with small or large group audiences |E-mail this position Submit Resume or C.V.2012-04-12 20:21:17United StatesSt. Jude MedicalMinnesota12522MNPlymouth, MN27852714http://jobs.sjm.com/xml/27852714/jobUSASylmarTechnical Services Engineer Job Requisition #: 12932 Date Posted: 04/12/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, is primarily responsible for providing clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff. Provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments. •Lead several small teams in developing and testing technical tools and projects, including establishing ROI for projects, project plans, requirements, and test cases. •Provide cross-functional input to various product development teams on field issues and enhancement requests. •Attend advanced training sessions with product development engineering, then develop and present training for the RCTS team. Support questions from the team on an ongoing basis, as a subject matter expert on the remote care products, researching questions or testing behaviors, as needed. •Periodically travel to support customer programs. Requirements/Education: Bachelor of Science Degree in electronic engineering, biomedical engineering, or a related engineering field. A minimum of four plus years experience in a technical support role to the medical device industry, including relevant desired experience in the cardiac pacing industry. •Outstanding leadership skills, ideally with strong management potential. •Communication skills (i.e.: written, verbal, and through presentations). Versatility to be able to communicate effectively and patiently with management, elderly patients, clinicians, field personnel, and various technical and non-technical teams. •4 or more years of engineering experience. •Knowledge of databases would be a strength. •Experience in a cross-functional engineering role and/or a customer-facing role is preferred. •Excellent aptitude for learning complex systems, retaining information, and establishing creative troubleshooting techniques. |E-mail this position Submit Resume or C.V.2012-04-12 20:21:08United StatesSt. Jude MedicalCalifornia12932CASylmar, CA27852709http://jobs.sjm.com/xml/27852709/jobUSANoneTech Serv Specialist, EP Job Requisition #: USD 9548 Date Posted: 04/12/2012 Category: Clinical-Systems Engineering Location: Central - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Position located in Springfield, IL. Working under moderate direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving both AF and CRM products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Requirements/Education: Bachelors degree in Bio-Medical Engineering or related field required. Requires SJM Brady, Tachy, CRT, Ensite, and EP certification within 12 months of hire date. Requires HRS certification. A minimum of two plus years increasingly responsible experience in the cardiac pacing and related industries. Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol. Demonstrated advanced knowledge of cardiac pacing systems is also necessary. Must apply engineering skills and abilities to interpret and solve complex pacing ECGs. Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines. Must have the ability to concentrate on detail and work independently. Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively. Must possess comprehensive personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc., to develop presentation materials. Placement into this position requires written approval by the Area Vice President (AVP). |E-mail this position Submit Resume or C.V.2012-04-12 20:21:01United StatesSt. Jude MedicalNoneUSD 9548NoneVirtual, USA27852705http://jobs.sjm.com/xml/27852705/jobUSAWestfordSr Program Management Manager Job Requisition #: 12896 Date Posted: 04/12/2012 Category: Program Management Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Provides leadership to a cross-functional team to develop and execute plans for commercialization of new products. Works through the Product Development Process from product concept through commercialization. Works cross-functionally with core team and functional managers to ensure that projects meet objectives and timelines. Provides guidance to core team members to assist in resolving conflicts and clearing barriers to maintain effective and timely progress towards project completion. Represents the core team to the organization, and reports team progress, project recommendations and issue resolution at senior staff meetings. Maintains the overall project plan and schedule for the core team to ensure project meets divisional goals. Essential Functions: • Leadership and Accountability o Overall accountability for program execution, typically new product development programs o Report team progress and recommendations and resolution at senior staff meetings o Represents the entire product development team to the organization o Provide leadership to the team by working to define clear, realistic goals. Leads by example with excellent diligence, planning, analysis, and communication o Ensure that the cross functional members work as a "team" focused on divisional goals o Provide guidance to core team members on management techniques o Identify and help clear barriers to maintain effective and timely progress • Project Management o Delegate and manage the activities of the functional core team members o Develop a "general management" understanding of the skills and tasks associated with a particular function. The team leader is not expected to be an expert with respect to all functional skills. Core team members are expected to bring those skills o Core team members are expected to manage the efforts associated with their function if applicable. Core team leaders often manage the core team members at a higher level of detail but are expected to manage at the level that is necessary o Apply the appropriate management techniques given project specific needs, risks and differences in core team member skill levels o Resolve project resource issues, such as performance problems or availability problems o Take the lead in the development and maintenance of the project IBP and project planning o Facilitate all core team meetings. Issue agendas and minutes. Track progress against the project plan, business plan, project contract, and action items. o Resolve conflicts within and outside the team o Provide input into team member reviews • Communication o Communicate frequently with all levels of the organization o Communicate with PIB members to ensure that they understand the issues, recommendations, and plans. The team should factor PIB member and functional manager opinions and experiences into the development of their plans o Clarify options and solution recommendations off-line to ensure effective PIB reviews and decision making Qualifications: • 8-10 years experience in a regulated manufacturing environment • 10+ years of cross-functional Project Management experience • Can synthesize complex business and technical aspects of large scale development programs • Excellent understanding of all of the functional skills required for the project • A relatively deep understanding of each functional area • Excellent understanding of all of the functional skills required for the project • Very high respect of all team members and senior management • Proven core team/functional leader • Drives innovation and change • Takes initiative • Can navigate the entire organization • Proven ability to work outside of a division • Open communication with team, functional mgmt, and PIB members • Effectively clarify issues and actions • Very good skills and proven ability to manage to plan and resolve issues • Proven project planning skills • Undergraduate degree in mechanical, biology, biomedical or chemical engineering (minimum) • Advanced degree in business or technology may be applicable |E-mail this position Submit Resume or C.V.2012-04-12 20:19:37United StatesSt. Jude MedicalMassachusetts12896MAWestford, MA27852679http://jobs.sjm.com/xml/27852679/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12699 Date Posted: 04/11/2012 Category: Technical Services Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. Candidate that can work in a fast-paced environment, with attention to detail, meet deadlines, and has excellent organizational skills. Knowledge in FDA CDRH regulations a plus. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:32United StatesSt. Jude MedicalCalifornia12699CASunnyvale, CA27828034http://jobs.sjm.com/xml/27828034/jobUSASt. PaulTechnician - Manufacturing Job Requisition #: 12751 Date Posted: 03/27/2012 Category: Technician Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Essential Functions: •Identify, analyze, and implement manufacturing improvements (e.g., processes, yields, and productivity) •Test/troubleshoot manufacturing processes and equipment •Modify existing and develop new tooling and fixtures •Summarize, analyze, and provide recommendations from test results •Assist in writing technical reports by capturing experiemental results and demonstrating technical writing skills •Support new product introductions •Support process validation activities for continuing production and for new product introductions •Set-up production processes using established procedures and processes Qualifications: •2 year technical degree preferred •2+ years experience, preferably in medical device industry •Demonstrated experience in molding, tooling, troubleshooting equipment, and performing machine and process set-ups •Experience in GMP, ISO, and FDA controlled environments preferred •Proficient computer, data analysis and report writing skills |E-mail this position Submit Resume or C.V.2012-04-12 01:39:30United StatesSt. Jude MedicalMinnesota12751MNSt. Paul, MN27828027http://jobs.sjm.com/xml/27828027/jobUSASylmarEngineer, Principal Human Factors Design Job Requisition #: 12778 Date Posted: 04/10/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Engineer, Prin Human Fact Desi Summary Working independently without appreciable managerial oversight and direction, creates, develops, and leads teams that execute human factors engineering process for critically important products and product lines with the purpose of meeting divisional growth objectives. Plans, leads and conducts customer and competitive research to identify, prioritize/develop new projects, create detailed usability improvement plans, conceptual design, select/manage external usability design resources, and lead internal and external development resources to conduct customer usability research, conceptual design development, usability testing, interaction design and usability validation. In addition, is responsible for usability initiatives across product/organizational lines, and for training staff members about relevant usability theory, resources, and technology. Primarily supports one or multiple major programs and may advise other multiple efforts. Considered the Human Factors Departments technical product or protocol expert. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year or more of academic studies. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Applies advanced usability improvement principles to the evaluation and solution of complex product design problems. Remains abreast of and consults on usability improvement advancements. Creates and trains others in the use of the most effective, cost efficient and best usability related processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in the planning, organizing and performing work; monitors own and project teams performance and reports status to management and program team. Assures that quality of services meets or exceeds internal and external customer requirements. Qualifications Requirements/Education: Bachelors Degree in Psychology, Human Factors, Engineering, and Marketing, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience with the design of software for complex applications. Requirements include an in-depth knowledge and experience of: human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with research & development teams; customers, trends, governmental factors and emerging research and technologies affecting product usability. A qualified record of implementing new processes to existing human factors and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in human factors engineering, cognitive or experimental psychology, or in a field related to human-computer interaction. Experience with the cardiac pacing and defibrillation device market is also highly desirable. Academic or in-house courses in project management, leadership, training, continuous improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:25United StatesSt. Jude MedicalCalifornia12778CASylmar, CA27828017http://jobs.sjm.com/xml/27828017/jobUSASunnyvaleEngineer, Principal Human Factors Design Job Requisition #: 12779 Date Posted: 04/10/2012 Category: Engineering Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Engineer, Prin Human Fact Design Summary Working independently without appreciable managerial oversight and direction, creates, develops, and leads teams that execute human factors engineering process for critically important products and product lines with the purpose of meeting divisional growth objectives. Plans, leads and conducts customer and competitive research to identify, prioritize/develop new projects, create detailed usability improvement plans, conceptual design, select/manage external usability design resources, and lead internal and external development resources to conduct customer usability research, conceptual design development, usability testing, interaction design and usability validation. In addition, is responsible for usability initiatives across product/organizational lines, and for training staff members about relevant usability theory, resources, and technology. Primarily supports one or multiple major programs and may advise other multiple efforts. Considered the Human Factors Departments technical product or protocol expert. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year or more of academic studies. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Applies advanced usability improvement principles to the evaluation and solution of complex product design problems. Remains abreast of and consults on usability improvement advancements. Creates and trains others in the use of the most effective, cost efficient and best usability related processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in the planning, organizing and performing work; monitors own and project teams performance and reports status to management and program team. Assures that quality of services meets or exceeds internal and external customer requirements. Qualifications Requirements/Education: Bachelors Degree in Psychology, Human Factors, Engineering, and Marketing, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience with the design of software for complex applications. Requirements include an in-depth knowledge and experience of: human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with research & development teams; customers, trends, governmental factors and emerging research and technologies affecting product usability. A qualified record of implementing new processes to existing human factors and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in human factors engineering, cognitive or experimental psychology, or in a field related to human-computer interaction. Experience with the cardiac pacing and defibrillation device market is also highly desirable. Academic or in-house courses in project management, leadership, training, continuous improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:24United StatesSt. Jude MedicalCalifornia12779CASunnyvale, CA27828016http://jobs.sjm.com/xml/27828016/jobUSAMinnetonkaProduct Development Technician II Job Requisition #: CRT13049 Date Posted: 04/11/2012 Category: Technician Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Product Development Technician II to join our Minnetonka, MN based Cardiac Rhythm Management division. Within this role, the Product Development Technician II will help assist the product development teams in the development and analysis of products, materials, processes and equipment. Impacts this role will have within the CRM division: • Coordinate and execute building of prototypes/products per engineering design and instructions. • Create fixtures for building and testing components and assembled products. • Test prototypes per engineering instructions and document test results. • Troubleshoot and suggest creative solutions to process and design issues. • Summarize and document test results. • Use internal and qualified external vendors to assist engineering teams to obtain supplies and services. • Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the quality function. Required Qualifications: • Two year technical degree or equivalent. • 5+ years of medical device industry technician experience. • Experience with a variety of manufacturing processes. • Solid computer (e.g., CAD/Solidworks), data analysis and report writing skills. Preferred Qualifications: • Experience developing and testing medical devices, preferably interventional cardiology devices or cardiac surgery devices. To learn more, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:17United StatesSt. Jude MedicalMinnesotaCRT13049MNMinnetonka, MN27827988http://jobs.sjm.com/xml/27827988/jobUSASt. PaulProduct Manager, Heart Valves Job Requisition #: ID11735 Date Posted: 04/10/2012 Category: Marketing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN: Job Overview POSITION SUMMARY Identify, develop and execute Product Marketing commercialization plans for Mechanical and Tissue Heart Valve products sold globally. Act as a key interface between our International Customers, our geographic sales teams and the Product Division. Be responsible for the development of specific marketing plans and activities for specific products to establish, enhance or distinguish product placement within the competitive arena. Develop business plans and product positioning in the marketplace. Oversee market research, monitor competitive activity, and identify customer needs. Establish pricing strategies. Interface with engineering, manufacturing, and sales to develop new products or enhance existing products. TYPICAL DUTIES AND RESPONSIBILITIES •Plan and prepare product launches in cooperation with the Product Division /International Marketing and facilitate implementation throughout the geographies. •Evaluate strategies for product launches to ensure products are properly positioned and that brochures, sales sheets and supporting materials will launch products successfully and stimulate sales. •Develop recommendations on translating data collected on customer needs into engineering measures to evaluate product’s performance. •Develop recommendations on appropriate process for new products and on pricing and positioning strategies. •Prepare monthly new product launch updates for assigned products including metrics, strengths, gaps, strategies to close gaps, etc. •Provide analyses that highlight sales opportunities, trends and issues. •Provide rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal) •Contribute to the development of the International Division's annual strategic plan and operating plan •Develop marketing materials outside of new product launches •Develop obsolescence strategy to manage complete product portfolio •Represent the company by visiting accounts in order to solicit feedback on company products and services. •Develop appropriate strategies and plans in order to monitor and respond to changes in the market place, competitors, and performance versus objectives by major geography. •Work with the marketing manager to represent the Global viewpoint in the new product development process. •Determine clear and specific priorities for the development of new products and product enhancements by defining customer needs and working with other internal functional groups. •Rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal). •Contribute toward the development of an annual departmental budget by forecasting future needs, utilizing previous year’s budget, current objectives and budget guidelines. MINIMUM QUALIFICATIONS •Bachelors degree in business, sciences, or nursing required •5+ years marketing experience within Medical Device Industry including market plan development and execution, working effectively in a complex, multi-tasking environment •Previous experience managing multiple, simultaneous new product launches required •5+ years experience using spreadsheets, databases and presentation software •Strong oral and written communication skills, influence management skills and negotiation skills, while remaining sensitive to cultural differences •Strong analytical, strategic and problem-solving skills required •Strong individual self starter who has ability to develop and execute on plans •Strong conflict resolution skills to achieve results through cross functional groups •Strong team player—ability to work as a key member of the International Division marketing team. •Strong leadership skills—ability to function as the marketing lead” on high profile projects around the world •Project management skills—ability to manage complex projects and programs. Ability to pull the appropriate functional and geographic functions together to support initiatives •Ability to distinguish between Objectives, Strategies and Tactics •Knowledge/experience with customer base •Understanding of medical products clinical and regulatory process and environments PREFERRED QUALIFICATIONS •MBA with marketing emphasis preferred •5+ years marketing experience representing EP or Interventional Cardiology products •Previous experience collaborating with international marketing and sales teams TRAVEL REQUIREMENTS: •20-25% to international locations including Europe, Asia Pacific and Japan PHYSICAL DEMANDS/WORK ENVIRONMENT Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position requires significant travel to all international locations of St. Jude business interests outside of the US. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:14United StatesSt. Jude MedicalMinnesotaID11735MNSt. Paul, MN27827893http://jobs.sjm.com/xml/27827893/jobUSASylmarEngineer, Senior Hardware Design Job Requisition #: 12374 Date Posted: 04/11/2012 Category: Tachy Product Development Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview We are seeking a talented and versatile RF Engineer to be a part of our RF Telemetry Hardware organization. Our team is responsible for the RF hardware design for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The RF telemetry system provides a critical communication link between those implantable devices and external programmers and interrogators. The successful person in this role will have a solid mastery of RF engineering, with breadth and depth of knowledge across electrical design. In this role, the engineer will work closely with other members of the electrical system design groups, and play a key role in growing our RF telemetry capability. Responsibilities: - RF hardware system design for implantable medical devices - Create RF circuit prototypes for output power measurements, sensitivity and parametric measurements. - RF laboratory measurements, including: o Measurement of small antenna performance in TEM cells o Evaluation of small inductive/magnetic loop antennas. - Performing studies, RF modeling, simulation and other forms of analysis to predict component, interconnect, system and board level performance and to optimize design around complex requirements. - Refine and execute methodologies to carry designs into production. - Interface with vendors for the purchase, evaluation and testing of components. - Interface with customers, vendors, and other department functions (manufacturing, mechanical designers, etc). Required Skills: - BSEE (MSEE preferred) and at least 5+ years of experience in RF design - Thorough understanding of RF components such as dual directional couplers, splitters, programmable attenuators. - Excellent RF laboratory skills, including the use of spectrum analyzers, network analyzers, power meters, slide-screw tuners, test automation, etc. - Experience in antenna matching and matching network design for a miniaturized radio. - Familiar with Link Budget Analysis, BER, Polarization, free space loss, S-parameters, Smith Charts, Modulation standards and Noise figure calculations. - Ability to work with mixed signal domains in creating PCB and subassemblies for small production runs. - Ability to grow and adapt to other work functions. - Capable of independent work as well as part of small teams. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements Desired Skills: - Programming experience in C, C++, LabWindows CVI |E-mail this position Submit Resume or C.V.2012-04-12 01:38:38United StatesSt. Jude MedicalCalifornia12374CASylmar, CA27827376http://jobs.sjm.com/xml/27827376/jobUSASunnyvaleEngineering Group Leader Job Requisition #: 12375 Date Posted: 04/11/2012 Category: Tachy Product Development Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a hands-on highly technical Engineering Group Leader to directly work on and lead a small team of engineers on RF characterization from IC to system level on implantable biomedical products. These implantable pacemakers and implantable defibrillators save lives and provide therapy for serious medical conditions. Our devices are complex, low-power, embedded systems and include custom analog, digital, and mixed signal ICs, hybrids, and discrete components. The successful person in this role will have a strong RF background including hands-on RF characterization and leadership skills. The group lead will play a key role in growing our RF characterization capabilities and setting the example of comprehensive analysis of design, creation of appropriate characterization test plans with rationale for choices, critical evaluation of results, and trouble-shooting. This person will work closely with other cross-functional groups such as Design, ATE, Firmware, Clinical Systems, Manufacturing, and Program Management. Required Skills: • MSEE with at least 3 years or BSEE with at least 5 years of RF systems experience • Theoretical and practical understanding of RF at system level • Hands on RF characterization including use of RF bench equipment • Experience leading / mentoring engineers in RF characterization • Strong technical analysis and troubleshooting skills for products containing RF, analog / digital ICs, discrete components, embedded systems • Excellent interpersonal and communication skills with ability to multi-task • Track record working collaboratively across functions in successful product development • Demonstrated ability to organize, analyze, document, prepare for characterization test plans, reviews, and reports • Ability to pick things up quickly • Motivated to learn about and ability to lead biomedical product development • Recruiting and team building Desired Skills: • RF IC and RF Systems experience including ATE and bench equipment |E-mail this position Submit Resume or C.V.2012-04-12 01:38:12United StatesSt. Jude MedicalCalifornia12375CASunnyvale, CA27827357http://jobs.sjm.com/xml/27827357/jobUSASt. PaulSr Applied Research Software Eng Job Requisition #: AF13846 Date Posted: 04/09/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview St. Jude Medical, AF Division in St. Paul, MN seeks a Senior Applied Research Software Engineer to develop and implement advanced algorithms in Linux/UNIX and C/C++ for atrial fibrillation products and systems related to image processing and analysis. Provide support to port features from a research prototype platform to a commercialized product platform. Create custom software applications for preclinical research studies. Work closely with product development software engineers to specify and commercialize Applied Research Software features. Author and maintain design documentation and provide expertise and software development of GUI, OpenGL, algorithms and data processing. Requires Master’s degree in Computer Science & Engineering, plus at least two years or the full-time equivalent of two years (or at least 4000 total hours) of industry or graduate-level academic research experience as a research assistant or applied research software engineer researching, designing and implementing applied research algorithms for medical device products and systems related to image processing and analysis using Linux/UNIX, Microsoft Visual Studio, C/C++, GUI, OOD,VTK, Open GL, DICOM, FLTK and Software Version Control Software. Experience may be gained concurrently. Submit resumes online at www.sjm.com, requisition number AF13846. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:57United StatesSt. Jude MedicalMinnesotaAF13846MNSt. Paul, MN27772906http://jobs.sjm.com/xml/27772906/jobUSASylmarManager, Senior Product Launch Job Requisition #: 12759 Date Posted: 04/09/2012 Category: Marketing Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mgr, Sr Product Launch Summary Acting independently and within broad policy, has primary management responsibility for developing comprehensive and integrated portfolio and commercial launch strategies within core CRM markets and product segments. Responsible for developing, executing and managing implementation of product commercialization launch plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Troubleshoots complex problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Qualifications Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible experience in medical device or pharmaceutical marketing capacity, with an emphasis on full-cycle product launch activity and commercial execution. Requires demonstrated, meaningful experience in successful launch planning and execution, particularly with product platforms. Requires highly developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Must have the demonstrated ability to understand and comply with applicable regulatory and company operating procedures, processes, policies and rules. Must be able to work cooperatively and productively with others. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential. Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:54United StatesSt. Jude MedicalCalifornia12759CASylmar, CA27772905http://jobs.sjm.com/xml/27772905/jobUSASt. PaulSr. Telephony Engineer Job Requisition #: Corp 12027 Date Posted: 04/09/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview Please note - this position could be located in St. Paul, MN; Dallas, TX; Austin, TX; or Irvine, CA, however there is no relocation assistance available. This senior position will be responsible for engineering enterprise scalable technology solutions and services offerings in the Telephony and Conferencing Services department. This individual requires proven technical engineering depth, hands on implementation and strong operational experience in a high growth and fast pace environment. Essential Functions: Following established policies and operating standards, as well as industry best practices, in providing telecommunication services: • Present technical information along with financial impacts to management and business clients to obtain approvals and funding for projects • Lead design and implementation of voice, video and conferencing hardware and software services including delegation of tasks to other project team members • Assist with telephony architectural direction and service roadmap creation • Document and maintains telephony standards documents (COE) • Maintain current state diagrams and documentation of telephony, video and conferencing systems • Perform preventative maintenance and security administration functions • Set service expectations for changes with vendors and coordinate delivery of their services • Be accountable and responsible for software and hardware updates of telecommunications, video and conferencing systems • Troubleshoot problems associated with services for clients. Work with users, vendors and other technical personnel to identify and resolve problems and malfunctions and perform repairs • Perform regular and periodic utilization and capacity planning analysis and reports • Maintain competency in related technologies, including operating systems, associated tools and sub-systems • Interface with others on system infrastructure problems, technical concerns, and financial issues • Provide 24x7 on-call support as part of rotating team coverage Qualifications Required: • Bachelor degree in Computer Science, Engineering or Telecommunications or 8+ years of equivalent network and telephony experience • 10+ years of information technology experience including at least 2 years or more of direct customer support • 5+ years of direct hands on experience administrating and installing Cisco CallManager, Cisco Unity Voicemail and Cisco IPCC Express • 5+ years of Cisco IOS experience, specifically regarding QoS and voice gateway configurations (MGCP, SIP, H.323) • Relevant certifications desired (CCVP, CCNP, CCIE - Preferred) • Excellent written and verbal communications skills • Demonstrated understanding of TDM and IP Telephony concepts, networking/distributed computing environment concepts; knowledge of and experience with principles of routing, client/server programming, and the design of consistent network-wide telephony system layouts • Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently • Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines • Ability to travel internationally, up to 10% |E-mail this position Submit Resume or C.V.2012-04-10 02:03:46United StatesSt. Jude MedicalMinnesotaCorp 12027MNSt. Paul, MN27772904http://jobs.sjm.com/xml/27772904/jobUSASylmarCo-op - Mechanical Engineering Student - July - Dec. Job Requisition #: 12785 Date Posted: 04/09/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Hardware Development Co-op Job Description - July through mid Dec. (Mechanical Engineering) The co-op program provides practical work knowledge and experience. This co-op engineering position will provide general support to product development in the design, development, testing and manufacturing phase. Co-ops will interface with Research and Development, Product Engineers, Quality Assurance, Regulatory Affairs and Program Managers. Learning experience includes: 1. Applying fundamental engineering principles to real world designs 2. Responsible for designing, fabricating and the assembling all forms of medical devices from initial concept to completion or modification and customization utilizing CAD software such as Pro/Engineer. 3. Designs and executes mechanical & electrical tests of ICDs and Pacers. Data collection and analysis, including writing engineering test procedures and reports. 4. Assist in managing engineering related issues and technical support at a production level. 5. Manage projects and communicate project status including formal presentation to the engineering and management community 6. Working with cross-functional team members to achieve organizational goals 7. Maintain accurate record-keeping of design and fabrication of devices, and prepare documentation such as operating instructions and project records and drawing revision control in a form of engineering change orders (ECO) utilizing product life management software such as Teamcenter. Skills and traits we typically look for, but are not limited to, include: 1) At least a junior level student in Mechanical Engineering or Biomedical Engineering. 2) Very familiar with computer aided design software such as Pro/Engineer or Solidworks. 3) Familiar with product life cycle programs (i.e. Teamcenter) a plus 4) Needs to know the basics of Word, Excel, and PowerPoint 5) Knowledge of drafting techniques and tool design 6) Excellent communication and teamwork skills for working will all levels of employment and outside vendors 7) Ambitious and willing to learn new things; Not afraid of new challenges 8) Ability to multi-task and switch to higher priority tasks with little notice 9) Knowledge of how to apply basic engineering principles to product and/or component specifications. Details: Bachelor's Students - 18/hr Master's Students - 22/hr PhD Students - 25/hr We provide full housing and travel reimbursement. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:43United StatesSt. Jude MedicalCalifornia12785CASylmar, CA27772893http://jobs.sjm.com/xml/27772893/jobUSAMinnetonkaDeskside Technician Job Requisition #: AF13844 Date Posted: 04/09/2012 Category: Information Technology Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Deskside Technician. The successful candidate will, under general supervision and in accordance with technology standards, deploy and support desktop operating systems, applications, software, and end user hardware applications across all AFD locations in the Twin Cities. This individual will be required to accomplish tasks reliably, dependably, and on schedule. Impacts this role will have: • Configure and install new and existing PCs in a Windows based network environment. Work with client images for deployment of operating systems to desktops. Deploy and support applications, software, and end user hardware. Support LAN connectivity from the workstation to the network switch for all client end points .Provide level 1-2 break-fix analysis of both hardware and software issues on all client processing platforms. • Effectively manage service requests using the incident management application. Prioritize and execute tasks under high pressure circumstances, with guidance from supervisor. • Create and maintain documentation on procedures as required. • Assist in testing of updates within defined change control processes. • Other duties as required Qualifications: • 1-3 years related IT support experience and solid understanding of standard PC hardware required. • Experience with various makes and models of PC's, and all related peripherals. • Demonstrated technical aptitude and troubleshooting skills. • Proficient in support of current Windows operating systems and Office applications. • Solid communication and customer service skills, including ability to communicate effectively with both technical and non-technical individuals. • Ability to lift a minimum of 50 pounds, and travel between buildings within the Twin Cities. • Ability to provide occasional after-hours support when necessary Preferred Qualifications: • AS or BS in a related field and certification in Microsoft Desktop Support Series (MCAS or MOS) or equivalent. • Experience in medical device manufacturing processes and clean room environments a plus. • Any technical Microsoft certifications a plus. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:33United StatesSt. Jude MedicalMinnesotaAF13844MNMinnetonka, MN27772881http://jobs.sjm.com/xml/27772881/jobUSAWestfordSupervisor - Medical Device - 2nd Shift Job Requisition #: 12906 Date Posted: 04/09/2012 Category: Manufacturing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Medical device experience preferred. This 2nd shift position will be responsible for driving the process of continuous improvement and lean principles. They are responsible for their shifts' performance with respect to safety, quality, on-time delivery and cost. Essential Functions: • Accountable for shift's safety, quality, on-time delivery, and cost performance. • Drive continuous improvement efforts to improve metric performance. • Promote safety and ensure a safe work environment and safe work habits. • Maintain high level of visibility with production staff. Use hands-on approach to communicate daily and involve production staff in problem solving. • Develop a high performance work team with high levels of worker morale, satisfaction, and performance. • Create and maintain a respectful work environment by listening, seeking facts to support decisions, managing one's own reactions, and addressing unacceptable behavior. • Help production staff succeed through performance management. Provide coaching and performance communication to support development. • Review general status of production schedules to identify and resolve problems. • Ensure the desired product quality levels are achieved through use of standard work and training to those standards, training in operation and inspection techniques, and use of tools/data. • Support and implement new, customer-focused processes in accordance with lean principles and practices. Provide training and coaching to improve standard work, work center organization (5S), and housekeeping. Actively provide change leadership as required. • Support and foster an environment of continuous improvement by encouraging production staff to challenge existing processes and implement solutions that enhance the overall effectiveness of the operation. • Ensure adherence to all ISO and FDA quality regulations. • Support production staff in understanding company policies and practices. • Maintain time and production records. • Take notice of process related problems and support production staff in taking corrective action to improve the overall performance of the team. • Communicate with and listen to production staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc. • Communicate with other supervisors and appropriate personnel regarding equipment, safety, work center schedules, company policies and practices, performance improvement plans, etc. • Visionary in long range value stream strategy • Contribute to annual budgeting process • Identify, pursue and implement system/operational level improvements • Drive culture changes with initiatives such as 5S, SMED, OEE, OLE and DMAIC • Interview candidates for Value Stream and provide hiring decision for temp and regular positions. Accountability/Supervision: Assignments are received in task oriented terms. Provides direction to subordinates using established policies and precedents. Work is reviewed for soundness of judgment and overall quality and efficiency. Qualifications: • 5 -7 years of solid experience in a manufacturing operation. • B.A or B.S. degree preferred. • Commitment to implementing and achieving safety, quality, customers service and cost goals by coaching and training associates. • Previous experience in a manufacturing operation with demonstrated ability to acquire and apply manufacturing principles a plus. • Demonstrated coaching skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Excellent communication skills. • Demonstrated ability to work with and motivate people. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:03United StatesSt. Jude MedicalMassachusetts12906MAWestford, MA27772867http://jobs.sjm.com/xml/27772867/jobUSASt. PaulWeb Lead Job Requisition #: Corp 12020 Date Posted: 03/22/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview This Web Lead position works directly with the project managers, business analysts, internal business customers and infrastructure groups as needed to design, document, build and test information delivery solutions. They are responsible for creating, maintaining and executing team processes, standards and production delivery. Additionally, their responsibilities include reviewing and overseeing existing processes to ensure St. Jude Medical aligns with industry best practices, creating and maintaining team processes, and development and support standards for their environment. Job Duties: • Oversees software design specifications which meet all the business requirements, utilizing the appropriate notations and templates • Provide technical leadership in developing service applications and analyzing business requirements • Participates and/or facilitates in the requirement specification process for new software functionality to ensure that definitions of new functionality are clearly defined, fully understood and deliverable • Collaborates with team business analysts to determine appropriate software capabilities, functionality and design options • Performs peer reviews to ensure designs are consistent with organizational development standards and align with industry guidelines/best practices • Participates in creation of testing plans and in the execution of test cases. May develop the testing and validation of new software or enhancements to ensure software changes meet functional requirements • Participates in and oversees the design, development and testing of complex enhancements spanning multiple applications • Evaluates new technologies and provide assessments, presentations and recommendations on overall fit into SJM’s environment and strategy • Participates in developing and maintaining the roadmap for technology tools and environments • Provides post-production application support as required. Responsibilities may include consultation, problem identification, data analysis, and / or emergency repairs; requirements for support could entail a rotating 24x7x365 shift coverage • Assists in providing technical expertise in evaluating and determining what new technologies will work within current and future product delivery environments • Other duties as assigned Qualifications: • Bachelor’s degree in computers, business, or related field or a minimum of 15 years related technology experience. Master’s degree preferred • Ability to produce clear technical documentation and oversee technical review processes • Ability to help customers understand capabilities and translate requirements into solutions that are practical to implementation, robust and scalable • Oversees and reviews technical documentation and review processes • Ability to provide support on a rotating 24x7x365 shift • Ability to work in a highly matrix and geographically diverse business model • Ability to work effectively within a team and as an individual contributor in a fast paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner • Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization • Strong organizational, attention to detail and task follow-up skills • Adept at handling multiple assignments in a timely manner and meeting assigned deadlines • Experience working in a broader enterprise/cross division business unit model • Strong technical, analytical, and problem-solving skills Technical Qualifications: • 10 years’ experience with the broad spectrum of software delivery lifecycle activities including analysis, design, development, implementation and support • 9 years’ experience with complete solution deliver working with the following platforms o HTML with CSS layouts in web standard based approach for cross browser compatibility o JavaScript, Query, and client side AJAX functionality o SQL Server, SQL queries, stored procedures and XML o Microsoft Web Platform - ASP.NET, ADO.NET and general .NET framework • 9 years’ experience with software configuration management and release management • 7 years’ experience with system solution architecture (hardware, software, process, and people) • 5 years of experience delivering web content management based solutions o Data Templates and Content Hierarchy for a multi-site environment o Content controls and interactive forms o Page layouts with multi-lingual and multi-device rendering • 4 years’ experience as a team leads or line manager. Previous experience with performance management, employee selection and budget management preferred • 4 years experience running an on call production support operation |E-mail this position Submit Resume or C.V.2012-04-10 02:02:45United StatesSt. Jude MedicalMinnesotaCorp 12020MNSt. Paul, MN27772865http://jobs.sjm.com/xml/27772865/jobUSANoneField Clinical Engineer Job Requisition #: USD 9558 Date Posted: 04/09/2012 Category: Engineering Location: West Coast - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under general supervision, The Field Clinical Engineer (FCE) is responsible for supporting the EP-Workmate System sales and marketing process, by providing clinical consultation, teaching and support on the use of the EP-Workmate System and its appropriate application in the clinical setting. Provides field support for clinical studies programs, accurate technical support/ troubleshooting, and strategic collaboration with Sales to develop business in the local territory. Works within a small team atmosphere, including Sales Reps and their respective Regional Management, to develop individual account and territory sales strategies; Performs training and other related logistics coordination and gathers market/customer related feedback to ensure annual operating objectives attained. The FCE participates in the sales and marketing process and is responsible for ensuring all new accounts are established in accordance with St. Judes AF Divisions educational and in-service specific objectives and that ongoing product utilization is encouraged when necessary or requested through in-lab support and consultation with the EP and other lab support personnel. Requirements/Education: Bachelors Degree in Nursing, Engineering, Biological Sciences, a related field, or equivalent. Typically a minimum of three plus years of progressively more responsible relevant clinical work experience in cardiology, electro-physiology, or working with implantable ICDs, pacemakers, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol. Experience with programmable medical devices and software-based electrophysiology medical systems preferred. Must have demonstrated personal computer skills and be able to perform word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management, and customers. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Documented record of delivering research information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional Health Science certification or designation. |E-mail this position Submit Resume or C.V.2012-04-10 02:02:44United StatesSt. Jude MedicalNoneUSD 9558NoneVirtual, USA27772859http://jobs.sjm.com/xml/27772859/jobUSASt. PaulLabeling Coordinator I Job Requisition #: AF13828 Date Posted: 04/06/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Labeling Coordinator I to join our St Paul, Minnesota team. Within this role, the Labeling Coordinator will assist in the creation, revision and proofreading of product labeling components (Labels, IFUs, inserts). Initiates and coordinates the processing of change requests to labeling components to assure timely completion. Assures the labeling components (IFUs and associated product labeling) conform to the style, formatting and content required in SJM standards, worldwide standards and regulations for product labeling. Impact this role will have within the AF division: • Using standard operating procedures, create, edit and maintain product labeling in compliance to applicable regulations and standards. This includes all labels on product packaging including boxes, pouches and inserts shipped with the product. • Create and coordinate change orders with Document Control, and ensure that documentation is compliant with FDA and ISO regulations. • Minor editing and maintenance of instructions for Use (IFU or product manuals) and product labeling with guidance from Manager and Labeling Specialist. • Coordinate with external suppliers as required on labeling changes and translations. • Assist in the creation, editing and maintenance of labeling procedures to assure compliance to regulations worldwide such as 21 CFR 801 & 820, ISO 13485, Canada Food and Drugs Act Sections 21 - 23, TGA, etc. • Research and evaluate new documentation tools and methods; document and improve documentation processes. • Other duties as required. Required Qualifications: • Associates degree. • 1+ years’ experience working with product labeling, and electronically creating and managing change requests. • Ability to work on multiple projects. • Strong written and oral communication. • Teamwork, diligence, purposefulness, focus and persistence. • Experience working with Microsoft Word and Excel. • Capacity to learn new software applications as required. • Ability to work with limited day-to-day supervision. Preferred Qualifications: • SAP. • Working with product labeling in a FDA regulated environment. • Advanced user of Microsoft Word and Excel. • Strong understanding of FDA and ISO quality system requirements. • Demonstrated medical device industry experience. • Strong product technical skills. To learn more, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.2012-04-06 20:16:13United StatesSt. Jude MedicalMinnesotaAF13828MNSt. Paul, MN27704526http://jobs.sjm.com/xml/27704526/jobUSASt. PaulSenior Product Labeling Specialist Job Requisition #: AF13843 Date Posted: 04/06/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Senior Labeling Specialist to provide product labeling expertise and consultation. Within this role, the Senior Labeling Specialist will oversee the maintenance of product labeling. Additional responsibilities will include collaboration with the Regulatory, Marketing, Product Development and Documentation departments, developing and maintaining IFU (Manuals), associated product labeling, matching the style and formatting of SJM standards for product labeling and maintaining compliance of the labeling to applicable worldwide standards and regulations. Impact this role will have within the AF division: • Working under general supervision, the individual plans and provides project management (schedule, deadlines, risk assessment and resolution plans) on assigned projects and assigns task deliverables to Labeling Coordinators. • Edit and maintain Instructions for Use (AKA IFU or product manuals) utilizing input from Regulatory, Marketing, and Product Development departments. • Maintain product labeling in compliance to applicable regulations and standards. This includes all labels on product packaging including boxes, pouches and inserts shipped with the product. • Coordinate change orders with Document Control, and ensure that documentation is compliant with FDA and ISO regulations. • Coordinate with external suppliers as required on labeling changes and translations. • Edit and maintain labeling procedures to assure compliance to regulations worldwide such as 21 CFR 801 & 820, ISO 13485, Canada Food and Drugs Act Sections 21 - 23, TGA, etc. • Research and evaluate new documentation tools and methods; document and improve documentation processes. • Review marketing literature as required to assure claims are compliant with the IFU and labeling. Required Qualifications: • Associates Degree. • 5+ years quality and/or regulatory experience. • 3+ years experience working with product labeling, design dossiers, quality systems and/or regulatory labeling. • Excellent communication skills as recognized by team members and management. • Demonstrated project management skills to handle complex tasks with little or no direction. • Strong organizational skills with a detail orientation. • Skilled user of MS Word, MS Excel and/or MS Project. • Excellent reputation for building cross-functional relationships and groups. • Energized attitude to drive effective results, as recognized by peers and project team customers. • Strong product technical skills. • Strong understanding of FDA and ISO quality system requirements. • Engaged in ongoing professional development to grow and demonstrate technical skills. Preferred Qualifications: • BA, BS, Technical Communication or related field. • Demonstrated medical device industry experience is required. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.2012-04-06 20:16:11United StatesSt. Jude MedicalMinnesotaAF13843MNSt. Paul, MN27704525http://jobs.sjm.com/xml/27704525/jobUSAIrvineSenior Electrical Engineer Job Requisition #: AF13804 Date Posted: 04/05/2012 Category: Electrical Engineering Advanced Process Development Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview The Advanced Process Development-Systems (APDS) group in AFD-Irvine involves with new product development, product engineering support and develops processes and test systems for instrumentation manufacturing. We are seeking a talented, hands-on Senior Electrical Engineer to provide technical leadership on key projects, provide solutions that meet market and customer needs along with regulatory requirements. Plan, and organize engineering projects to meet company objectives for design, new product development and improvement of existing product lines – from project approval through volume production. Essential Functions: • Serve as technical leader for new product development and product improvement projects. • Provide in-depth analysis and innovative technical solutions. • Maintain and develop expertise on current technology, and apply technology to new product development. • Collaborate with PD (product development) Engineering, Manufacturing and other departments to provide design, development testing and deployment of projects. • Plan and organize projects to ensure timely and effective delivery into production and overall completion. • Manage multiple, parallel projects using formal project planning techniques. • Coordinate and lead project meetings with department representatives to ensure each project is meeting timeline. • Confer with project team members to address work procedure or project status questions, and resolve technical issues/complaints. Required Qualifications • BS in Electrical or Bioengineering and minimum 6 years relevant experience or MS in Electrical or Bioengineering and minimum 3 years relevant experience. • 5 or more years of direct experience in medical device industry. • Experienced in system design, embedded system design, analog and digital circuit design, embedded software. Knowledge of real time operating system. • Demonstrated strong technical and analytical/problem solving skills. • Write test protocols, reports and specifications. Perform bench and design V&V testing. • Experience with engineering change orders, documentation needs, protocol and report writing. Familiarity with d/pFMEA, DOE and QSR design control. • Strong verbal and written communication skills; ability to effectively communicate ideas to facilitate change at all levels of the organization. • Experienced with EE CAD tools. Preferred Qualifications • Adhere to medical device design control processes. Generate and maintain DHF (Design History File) during product development as required by project. • Experience with managing engineering projects and/or formal project management training • System architecture design experience. • Familiar with IEC standard; familiar with AAMI standards; familiar with system electrical safety requirements and EMI/EMC requirements. • Development of IQ/OQ/PQ protocols and reports for manufacturing equipment. • Experience with a variety of manufacturing processes • Experience using Lean Sigma or other Design for Manufacturability toolset required. • Review components for reliability, performance, and standardization. • Supplier technical capability reviews in partnership with supplier quality review. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction and quality improvements. • Ongoing support for component obsolescence. • Review engineering change orders. • Experience with LabView tools. |E-mail this position Submit Resume or C.V.2012-04-05 19:59:04United StatesSt. Jude MedicalCaliforniaAF13804CAIrvine, CA27668571http://jobs.sjm.com/xml/27668571/jobUSAWestfordTechnician - Quality Job Requisition #: 12659 Date Posted: 04/05/2012 Category: Quality Assurance Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for performing QA release of manufacturing related documentation in compliance to established requirements. Essential Functions: • Perform product documentation inspections against specification • Perform product documentation inspections against procedural and compliance requirements • Reconciliation of production data against documented nonconformances as appropriate • Issue nonconforming reports and assist in the resolution of nonconformances • Initiate related documentation changes • Collect data, summarize, analyze, perform basic statistical analysis on, and document results Qualifications: • High School degree required; 2 year technical degree preferred • 4 years minimum experience in manufacturing • 2 year experience in quality preferred • Strong understanding of manufacturing documentation (routing /travelers) and non conforming material reports • Knowledge of Quality Systems, FDA regulations and ISO 13485 • Good communication skills • Strong computer skills, including data analysis and report writing skills • Prior medical device experience a must |E-mail this position Submit Resume or C.V.2012-04-05 19:58:32United StatesSt. Jude MedicalMassachusetts12659MAWestford, MA27668551http://jobs.sjm.com/xml/27668551/jobUSAIrvineSenior Product Dvlpmnt Engineer Job Requisition #: AF13825 Date Posted: 04/05/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Develops new test methods and procedures for the characterization of early phase catheter design concepts, as well as device verification testing. • Leads in the development and validation of standardized variable data collection test methods in both discovery and design control environments • Collects, reduces, analyzes and presents empirically derived data using DOE, ANOVA and other statistical tools. • Assists the development of design performance simulation, both closed form & computer aided numerical modeling techniques. • Establishes the definition of material performance and defines the load case required, to understand and develop a match to clinical scenarios. Required Qualifications: • BS in Mechanical, Materials or Biomedical Engineering • 6+ years of product development (R&D) experience • Direct catheter experience. • Familiarity with CAD and FEA software (e.g. ProE, Abacus, ANSYS etc.). • Process development experience – process identification and process characterization. • Demonstrable experience using MiniTab statistical analysis software. • Demonstrated ability to lead technical projects meeting established deliverables. • Direct experience leading and/or performing failure analysis. • Effective communication skills and experience working with cross functional teams. • Excellent documentation writing skills; clear and concise using objective evidence and language. • Superior organizational skills including project management aptitude. • Energized attitude |E-mail this position Submit Resume or C.V.2012-04-05 19:58:22United StatesSt. Jude MedicalCaliforniaAF13825CAIrvine, CA27668542http://jobs.sjm.com/xml/27668542/jobUSAAustinSr. Commissions Analyst Job Requisition #: USD 9560 Date Posted: 04/05/2012 Category: Accounting Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working without appreciable supervision, leads in the development, implementation, execution and payment of USDs Sales Compensation Plans and related Employee Agreements. Prepares internal and external USD Compensation statements, supporting schedules, performs financial compensation and data review/analysis, assists in preparation/completion of accounting and compensation month-end closings, and assists in financial compensation reporting. Applies and shares advanced expertise in the analysis and review of sales and legal requirements for the purpose of executing commission and bonus payments. Initiates the planning, organizing, performing, coordinating and/or directing of sales compensation work, and may contribute to the performance evaluations of other department personnel. Remains abreast of and consults on Sales Compensation trends and financial standards. Possesses and exercises strong relational database management and organizational skills. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Assures the quality of services meets internal and external customer requirements. Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager. Leads in a team environment, and shares expertise on operational sales activities and related applications. Requirements/Education: 1.MBA and/or CPA Finance, Accounting, Business Administration or other related discipline. 2.Experience equivalent to seven (7) years in a Financial/Accounting/Sales Analyst role(s), and inclusive of experience in a Commission Accountant/Analyst role. 3.Relevant functional experience of five (7) years in Financial/Sales Reporting and Database Management modeling. 4.Must demonstrated advanced Excel/Access skills, the ability to interface data with new or existing software and/or applications, and prepare routine ad-hoc reports using SQL and other data mining tools. |E-mail this position Submit Resume or C.V.2012-04-05 19:58:03United StatesSt. Jude MedicalTexasUSD 9560TXAustin, TX27668525http://jobs.sjm.com/xml/27668525/jobUSASylmarSoftware Engineer I-Firmware Development Job Requisition #: 12770 Date Posted: 04/04/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview St. Jude Medical is seeking talented embedded software developers to join our Firmware Development organization. As a software engineer on our team, you'll work in a dynamic, collaborative environment to develop high quality embedded software for our implantable medical devices that operates within very tight constraints for memory footprint, power consumption, and real-time performance for our implantable medical devices, such as cardiac pacemakers and implantable cardioverter defibrillators. Responsibilities: • Design, develop, test, debug, and maintain firmware for implantable medical devices • Other duties as assigned Qualifications: • Excellent written and oral communication skills • Strong teamwork and leadership skills • Thorough understanding of the software development lifecycle • Knowledge of computer architecture • Ability to write clear, concise code that can be maintained by others • Strong C programming skills in RTOS environments • Experience with assembly programming • Experience using version control systems • Experience with logic analyzers and other lab bench test equipment. Relevant Coursework: • Software engineering • Software algorithms • Data structures • Operating systems • Computer architecture Education: • B.S. degree in computer science, computer engineering, or related fields. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:40United StatesSt. Jude MedicalCalifornia12770CASylmar, CA27644374http://jobs.sjm.com/xml/27644374/jobUSASunnyvaleEngineer I, Software Job Requisition #: 12774 Date Posted: 04/04/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs specialized level software project activities in such areas as Development Engineering, IT Engineering, System Engineering, Test Engineering, and/or related areas. Assignments may include, but are not limited to, analyzing requirements and providing strategic feedback, planning and scheduling data, updating and maintaining different software specifications based on analysis of specifications, needs and improvements, as well as troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code based on strategic analysis. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. • Exposure to writing requirements • Exposure to embedded software • Knowledge of basic electronics, hardware design, and cardiovascular physiology • Knowledge of pacemaker and/or ICD algorithms a plus • Experience with DOORS and ClearQuest a plus • Team leadership skills including, but not limited to, resource planning and employee mentorship a plus • Ability to comfortably work in an FDA-regulated environment as part of a team with clear, well-defined processes • Someone who is high-energy, enthusiastic, and looking to make a significant contribution to the organization • Someone who is extremely meticulous (detail-oriented) Requirements/Education: Bachelor of Science Degree in Computer Science Engineering or a related engineering field. A minimum of six months of relevant software engineering work experience on multiple platforms with varied programming methods is required. Requires demonstrated written and verbal communication, interpersonal, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Evaluation, originality, and/or ingenuity required. Desired Requirements: Relevant coursework and/or a demonstrated understanding of product development/clinical engineering concepts, theory, and applications are desired. Relevant coursework and/or a demonstrated understanding of cardiac electro-physiology. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing, as well as Regulatory Affairs is also desired. Previous experience in the implantable medical device industry is preferred. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:40United StatesSt. Jude MedicalCalifornia12774CASunnyvale, CA27644376http://jobs.sjm.com/xml/27644376/jobUSASunnyvaleSenior Software Verification Engineer (C++, C#) Job Requisition #: 12829 Date Posted: 04/04/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Please only apply if you have 5+ years software verification with C++ and C#. Stable work history is a must too. Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as SW Development and/or automated software Testing. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software test specifications or test libraries as well as the troubleshooting, debugging, and maintenance of software test code or test library code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs technical studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. A demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks is also required. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Required: Proficiency and/or work experience designing and implementing automated software testing is required. Proficiency and/or work experience in software utilizing a variety of programming languages such as C++, and/or C# are required. Strong written/verbal communication, analytical thinking, and problem solving skills are desired. Proficiency and/or work experience with object-oriented methodology including analysis, design, development, and structured software development is desired. Desired Requirements: An advanced credential in a relevant discipline/concentration. Specialized experience and/or relevant coursework related to the software applications, programs, and processes. Academic or in-house courses in project management, leadership, training, and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:13United StatesSt. Jude MedicalCalifornia12829CASunnyvale, CA27644368http://jobs.sjm.com/xml/27644368/jobUSASylmarEngineer, Senior Software Job Requisition #: 12712 Date Posted: 04/04/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as SW Development and/or automated software Testing. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software test specifications or test libraries as well as the troubleshooting, debugging, and maintenance of software test code or test library code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. Required: Proficiency and/or work experience designing and implementing automated software testing is required. Proficiency and/or work experience in software utilizing a variety of programming languages such as C++, and/or C# are required. Strong written/verbal communication, analytical thinking, and problem solving skills are desired. Proficiency and/or work experience with object-oriented methodology including analysis, design, development, and structured software development is desired. |E-mail this position Submit Resume or C.V.2012-04-04 19:59:57United StatesSt. Jude MedicalCalifornia12712CASylmar, CA27644364http://jobs.sjm.com/xml/27644364/jobUSASunnyvaleServer Administrator Job Requisition #: 12735 Date Posted: 04/04/2012 Category: Information Technology Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under general supervision, oversees and coordinates overall activities relating to the operation and maintenance of computer servers and the installation and configuration of new computer equipment. . Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. The position will also include support of Client PC’s, responsible for the installation, repair and preventative maintenance of personal computers (PCs), networks and related systems. Performs all installations, configurations, upgrades and backups of software (i.e., Microsoft Office, Windows OS) and hardware applications at end user locations. Troubleshoots software and hardware failures and identifies network problems when they relate to PCs. Qualifications: Requirements/Education: Requires a Bachelors Degree in Computer Science or equivalent. Typically a minimum of four years technical experience in computer maintenance and repair including at least two years direct experience in the systems management and administration of a medium to large computer server and client environments supporting at least 200 users. Formal training in computer systems management and administration is also required. Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently. Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MSCE). Specific Job Skill: Solid experience required with Windows OS, VMware, MS Applications, Software Deployment Tools, and Desktop troubleshooting tools. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, virtualization, network, storage/SAN, system backups, security, Client desktop support, Software deployment) This would also include training in deskside automation support and/or service. Must have demonstrated personal computer application (e.g., spreadsheet and word processing), installation and repair skills. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. The ability to work independently. The demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies and rules is essential. Must be able to operate in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Must be a team player with excellent oral and written communication skills. |E-mail this position Submit Resume or C.V.2012-04-04 19:59:50United StatesSt. Jude MedicalCalifornia12735CASunnyvale, CA27644362http://jobs.sjm.com/xml/27644362/jobUSADallasRegulatory Affairs Specialist Job Requisition #: NMD3160 Date Posted: 04/04/2012 Category: Regulatory Affairs Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview This position is responsible for developing international and domestic regulatory submission strategies. The Regulatory Affairs Specialist will prepare 510(k), PMA, and IDE submission documentation; prepare international regulatory filing and registration documentation; conduct device research to support regulatory submissions; review product/process, advertising and promotional material changes to determine regulatory compliance and submission implications; and participate on development and clinical trial teams. Major Ongoing Responsibilities: • Implementation of international and domestic regulatory strategies • Prepare 510 (k)'s PMA's and IDE's submission applications • Prepare design dossiers for review by notified body • Research current domestic and international regulations • Submit product registrations and applications to foreign governments as required (i.e. TGA). • Review and approve product changes in accordance with regulatory guidelines • Review and approve advertising and promotional materials for regulatory implications • Participate and contribute to project teams Experience and Training: • Bachelors degree in Biology/Biomedical Engineering or related field • 2-5 years experience in Regulatory Affairs and Quality Assurance required • Previous experience with PMA, 510(k), and IDE submissions required • Previous experience with implantable device submissions required • Previous experience with international regulatory submissions required • Previous experience using word processing, spreadsheet, data management software programs desired • Technical writing and fundamental problem solving skills required |E-mail this position Submit Resume or C.V.2012-04-04 19:59:50United StatesSt. Jude MedicalTexasNMD3160TXDallas, TX27644363http://jobs.sjm.com/xml/27644363/jobUSAMinnetonkaSr. SAP Project Manager Job Requisition #: Corp 12021 Date Posted: 03/26/2012 Category: Information Technology Project Management Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview This position has overall accountability and responsibility to plan and manage the resources, budget and processes used to develop and implement complex strategic enterprise projects including SAP implementations across St. Jude Medical. This role is directly responsible for successful delivery of large, global SJM IT projects. This role is the Enterprise IT point of contact for executive level business customers. This position is responsible for managing all project task activities and providing work direction to the staff assigned to the project. The position requires outstanding initiation, communication, and organizational skills, as well as the ability to create an effective team environment. A deep understanding of operations/ business challenges and the ability to translate them into solutions is critical. Job Duties: • Plan and manage execution of IT projects • Initial project investigations • Requirements definition • Scope definition and management • Schedule and tasks • Issues management • Quality and budget • Risk analysis and management • Contingency planning • Change management • Overall project control and coordination • Monitor and report of project status • Manage project teams • Define and manage team member roles and expectations • Build team relationship • Coach and train team members • Provide day-to-day work direction for project teams • Manage relationships • Identify and engage stakeholders • Develop and maintain outstanding customer service relationships • Conduct formal presentations to management • Execute and improve IT processes • Collaborate with other project managers to assure a consistent implementation of the St. Jude Medical applications, infrastructure and project management disciplines and methodologies • Determine methods and procedures on new assignments • Other duties as assigned Qualifications: • Bachelor's degree in Business, Computer Science or related field; MBA is a plus • Minimum of twelve years IT experience using a standard IT methodology, with a minimum of eight years in a project leadership role, performing project planning and implementation • Experience in at least 2 full project lifecycles of an SAP implementation • At least 4 years of experience in managing a team of 10+ full-time employees (FTEs) and external contractors • Proven experience managing projects and leading cross-functional remote teams • Proven experience managing and being accountable for large, global SAP ERP (or Equivalent) implementation projects • Self-motivated with excellent planning, interpersonal and organizational skills • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization • Understands the OCM (organizational change management) challenges associated with implementing a transformational project and effectively leads others through change and adoption • Ability to identify and resolve issues • Excellent logical, analytical, and problem solving skills • Ability to effectively work in a fast paced changing environment • Ability to work in a highly matrix and geographically diverse business model • Ability to travel domestically and/or internationally (up to 30% of the time) • Working knowledge of SAP ERP functionality/business processes including finance, sales and distribution and manufacturing • Experience with MS Project, Excel, Word and Visio • Experience working with international geographies a plus • Knowledge of the SAP ASAP Methodology preferred |E-mail this position Submit Resume or C.V.2012-04-04 00:04:07United StatesSt. Jude MedicalMinnesotaCorp 12021MNMinnetonka, MN27622893http://jobs.sjm.com/xml/27622893/jobUSASt. PaulPrincipal Quality Engineer Job Requisition #: 12790 Date Posted: 04/02/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview The Principal Quality Engineer is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within manufacturing and system/services support. Requirements: • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel • Leads multifunctional teams in completing program directed or continuous improvement activities • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 8+ years experience • Demonstrated supervisory experience • Engineering experience and demonstrated use of Quality tools/methodologies • Must have experience with commercializing / validating new products • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Demonstrates technical leadership within the department and outside the department • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-03 03:22:30United StatesSt. Jude MedicalMinnesota12790MNSt. Paul, MN27603034http://jobs.sjm.com/xml/27603034/jobUSAPlymouthMedical and Scientific Affairs Director Job Requisition #: 12819 Date Posted: 04/02/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview St. Jude Medical, Inc. Job Title: Director, Medical and Scientific Affairs Duties: Plan, direct, and coordinate medical and scientific activities related to clinical investigation and research. Determine scientific goals, and develop and implement policies and procedures for clinical scientific research to ensure regulatory and industry requirements. Oversee a research team engaged in a regulated industry clinical investigation and research, and serve as primary internal resource for medical and scientific guidance across current and future product lines. Applying highly developed management and leadership skills, manage medical and scientific team with primary purpose to provide in-depth medical and scientific support to company’s cross functional development and execution team; serve as medical resource to create and implement clinical trial strategies and methodologies to obtain market approval; develop and maintain standards of care relevant to industry products and patient population and disease pathologies of interest. Develop, implement, and oversee internal medical monitoring processes to include adverse event reporting and safety surveillance procedures. Provide oversight of independent committees including clinical events committees, and data safety monitoring procedures to ensure compliance with regulatory standards and FDS expectations; assist Business Development in strategic planning and due diligence activities; assist with development of educational materials, educational programs and participate in such. Job Requirements: M.D., or equivalent foreign degree as determined by a written evaluation, with at least six (6) years experience as clinical research scientist working with medical devices related to cardiology and cardiac procedures, including cardiac catherization, percutaneous coronary interventions, and cardiovascular/metabolism therapeutics. Experience must include designing and conducting multiple randomized, controlled clinical research trials using IND, NDA, IDE, and PMA submissions, and must include pharmamacovigilance with medical safety assessments, medical safety reports, and biocompatibility testing in compliance with CCP, ICH, and US FDA regulations. |E-mail this position Submit Resume or C.V.2012-04-03 03:22:11United StatesSt. Jude MedicalMinnesota12819MNPlymouth, MN27603030http://jobs.sjm.com/xml/27603030/jobUSAMinnetonkaSenior Assembler - 1st Shift Job Requisition #: AF13834 Date Posted: 04/02/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Senior Assembler of high-tech cardiovascular medical devices. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. Additionally, this position will act as back up to Group Leader. This is a 1st shift, Monday-Thursday opportunity. Impact this role will have within the AF division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Coordinates assigned jobs and activities, while including mentoring and cross training others on operation functions. • Train employees on processes (new processes and process changes). • Perform workstation, cell and/or machine setup, test and perform rework procedures. • Understands and accurately completes necessary paperwork. • Other duties as assigned, such as: including scheduling, updating metric boards, providing backup for the Group Leader and Supervisor. Required Qualifications: • High school diploma or equivalent. • 3+ years of assembly experience. • 2+ years of medical device industry assembly experience. • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Strong written and verbal communication skills. • Demonstrated ability to communicate and interact with others including, but not limited to Group Leads, Supervisors and Engineers. • Must be computer proficient. • Ability to troubleshoot and problem solve. • Understand lean principle concepts (CCDS – Certified Cardiac Device Specialist, 5S, Kaizen), and has the ability to identify and continually make suggestions for process improvements. • Must have a high level of attention to detail. • Demonstrated consistent attainment of established cycle times for all process steps within primary work cell. • Demonstrates a high sense of leadership and ownership in primary work cell. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time and detailed. • Energized attitude. |E-mail this position Submit Resume or C.V.2012-04-03 03:21:56United StatesSt. Jude MedicalMinnesotaAF13834MNMinnetonka, MN27603024http://jobs.sjm.com/xml/27603024/jobUSAPlymouthSpecialist - Regulatory Affairs Job Requisition #: 12900 Date Posted: 04/02/2012 Category: Regulatory Affairs Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Regulatory Affairs Specialist ensures products and procedures comply with regulatory agencies specifications. Responsibilities: • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals • Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada • Prepare appropriate documentation for renewing CE mark certification • Prepare appropriate documentation for annual renewals submitted to Health Canada • Prepare Technical Files for product s with self certified CE Marks • Update Technical Files on annual basis • Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations • Act as a core member on development teams, providing RA guidance, and project regulatory assessments • Work with Engineering teams (R&D, Quality, Design Assurance) to evaluate testing strategies • Interface directly with FDA, Notified Bodies and Health Canada • Communicate and coordinate regulatory activities with other departments • Review of product and manufacturing changes for compliance with applicable regulations • Review of protocols and reports to support regulatory submissions • Support international regulatory submissions (Korea, others) • Product support for minimally invasive structural heart technologies • Assist with IDE & PMA applications, amendments and supplements Qualifications: • BA or BS in a technical discipline with at least four years technical experience • One to three years regulatory experience • Experience with 510(k) applications and US device regulations • Experience with EU and Canadian medical device regulations and submissions |E-mail this position Submit Resume or C.V.2012-04-03 03:21:52United StatesSt. Jude MedicalMinnesota12900MNPlymouth, MN27603020http://jobs.sjm.com/xml/27603020/jobUSASt. PaulSr. Manager, Corporate Quality Audit Job Requisition #: Corp 12025 Date Posted: 04/02/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview The position is a replacement due to a recent promotion. The primary responsibility of this position is to develop and execute internal audit activities for St. Jude Medical’s manufacturing, design, and distribution centers globally. This position will also offer consultation services to St. Jude Medical in relation to Quality Management Systems, Continuous Improvement, and Best Practice Sharing across the enterprise. This position reports to the Director of Corporate Quality Systems and will work to ensure a uniform approach is taken to drive consistent and compliant activities across all product and sales divisions. Essential Functions: • Responsible for ensuring all elements of the corporate quality management system audit life-cycle are compliant with U.S. FDA QSR, and ISO requirements including: audit planning, scheduling, execution and reporting • Presentation of audit findings to local and division management and to executive management (as needed) of sites audited • Reports to corporate quality management potential systemic quality system issues across multiple divisions or facilities • Recommends and monitors corrective actions resulting from performed audits and provides best-practice sharing across divisions or facilities • Reviews, and in cooperation with the product divisions, makes recommendations on resolving major Quality Management System issues identified during product development life cycles, operations and post market activities • In coordination with divisional quality management, provides subject matter expertise to the divisional quality team members based on general operating procedures & technical requirements to ensure compliance with corporate policies, practices, and procedures • Assists divisional quality management in meeting the overall corporate quality objectives • Remains current on developments in field(s) of expertise, applicable regulatory requirements and restrictions, and a general knowledge of the company’s products, markets, policies, and objectives as well as industry trends (e.g. state of the art techniques in engineering and manufacturing, quality initiatives, Good Manufacturing Practices (GMP), as well as FDA, MDD and ISO requirements). Maintains expert knowledge of current and novel quality assurance practices through a review of key literature, trade journals, professional associations, and by attending conferences/seminars • Performs various related functions and responsibilities, as assigned by management Required Qualifications: • Bachelor’s Degree in Engineering, Science, a related field, or equivalent • 10+ years of progressively more responsible quality assurance and operations experience in a pharmaceutical, biological and or medical device environment including: • 3+ years experience working directly in a quality audit function role • Demonstrated working knowledge of US federal regulations relative to quality management systems in the medical device industry • Broad knowledge, preferably with hands on experience of medical device life-cycle from design, design transfer, production and process controls, to post market surveillance • Demonstrated ability to deliver QA information that adds value to management's decision making process • Demonstrated ability to understand and comply with applicable FDA and other international regulations and Company operating procedures, processes, policies, and tasks • Highly developed project management skills and experience sufficient to assume the responsibilities of this position, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines and develop written material for executive level review • Must be skilled at team building, influencing cross-functionality, communication and follow up • Must be able to work cooperatively and productively with others. Demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential • Advanced demonstrated personal computer skills including spreadsheet skills, word processing, data base management and other relevant applications • Ability to travel more than 50% at times to other divisions and facilities (domestic and international) Qualifications Desired: • An advanced credential in a relevant discipline/concentration (i.e., Master of Science (MS) degree in engineering/science) • Professional certification or designation • Academic or in-house courses in leadership, training, Continuous Improvement (CI), relational database and advanced statistical programs |E-mail this position Submit Resume or C.V.2012-04-03 03:21:51United StatesSt. Jude MedicalMinnesotaCorp 12025MNSt. Paul, MN27603019http://jobs.sjm.com/xml/27603019/jobUSASylmarClinical Research Associate III Job Requisition #: 12769 Date Posted: 03/27/2012 Category: Clinical Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working with limited direction, is responsible for assisting in the coordination of clinical data collection, researching and analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, and ensuring that site administration paper work is both complete and current. In addition, this position ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Coordinates the initiation of the clinical site, conducting clinical site audits, identifying and obtaining missing data and data corrections, maintaining accurate, detailed and complete records of audits and assisting in the reporting of study results. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year course of study. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager. Requirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of six plus years of experience as a Clinical Research Associate or equivalent experience which could include (but not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc.).Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Comprehensive personal computer skills including experience with word processing software and relevant clinical applications. The ability to concentrate on detail and work independently. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A familiarity with cardiac rhythm management technology, such as pacemakers, Heart Rhythm Society Heart Rhythm Society Certification in Electrophysiology (EP) and Implantable Cardioverter-Defibrillator (ICD)/Pacing or an equivalent certification of expertise, and with the clinical trial process is preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:30United StatesSt. Jude MedicalCalifornia12769CASylmar, CA27532238http://jobs.sjm.com/xml/27532238/jobUSAWestfordPlanner Job Requisition #: 12695 Date Posted: 03/30/2012 Category: Logistics Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division Essential Functions: • Global Sales & Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process • Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. • Zero backorder goal – when backorder exists full responsibility for backorder management, status, prioritization, communication • Production Plan attainment reporting and communication, including holding Operations accountable weekly to S&OP agreed upon production plans and notifying Accounting of variances to plan • Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals. • Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels • Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential • Proficient in ERP system functionality to perform job-including driving S&OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning Qualifications: • Bachelor Degree required • APICS or other Planning related certifications preferred. • Minimum 3 years experience in Planning function • Medical Device experience preferred. • Experience with SAP preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:29United StatesSt. Jude MedicalMassachusetts12695MAWestford, MA27532237http://jobs.sjm.com/xml/27532237/jobUSAWestfordEngineer - Quality Job Requisition #: 12635 Date Posted: 03/30/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-03-31 03:43:28United StatesSt. Jude MedicalMassachusetts12635MAWestford, MA27532236http://jobs.sjm.com/xml/27532236/jobUSAWestfordManager - Commodity Job Requisition #: 12693 Date Posted: 03/30/2012 Category: Purchasing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for setting and executing procurement strategies for goods and services required within the Division. In conjunction with supporting internal business areas and projects, identifies opportunities for cost reduction, develops and executes strategies to achieve them. Duties and Responsibilities: • Implement sourcing strategies to support objectives in the area of direct commodities (electronics, optics and plastics), providing the division competitive advantage in the areas of materials, supplies, and services • Locate, analyze and develop a consolidated supplier base to meet current and future commodity needs • Negotiate and manage contracts/agreements for assigned commodities • Help implement and train new ERP system (SAP) • Maintains and promotes sound relationships with suppliers and business community • Support projects to assure all procurement activities are performed as required. • Create and maintain mutually beneficial long-term partnerships with suppliers to foster feedback and continuous improvement. This includes driving continuous improvements with the supplier base. • Develop cross-functional teams to understand division-wide needs and evaluate suppliers • Manage suppliers, cost, quality, and delivery performance. Understand, track, and forecast the key cost drivers and market factors for assigned commodities Education and Experience: • Minimum of 8 years of progressive materials/procurement experience • Excellent verbal and written communication skills • Advanced knowledge of procurement principles • BA/BS in Business, Supply Chain, Finance or equivalent • Proven ability to lead, influence and motivate others |E-mail this position Submit Resume or C.V.2012-03-31 03:43:18United StatesSt. Jude MedicalMassachusetts12693MAWestford, MA27532230http://jobs.sjm.com/xml/27532230/jobUSASt. PaulSenior SAP Security Analyst Job Requisition #: Corp 12022 Date Posted: 03/26/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview St. Jude Medical is continuing to work through a multi-year SAP implementation while adding new phases. The SAP Security Team supports core SAP releases and new acquisition integration. The SAP Analyst is responsible for the development, implementation and maintenance of security objects within SAP systems. They will work with business areas and project teams to identify security requirements, developing security objects to meet those requirements, maintaining current and accurate documentation, and troubleshooting and resolving security issues when identified. They will also be responsible for understanding the risks and compliance issues facing global SAP implementations and helps define solutions to address such risks and issues. In this role there is a significant amount of variety to work with SAP modules, opportunity to bring process improvement ideas and opportunity for growth. Job Duties: • Gather requirements from internal clients and provide security and technical expertise to support the development of security objects to satisfy business requirements • Follow development processes and procedures to develop security objects that meet business requirements while adhering to the principle of least privilege. • Development, documentation, and execution of test protocols • Develop project plans, work breakdown structure and task dependencies, communication plans, etc. as needed • Provide effective written and verbal communications • Represent the security team in relevant change control processes • Prepare and maintain documentation as needed • Work with business areas and project teams to troubleshoot issues with security objects and identify and implement appropriate solutions • Interface with business, project, vendor and IT personnel to understand application changes that may impact SAP security and develop plans to assess impact and implement appropriate actions. • Support the security administration function to ensure SAP security object changes are appropriately incorporated into SAP access administration processes • Understand compliance requirements that may impact security and work with business areas and project teams to develop security solutions that address these requirements • Provide support to internal and external auditors and execute remediation plans when audit issues and concerns are raised • Serve as a security domain expert for the company, informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals • Provide updates and communication to customers, management and IT; escalate issues as appropriate • Other duties as assigned General Qualifications: • Bachelor’s Degree in Computer Science, MIS, or Mathematics, Engineering, Business or area of functional responsibility preferred, or equivalent 8 years of industry work experience • 5+ years of experience in maintaining and supporting security in SAP • Strong understanding and experience with Master and Derived roles, single and composite roles, role and position based security • Ability to translate complex business requirements into security requirements and develop, test and deploy the related security objects • Experience working in a broader enterprise/cross division business unit model • Ability to work in a highly matrix and geographically diverse business model • Ability to work effectively within a team and as an individual contributor in a fast paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner • Extremely strong verbal and written communications with ability to effectively communicate at multiple levels in the organization • Ability to recognize communications difficulties, diagnose the symptoms at the core, and work diplomatically to resolve them • Strong organizational, attention to detail and task follow-up skills • Adept at handling multiple assignments in a timely manner and meeting assigned deadlines |E-mail this position Submit Resume or C.V.2012-03-31 03:43:17United StatesSt. Jude MedicalMinnesotaCorp 12022MNSt. Paul, MN27532228http://jobs.sjm.com/xml/27532228/jobUSASylmarClinical Research Associate II Job Requisition #: 12800 Date Posted: 03/30/2012 Category: Clinical Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, applies clinical judgment to identify/resolve data discrepancies and implements corrections as needed. Is also accountable for analyzing and adjudicating adverse events from research sites, coordinating clinical data collection, analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, assists in the proper reporting of study results. In addition, ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Requirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of two plus years of related work experience as a Clinical Research Associate or equivalent (e.g., Research Coordinator) experience which should include (but is not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc. Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A general familiarity with cardiac rhythm management technology, such as pacemakers, and with the clinical trial process is preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:15United StatesSt. Jude MedicalCalifornia12800CASylmar, CA27532227http://jobs.sjm.com/xml/27532227/jobUSAWestfordIntern - Strategic Business Job Requisition #: 12852 Date Posted: 03/30/2012 Category: Internship Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview The Strategic Business Intern will be responsible for leading the strategic analysis of new healthcare technology alternatives in the field of cardiology. This analysis will include review of both clinical and cost effectiveness of new technologies in a developing market. This individual will be responsible for performing the competitive assessment of a range of novel approaches leading to recommendations to the senior executive team on strategy and investment options. This highly-visible role will contribute to the development and implementation of analysis and business strategies: • Early-stage collaboration with R&D and Clinical teams to develop a health economics perspective for a set of potential new products. • Budget impact models that calculate the potential economic and clinical impact of device usage for payers and hospitals • Literature review brochures and summaries The role involves frequent interaction with various groups within St. Jude Medical including, Marketing, Clinical Research, Research & Development and Regulatory. Essential Functions: • Perform competitive and health economic analysis, to recommend strategies to drive revenue growth for the Cardiovascular Division. • Lead the development and implementation of technology strategies that will support revenue growth for Cardiovascular Division products in key global markets. • Travel as necessary in key markets including customer visits, product training classes and tradeshows. Qualifications: • Current student pursuing Master's Degree or MBA in marketing, health aconomics, or finance • Must be enrolled in the 2012 Fall Semester • 3+ years experience in marketing, health economics, consulting or financial analyst role. • Medical device experience preferred. • Excellent interpersonal, written and verbal communication skills required; must be credible with high-level audiences. Assignment: Summer Internship Please Note: No housing, transportation or relocation allowance provided. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:04United StatesSt. Jude MedicalMassachusetts12852MAWestford, MA27532224http://jobs.sjm.com/xml/27532224/jobUSAWestfordTechnician - Process Development Job Requisition #: 12658 Date Posted: 03/30/2012 Category: Process Development Technician Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Work with Process Development engineers to develop manufacturing systems that include equipment and methods of using the equipment, measurement, analysis and control of the process variables. Essential Functions: •Develop, implement and test new processes and tooling. •Analyze and improve existing manufacturing processes. •Facilitate process development decision making using computer skills for design and analysis (SPC, Statistical Analysis) •Write and prepare technical reports, qualifications and validations •Manage business process compliance through process validation, equipment qualification, document control and equipment maintenance. •Maintain materials, tools and facilities necessary for production activities. •Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements. •Develop new manufacturing and design technologies by staying current in areas of focus. Qualifications: •2 year technical degree preferred •5+ years technician experience •General manufacturing processing knowledge •Solid processing equipment troubleshooting and qualification skills required •Solid data compilation and analysis skills required •Solid problem solving and organization skills required •Solid interpersonal and communication skills required |E-mail this position Submit Resume or C.V.2012-03-31 03:42:54United StatesSt. Jude MedicalMassachusetts12658MAWestford, MA27532217http://jobs.sjm.com/xml/27532217/jobUSASylmarEngineer, Principal Quality Assurance Job Requisition #: 12720 Date Posted: 03/30/2012 Category: Quality Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working without appreciable direction, designs and delivers design assurance engineering products, or processes. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. - Strong QA leader with demonstrated experience in addressing quality system and technical issues. - A background in electromechanical class III medical devices - Mechanical or electrical engineering degree holder - Demonstrated ability to work with people from diverse cultures and work with individuals/teams at off shore locations - Good knowledge of quality system regulations, ISO13485, and risk management ISO 14971 - Demonstrated ability to work with various levels of employees - A strong background in statistical techniques - Ability to critically analyze and improve upon existing procedures and develop new procedures as needed Requirements/Education: Bachelors Degree in Engineering (e.g., Electrical, Mechanical, Computer, etc.), or in a physical science, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience in a high technology manufacturing environment. Extensive knowledge and expertise at the forefront of the design assurance profession; applies, develops and promotes advanced concepts and practices; recognized authority in field. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems. |E-mail this position Submit Resume or C.V.2012-03-31 03:42:41United StatesSt. Jude MedicalCalifornia12720CASylmar, CA27532214http://jobs.sjm.com/xml/27532214/jobUSAWestfordEngineer Sr- Process Development Job Requisition #: 12591 Date Posted: 03/30/2012 Category: Process Development Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations. Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. • Establishes processes based on product specifications. • Evaluates process and design alternatives based on design for manufacturability” principles. • Understands principles of Cost of Goods Sold”. • Manages program compliance with Quality Control” requirements (i.e. Design Control, Process validation etc.). • Understands IP issues relative to processes being developed. • Maintains knowledge of new developments in manufacturing and design technologies. • Understand work environment issues (i.e. OSHA regulations, etc.) • May supervise or provide work direction to other engineers and technicians • May lead or serve as member on cross-functional project teams Qualifications: • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred • 10+ years manufacturing engineering experience • Experience designing and testing medical devices required • Experience developing manufacturing processes and technologies and designing for manufacturability required • Previous project management and people management experience required |E-mail this position Submit Resume or C.V.2012-03-31 03:42:39United StatesSt. Jude MedicalMassachusetts12591MAWestford, MA27532210http://jobs.sjm.com/xml/27532210/jobUSAWestfordTechnician - Quality Job Requisition #: 12516 Date Posted: 03/28/2012 Category: Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Briefly state the main purpose and scope of the position. This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. • As required perform in-process inspection including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements. • As necessary, assist in writing procedures and work instructions. • As necessary, document nonconformances and assist in the resolution of nonconformances • Initiate related documentation changes • Collect data, summarize, analyze, perform basic statistical analysis on, and document test results • As appropriate, assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • 2 year technical degree required • 3-5 years experience working with supporting Quality Engineering including NCMR. • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning • Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements preferred • Experience with hand tools, gages, pressure and force gage testing, and fixture design • Experience with fiber optic technology • Experience with ESD sensitize components/assembly • Training in blueprint reading and experience with sampling techniques • Good communication and computer skills, including data analysis and report writing skills • Prior medical device experience preferred • Solid computer skills in both Microsoft, Excel, Word and PowerPoint • Solid communication and interpersonal skills. • Solid data management experience. • ASQ CQT certification or equivalent preferred |E-mail this position Submit Resume or C.V.2012-03-28 20:56:15United StatesSt. Jude MedicalMassachusetts12516MAWestford, MA27463346http://jobs.sjm.com/xml/27463346/jobUSASunnyvaleEngineer I, Design Assurance Job Requisition #: 12632 Date Posted: 03/27/2012 Category: Quality Assurance Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Summary Working under close supervision on defined work assignments and/or usually following established procedures, supports the qualification testing of potential new products, accessories and components. Performs failure investigations on electrical circuits and subassemblies. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelor’s Degree in Engineering (e.g., Electrical, Mechanical, etc.), or in a physical science, a related field, or equivalent including relevant coursework and/or work experience in the design assurance profession. Requires demonstrated written and verbal communication, interpersonal, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must have the demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills and be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities. Desired Requirements: Prefer a degree in Electrical or Biomedical Engineering, experience in troubleshooting/failure analysis, specialized training, relevant coursework and/or a demonstrated understanding of design assurance engineering concepts, theory, and applications are desired. Experience in the implantable medical device industry. |E-mail this position Submit Resume or C.V.2012-03-27 20:24:08United StatesSt. Jude MedicalCalifornia12632CASunnyvale, CA27424323http://jobs.sjm.com/xml/27424323/jobUSASylmarTechnical Service Engineering Specialist Job Requisition #: 12789 Date Posted: 03/27/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. |E-mail this position Submit Resume or C.V.2012-03-27 20:23:38United StatesSt. Jude MedicalCalifornia12789CASylmar, CA27424313http://jobs.sjm.com/xml/27424313/jobUSADallasProgram Manager II Job Requisition #: NMD3158 Date Posted: 03/27/2012 Category: Project Management Program Management Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Program Manager II position manages small technical function or complex administrative unit or several smaller units. Working contacts are primarily internal with management and Associate network; may have some external contact in performing job. Provides input for business unit budget and tracks variances. Ensures that work performed on an assigned program meets schedule, cost, technical performance, customer satisfaction and people management requirements relative to technical performance in accordance with Corporate and Divisional Operating Procedures. Sets goals, ensures that they are met, and is responsible for continuous process improvement. Responsible for processes across organizational lines. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. May have specific process development and portfolio management activities. Ensures employee compliance with St. Jude and NMD policies. Job Responsibilities: • Implements programs and projects approved by management, assuring sound adherence to budgets and schedules. • Manages the deliverable items and oversees the program design history file. • Interacts with functional groups as necessary to define work breakdown structures/action items and to coordinate assigned projects/tasks as required to achieve program goals related to schedule, performance and cost. • Ensures that design review issues are resolved and reports are placed in the program file. Ensures that configuration management and change control process are followed. • Generates and distributes appropriate reports to keep management and team members informed of the status of the assigned programs. • Remains current on developments in management/leadership, neuromodulation field, regulatory requirements, as well as industry trends. • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. • Performs related functions and responsibilities, on occasion, as assigned. • Position requires experience in managing program/project teams and the delivery of products. Must be skilled at delegation, follow-up, and team building as well as a history of being able to multi-task and meet multiple project schedules on time. • Must be able to work cooperatively and productively with others. Comprehensive evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential; the ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and rules is also required. • Advanced personal computer skills including spreadsheet skills, word processing, data base management and other relevant project management applications. Experience & Training: • Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Software Engineering, a related field, or equivalent. • 3-5 plus years of progressively more responsible directly related experience leading to a broad, multi-disciplinary technical knowledge in the field. Medical device experience strongly preferred. • Has broad multi-disciplinary technical knowledge with expertise in multiple specialties. • Position requires experience in managing program/project teams and the delivery of products. Must be skilled at delegation, follow-up, and team building as well as a history of being able to multi-task and meet multiple project schedules on time. • Must be able to work cooperatively and productively with others. Comprehensive evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential; the ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and rules is also required. • Advanced personal computer skills including spreadsheet skills, word processing, data base management and other relevant project management applications. |E-mail this position Submit Resume or C.V.2012-03-27 20:23:33United StatesSt. Jude MedicalTexasNMD3158TXDallas, TX27424310http://jobs.sjm.com/xml/27424310/jobUSADallasFinancial Analyst Job Requisition #: NMD3159 Date Posted: 03/27/2012 Category: Finance Accounting Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working under general supervision, provides the primary focal point for Division financial analysis activities including the consolidation of all Division income statements, maintenance of monthly reporting, leading the annual plan process and quarterly forecasts and providing analytical insight into budget variances and operational performance. • Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. • Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager. • Assures that quality of services meets internal and external customer requirements. • Meet with various levels within organization and discuss challenges, areas of need, and identify possible improvements. • Remains current on developments in field(s) of expertise. Major, On-Going Responsibilities: • Coordinates all activity for the annual operating plan. • Coordinates all activity for the quarterly forecast. • Maintains and updates monthly reports. • Assists department managers in developing annual expense budgets. • Updates forecasts for other cost of goods sold expense items. • Provides detailed variance analysis for each function. • Develops and provides ad hoc analysis as required. Experience & Training: • A Bachelors Degree in Accounting or Finance required. • Typically a minimum of five plus years of progressively more financial analysis experience, including operating plans in a manufacturing environment • A demonstrated understanding of planning processes and how it impacts financial statements is required • Must have a strong understanding of basic accounting, financial reporting, and operational accounting issues • Experience in a manufacturing environment preferred • Must have experience working with significant ERP system ( SAP preferred or Oracle) and must have experience in either Essbase or Hyperion (Clearview and SAP BI/BW a plus) • Must be proficient with Microsoft Excel (Access a plus) • Must also be able to implement new design features as part of existing systems • Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees • Demonstrated ability to understand and comply with applicable FDA regulations (preferred) and Company operating procedures, processes, policies, and tasks • Demonstrated personal computer skills including spreadsheet, word processing database management, and specialized applications • Evaluation, originality, and/or ingenuity required Other Skills/Characteristics: • Customer Service Oriented • Excellent Communication Skills • Team player • Ability to multi-task • Proven process improvements • Goal Oriented |E-mail this position Submit Resume or C.V.2012-03-27 20:23:33United StatesSt. Jude MedicalTexasNMD3159TXDallas, TX27424309http://jobs.sjm.com/xml/27424309/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12713 Date Posted: 03/27/2012 Category: Technical Services Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. |E-mail this position Submit Resume or C.V.2012-03-27 20:23:10United StatesSt. Jude MedicalCalifornia12713CASunnyvale, CA27424287http://jobs.sjm.com/xml/27424287/jobUSACincinnatiTech Serv Specialist, EP Job Requisition #: USD 9542 Date Posted: 03/26/2012 Category: Health & Safety Location: Cincinnati - OH - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under moderate direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving both AF and CRM products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Requirements/Education: Bachelors degree in Bio-Medical Engineering or related field required. Requires SJM Brady, Tachy, CRT, Ensite, and EP certification within 12 months of hire date. Requires HRS certification. A minimum of two plus years increasingly responsible experience in the cardiac pacing and related industries. Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol. Demonstrated advanced knowledge of cardiac pacing systems is also necessary. Must apply engineering skills and abilities to interpret and solve complex pacing ECGs. Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines. Must have the ability to concentrate on detail and work independently. Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively. Must possess comprehensive personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc., to develop presentation materials. Placement into this position requires written approval by the Area Vice President (AVP). |E-mail this position Submit Resume or C.V.2012-03-26 20:58:17United StatesSt. Jude MedicalOhioUSD 9542OHCincinnati, OH27398981http://jobs.sjm.com/xml/27398981/jobUSASt. PaulManager, Demand Planning Job Requisition #: ID11737 Date Posted: 03/26/2012 Category: Finance Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN: Job Overview Works with European, Asia Pacific and Japan Geographies, as well as with the Atrial Fibrillation (AF) and Neuromodulation (NM) Divisions to improve supply chain service levels, decrease supply chain costs and improve asset management. Ensures timely and accurate net requirements forecasts from the ID geographies and works cross functionally to solve inventory management and supply chain issues. Strongly support or lead projects to improve service levels or costs throughout the supply chain. TYPICAL DUTIES AND RESPONSIBILITIES •Consolidate, prepare and analyze monthly net requirements forecasts •Supply chain liaison between International geographies and AFD/NMD •Manage process improvement – identifying leverage points for improvements to working capital levels/service levels/cost structures •Problem solving (supply chain, inventory, forecasting) •Support inventory management initiatives and events •Support special Supply Chain projects •Assist with acquisition integrations MINIMUM QUALIFICATIOS •Bachelor’s degree in Business Administration (Operations, Finance, Management, or Accounting) •7+ years experience in Operations (forecasting/planning, inventory mgmt) or Finance (financial analysis) •Strong MS Excel and quantitative analysis/ability while working with large data sets •SAP, SAP DP, Hyperion Enterprise, Business Objects •Ability to work with remote sites and travel as required •Exposure to accounting preferred but not required •Strong ability to prioritize and multi-task •Strong written and verbal communication skills PREFERRED QUALIFICATIONS •MBA •International experience |E-mail this position Submit Resume or C.V.2012-03-26 20:58:02United StatesSt. Jude MedicalMinnesotaID11737MNSt. Paul, MN27398975http://jobs.sjm.com/xml/27398975/jobUSASylmarServer Administrator, Senior Job Requisition #: 12787 Date Posted: 03/26/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Server Administrator, Sr Summary Working without appreciable direction, oversees, operates and coordinates large multi-tier systems, typically operational 24x7 basis with global users, and typically comprised of multiple technologies. Integrates multiple Information Technology (IT) technologies for delivery of system services. Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. Work requires the application of technical as well as business principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Implements St. Jude Medical Cardiac Rhythm Management Division (SJM/CRMD) and IT specific policies, practices and procedures to accomplish assignments and resolves a broad range of issues and problems. Performs special assignments and projects as directed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Assures that quality of services meets requirements. Remains current on developments in field(s) of expertise. Qualifications Requirements/Education: Requires a Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of technical experience in server, network or system operations including direct experience in a medium sized server environment or larger. Must possess demonstrated knowledge and application of advanced concepts and practices in two or more server operating systems, server hardware, file system concepts and management. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, network, storage/SAN, system backups, security, telephony, Internet-based infrastructure, public facing systems). Demonstrated knowledge of and experience with integration of storage, data communications/ networking, and security implementation. Good oral and written interpersonal, communication skills to deliver customer-focused service. Excellent analytical, presentation, and organizational skills and the ability to meet multiple deadlines and work independently. Must be able to manage an assignment from start to completion; must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Ability to use discretion and handle sensitive/confidential information. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. Must also have demonstrated effectiveness in the expeditious execution of IT transactions and the ability to work with clients as a strategic business partner. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MCSE) and/or Cisco Networking certifications. Ability to program in an administrative language (e.g., Perl, shell scripting). |E-mail this position Submit Resume or C.V.2012-03-26 20:58:01United StatesSt. Jude MedicalCalifornia12787CASylmar, CA27398974http://jobs.sjm.com/xml/27398974/jobUSAIrvinePrincipal Product Development Engineer Job Requisition #: AF13821 Date Posted: 03/26/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, leading hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Leads the design and process development of new products • Represents Product Development on cross functional product development teams • Applies engineering/ design/ process knowledge to the development of new products • Manages engineering and technician support assigned to the project • Develops schedules and timelines for project work and tracks to and updates • Authors designs control documentation including specifications, requirements, reports, and protocols • Provides engineering, design and technical support of products introduced currently in release. Required Qualifications: • BS in Mechanical or Biomedical Engineering • 10 + years experience in catheter based product design/ R&D in Medical Device industry • 3+ years project leadership or management experience • Demonstrated knowledge of successful process development- process identification and process characterization • Track record of successful product transfer from Product Development to Manufacturing • Demonstrated ability to work with manufacturing to improve products and processes to increase yield(s) • Experience with medical design from initial concept generation to manufacturing • Strong analytical reasoning • Experience working within medical device regulatory systems (FDA Design Controls, ISO9001, GMP) • Polished communicator • Excellent documentation writing skills; clear and concise using objective evidence and language • Excellent reputation for building relationships • Organized, on-time, and detailed skills • Energized attitude Preferred Qualifications: • MathCAD experience • Knowledge of electrophysiology • Working knowledge of statistics • Experience w/Cardiac anatomy • Tissue ablation • Catheter design To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-26 20:58:00United StatesSt. Jude MedicalCaliforniaAF13821CAIrvine, CA27398973http://jobs.sjm.com/xml/27398973/jobUSASt. PaulMarketing Manager, CRM Job Requisition #: ID11736 Date Posted: 03/22/2012 Category: Marketing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN: Job Overview The Marketing Manager is responsible for managing a team of Product Managers to build the commercial roadmap for assigned CRM products by working across all International Division geographies. The Marketing Manager will act as a key interface between our International Customers, our geographic sales teams and the Product Division. Be responsible for the development of specific marketing plans and activities for specific products to establish, enhance or distinguish product placement within the competitive arena. Develop business plans and product positioning in the marketplace. Oversee market research, monitor competitive activity, and identify customer needs. Establish pricing strategies. Monitor product franchise results and develop and implement marketing and business strategies to achieve sales plan. TYPICAL DUTIES AND RESPONSIBILITES •Manage product managers and work with geographies and product division to build the commercial roadmap for assigned products. This includes: oDefining target markets which are appropriate to achieve revenue expectations oDetermining pricing oCreating customer product information collateral oCreating customer training collateral oCreating sales training material oConducting sales product training •Develop appropriate strategies and plans in order to monitor and respond to changes in the market place, competitors, and performance versus objectives by major geography. oTrack success of assigned products including metrics, strengths, gaps, strategies, etc. oManage key metrics to identify product penetration in global markets oProvide analyses that highlight sales opportunities, trends and issues •Partner with global sales management to secure necessary sales representative attention •Plan and prepare product launches in cooperation with the Product Division/International Marketing and facilitate implementation throughout the geographies oEnsure products are properly positioned and that marketing plan will support sales objectives •Maintain global programs for products which have already been released including customer loyalty programs and appropriate campaigns •Develop and maintain relationships with key opinion leaders •Manage performance of direct reports by coaching staff on regular basis oConducting performance evaluations in a timely manner oRewarding for excellent performance, addressing poor performance and managing employee development plans oManage the completion of quality and compliance requirements for team •Contribute toward the development of an annual departmental budget by forecasting future needs, utilizing previous year’s budget, current objectives and budget guidelines. MINIMUM QUALIFICATIONS •BA/BSN/BAN/BS •4+ years work experience in the medical device industry •4+ years in marketing and/or equivalent applicable experience •Skilled in use of spreadsheet, database and presentation software •Strong analytical, strategic and problem-solving skills required •Work effectively in a complex, multi-tasking environment •Strong individual self starter who has ability to develop and execute on plans •Strong influence management skills—effectively influences a wide variety geographies/cultures and functions including regulatory, sales, marketing, research and manufacturing •Excellent communication skills—has frequent contact with key opinion leaders and broad customer contact as well as interfaces with senior-level management from cross functional groups and geographies to facilitate strategic decisions. •Strong team player—ability to work as a key member of the International Division marketing team. •Strong leadership skills—ability to function as the marketing lead” on high profile projects around the world. •Project management skills—ability to manage complex projects and programs. Ability to pull the appropriate functional and geographic functions together to support initiatives. PREFERRED QUALIFICATIONS •MBA with marketing emphasis preferred •2 + years international marketing experience within medical device industry •2 + years marketing management experience •2 + years medical device sales experience •Knowledge/experience with customer base and with international health care markets •Understanding of medical products clinical and regulatory process and environments TRAVEL REQUIREMENTS •20-25% to international locations including Europe, Asia Pacific and Japan PHYSICAL DEMANDS/WORK ENVIRONMENT Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position requires significant independent travel to all international locations of St. Jude business interests outside of the US. |E-mail this position Submit Resume or C.V.2012-03-22 20:58:55United StatesSt. Jude MedicalMinnesotaID11736MNSt. Paul, MN27326339http://jobs.sjm.com/xml/27326339/jobUSAPlymouthDemand Planner Job Requisition #: 12663 Date Posted: 03/21/2012 Category: Purchasing Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary: Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division Essential Functions: • Global Sales & Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process • Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. • Zero back order goal - when back order exists full responsibility for back order management, status, prioritization, communication • Production Plan attainment reporting and communication, including holding Operations accountable weekly to S&OP agreed upon production plans and notifying Accounting of variances to plan • Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals. • Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels • Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential • Proficient in ERP system functionality to perform job-including driving S&OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning Qualifications: • Bachelor Degree required • APICS or other Planning related certifications preferred. • Minimum 3 years experience in Planning function • Medical Device experience preferred. • Experience with SAP preferred. |E-mail this position Submit Resume or C.V.2012-03-22 01:48:21United StatesSt. Jude MedicalMinnesota12663MNPlymouth, MN27314755http://jobs.sjm.com/xml/27314755/jobUSAPlymouthDemand Planner Job Requisition #: 12664 Date Posted: 03/21/2012 Category: Operations Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview Position Summary: Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division Essential Functions: • Global Sales & Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process • Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. Seamless coordination with Supply Chain Supply Side Planning to meet overall planning objectives • Manage Zero back order goal – when back order exists full responsibility for back order management, status, prioritization, communication • Sales and net requirements forecasts review and attainment, holding key geographies accountable to their forecasts thru measurement and communication • Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals. • Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels • Facilitate and coordinate key CVD quarterly/annual planning processes like Strat Plan, OP Plan, and quarterly production volume and inventory forecasting • Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential. • Proficient in ERP system functionality to perform job-including driving S&OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning • Proficient in Excel, PowerPoint and other Microsoft software Qualifications: • Bachelor Degree required. • APICS or other Planning related certifications preferred. • Minimum 3 years experience in Planning function. • Medical Device experience preferred. • Experience with SAP preferred. |E-mail this position Submit Resume or C.V.2012-03-22 01:48:21United StatesSt. Jude MedicalMinnesota12664MNPlymouth, MN27314756http://jobs.sjm.com/xml/27314756/jobUSASylmarEngineer II, Clinical-Systems Job Requisition #: 12553 Date Posted: 03/20/2012 Category: Systems Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Engineer II, Clinical-Systems Summary Working under general supervision, supports product development efforts by performing clinical-systems engineering tasks such as investigating, defining, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Responsible for gaining a firm understanding of clinical applications, customer needs to be addressed, behaviors, and architected solution of the assigned portion of the system. Performs additional analysis and/or interviews to determine requirements and constraints on the assigned portion of the system and to resolve cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Demonstrates aspects of technical or organizational leadership within the current projects. Has ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating clinical-systems engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelors Degree in Biomedical Engineering, a related field, or equivalent including relevant coursework and/or work experience in product development (especially definition and validation), cardiology and electrocardiogram interpretation. Typically a minimum of two plus years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is also required. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Documented record of delivering clinical-systems engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Desired Requirements: An advanced credential in a relevant discipline/concentration; a Biomedical Engineering degree is preferred. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Six-Sigma, and various technical applications as noted above. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2012-03-20 20:33:08United StatesSt. Jude MedicalCalifornia12553CASylmar, CA27272207http://jobs.sjm.com/xml/27272207/jobUSAWestfordTechnician - Maintenance Job Requisition #: 12602 Date Posted: 03/19/2012 Category: Manufacturing Technician Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Provide manufacturing support to production operators, engineering, and quality departments in a team environment. Essential Functions: •Identify, analyze, and implement manufacturing improvements (e.g., processes, yields, and productivity) •Test/troubleshoot manufacturing processes and equipment •Modify existing and develop new tooling and fixtures •Summarize, analyze, and provide recommendations from test results •Assist in writing technical reports by capturing experiemental results and demonstrating technical writing skills •Support new product introductions •Support process validation activities for continuing production and for new product •introductions •Set-up production processes using established procedures and processes Qualifications: •2 year technical degree preferred •5+ years experience, preferably in medical device industry •Demonstrated experience in molding, tooling, troubleshooting equipment, and performing machine and process set-ups •Experience in GMP, ISO, and FDA controlled environments preferred •Proficient computer, data analysis and report writing skills |E-mail this position Submit Resume or C.V.2012-03-19 18:32:35United StatesSt. Jude MedicalMassachusetts12602MAWestford, MA27237705http://jobs.sjm.com/xml/27237705/jobUSAWestfordEngineer - Packaging Job Requisition #: 12612 Date Posted: 03/19/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Support packaging and labeling processes for established product lines. Develop packaging and labeling for new products. Essential Functions: •Select, procure, install, and validate packaging and labeling equipment •Conduct Process FMEAs •Identify and implement packaging/labeling process improvement projects •Design, develop and test a wide variety of packaging used for the protection, display, and handling of products •Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering •Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques •Responsibilities may include documentation management and an understanding of Good Manufacturing Practices (GMPs) •Creation and management of change requests within the document control system (currently Windchill) •May supervise or provide work direction to other engineers and technicians •May lead or serve as member of cross-functional project teams Qualifications: •Packaging Engineering or Mechanical Engineering degree •5+ years experience in packaging or material handling •Medical device experience preferred •Understanding of FDA, GMP, and ISO guidelines •Experience with equipment process validation principles as well as engineering documentation practices and statistical process control •Requires ability to be innovative, resourceful, and work with minimal direction •Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams |E-mail this position Submit Resume or C.V.2012-03-19 18:32:33United StatesSt. Jude MedicalMassachusetts12612MAWestford, MA27237703http://jobs.sjm.com/xml/27237703/jobUSAWestfordEngineer - Manufacturing Job Requisition #: 12599 Date Posted: 03/19/2012 Category: Manufacturing Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Essential Functions: Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians. Additional responsibilities include: •Provide technical mentorship to engineers and technicians •Conduct Process FMEAs and Process Validations •Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts •Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Qualifications: •Mechanical, Chemical or any engineering or technical degree required, or equivalent experience •5+ years manufacturing engineering experience •Medical device experience required •International manufacturing experience preferred •Strong analytical, problem solving and project management skills •Demonstrated leadership capability in team settings •Six Sigma certification preferred •25% travel required |E-mail this position Submit Resume or C.V.2012-03-19 18:32:21United StatesSt. Jude MedicalMassachusetts12599MAWestford, MA27237694http://jobs.sjm.com/xml/27237694/jobUSASylmarEngineer I, Design Assurance (software) Job Requisition #: 12700 Date Posted: 03/16/2012 Category: Quality Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under close supervision on defined work assignments and/or usually following established procedures, supports the qualification testing of potential new products, accessories and components. Possess a solid understanding of software development, verification and validation activities, processes, approaches, and methodologies. •Work with Software Engineers on the software development process, including document review, technical review meetings, change control meetings and auditing. •Monitor software configuration management, defect tracking and requirements using software tools such as ClearCase, ClearQuest and DOORs. •Implement process improvements that add value to software development projects, contribute to finding bugs earlier, and prevent failures from reaching the field. •Conduct review meetings for issues found during audits and ensure that all issues are resolved before regulatory submission. •Develop, follow and maintain internal SOPs, department work instructions, project audit plans and audit summary reports. •Schedule and perform software validations as needed for quality system software used throughout the company. •Support other departments in the validation of software for quality systems, including in-house and commercially developed software. •Must possess excellent oral and written communication skills with the ability to effectively convey schedules, issues, and results in documents, emails, and meetings. •Must be able to complete projects on schedule with a high quality results. •Must be a detail oriented person who can diplomatically catch mistakes and get corrections made. •Must have high energy and enthusiasm with a history of successful team participation. looking for a mature and responsible new grad (or soon-to-be grad) with a degree in Software Engineering, Computer Engineering or Computer Science and who has elective coursework in some of the following areas: • UNIX • Computer Security • Software Testing • Software Process • Software Quality • Web Programming and Data Management |E-mail this position Submit Resume or C.V.2012-03-16 19:25:34United StatesSt. Jude MedicalCalifornia12700CASylmar, CA27208003http://jobs.sjm.com/xml/27208003/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12621 Date Posted: 03/15/2012 Category: Quality Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. Candidate that can work in a fast-paced environment, with attention to detail, meet deadlines, and has excellent organizational skills. Knowledge in FDA CDRH regulations a plus. |E-mail this position Submit Resume or C.V.2012-03-15 21:38:22United StatesSt. Jude MedicalCalifornia12621CASunnyvale, CA27178514http://jobs.sjm.com/xml/27178514/jobUSAMinnetonkaSenior Quality Manager Job Requisition #: 12689 Date Posted: 03/14/2012 Category: Quality Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview The Senior Quality Manager – Documentation is responsible for the development, establishment and maintenance of Quality Documentation systems, programs, policies, processes, procedures and controls that ensure the performance and quality of products conform to established standards and agency regulations. Responsibilities: • Provide overall Documentation Systems leadership for the deployment, coordination and oversight of the goals and objectives for Divisional and SJM Enterprise Documentation Systems activities to Divisional Documentation Managers and teams globally. • Provide expert level guidance and direction of the Documentation Systems Body of Knowledge • Aggressively identify opportunities to proactively assure compliance of Documentation Systems to all applicable internal, domestic and international quality regulations, to include, but not limited to: o U.S. FD&C and 21CFR11, 21CFR820 o EN ISO 13485 o CAN MDR SOR/98-282 and CAN/CSA: ISO 13485 • Aggressively identify and manage Documentation Systems activities related to adding value to the organization through systems and controls improvement, risk and cost reduction, and fiscal budgetary responsibility. • Provide influential leadership with International sites to drive proactive Documentation Systems innovation and improvement. • Identify Documentation Systems Initiatives and lead cross-functional teams to complete them. • Provide diligent and fact-based communication to Executive Management team, peers, and team. • Assess resource needs to assure that the accurate level of support is provided when needed with the competencies needed. Requirements: • Bachelor’s Degree • 8+ years in Documentation Control desired • 5+ years leadership and management of demonstrated compliance excellence, value improvement, risk reduction, and cost management • Medical Device or other Regulated Manufacturing background • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies • Ability to travel internationally to support international manufacturing sites • Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired • Strong project management, team skills, and influential management highly desired |E-mail this position Submit Resume or C.V.2012-03-14 19:07:39United StatesSt. Jude MedicalMinnesota12689MNMinnetonka, MN27138034http://jobs.sjm.com/xml/27138034/jobUSAPlymouthSenior Data Warehouse Architect Job Requisition #: 12605 Date Posted: 03/14/2012 Category: Information Technology Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Senior Data Warehouse Architect will perform necessary duties to design/model, maintain, and optimize multiple data marts and data warehouses within our database environments. The architect will also share responsibilities for Extraction, Transformation & Loading for the data warehouse. Responsibilities: • Analysis, design, development & support of the CVD data warehouse environment • Team member to support Informatica & Business Objects • Assist in ETL development efforts, making sure that the business rules are implemented correctly • Diagnose and propose solutions for database and report performance issues • Other areas of responsibility are Data Strategy, ETL Architecture, ETL development, reference data management and data quality improvement Requirements: • Bachelor’s degree • 8+ years of IT experience • 5+ years as a Data Architect • 3-5 years experience with SQL Server • Full life cycle experience implementing BI architecture and data warehousing solutions • Strong conceptual, logical and physical data modeling experience • Performed and led data migration efforts • Thorough understanding of BI / DW concepts • Hands on experience in writing, executing and debugging SQL • Experienced with ER Diagrams and data modeling tools such as ErWin • Experience with identifying reporting and information requirements • Excellent communication skills • Strong analytical, problem solving, and research skills Preferred Qualifications: • Medical Device industry exposure or experience • Working knowledge of Informatica • Working knowledge of Oracle • Bachelors degree in CS, Mathematics, MIS, Engineering, etc. |E-mail this position Submit Resume or C.V.2012-03-14 19:07:30United StatesSt. Jude MedicalMinnesota12605MNPlymouth, MN27138028http://jobs.sjm.com/xml/27138028/jobUSAMinnetonkaSr Manufacturing Technician Job Requisition #: AF13815 Date Posted: 03/13/2012 Category: Technician Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Senior Manufacturing Engineering Technician to join our Advanced Process Development (APD) team based in Minnetonka. This role will provide engineering support to a variety of process development projects led by Process Engineers in APD group., This position is a 1st shift, Monday-Friday opportunity. Impact this role will have within the AF division: • Identify, analyze, and implement manufacturing improvements (e.g., processes, yields, and productivity). • Participate in cross-functional projects related to new process development led by Process Engineers in APD group. • Develop and execute engineering builds to support process characterization and qualification studies. • Summarize, analyze, and provide recommendations from test results. • Support process validation activities for process development and new product introductions. • Modify existing and develop new tooling and fixtures for new process development. • Assist in writing technical reports by capturing experimental results and demonstrating technical writing skills. Required Qualifications: • Two year technical degree. • 5+ years of medical device industry experience. • Flexibility to work over-time as needed. • Demonstrated experience in catheter assembly, equipment qualifications, troubleshooting equipment, and performing initial machine/ process set-ups. • Experience in GMP, ISO, and FDA controlled environments preferred. • Proficient computer, data analysis and report writing skills. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Energetic, organized, on-time, and detailed project management skills. Preferred Qualifications: • SAP • Windchill (PDM) • Experience sourcing new equipment and vendors To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.2012-03-13 23:44:31United StatesSt. Jude MedicalMinnesotaAF13815MNMinnetonka, MN27117047http://jobs.sjm.com/xml/27117047/jobUSAIrvineSenior Design Quality Engineer Job Requisition #: AF13715 Date Posted: 03/13/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Design Quality Assurance Engineer to join our organization. This Senior Engineer partners with employees on cross functional teams focused on new product development. This DQE leads and ensures new product designs are in compliance in the following critical areas- marketing/user requirements, technical/engineering specifications, technical drawings, design verification and design validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, and manufacturing procedures. Impact this role will have within the AF division: • Provide guidance to support completion of new product development quality deliverables: risk analyses and reports including FMEAs and Fault Tree Analyses; quality, shelf life, packaging, biocompatibility, and sterility assessments and plans; others. • Review and provide guidance on creation of new product development process deliverables, ensuring deliverables meet internal requirements: marketing/user requirements, technical/engineering specifications, technical drawings, design verification and validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, manufacturing procedures, etc.. Work with process owners to develop procedures and work instructions for design control and new product development. • Ensure new product design compliance to internal Standard Operating Procedures (SOPs) and International Standards Organization 13485 and 21Code of Federal Regulations Part 820 Quality System Regulations. Ensure internal SOP compliance to external regulations. • Support and lead failure investigations including root cause analysis, correction, corrective/preventive actions, Design History File updates. Subject Matter Expert for failure investigation techniques and documentation. • Communicate any quality-related issues to Quality Management, propose and lead implementation of appropriate corrective actions. Prepare corrective action implementation project plan and schedule. • Subject Matter Expert for evaluation of effectiveness and safety of new product designs using understanding of the physiology and electrical systems of the human heart (including phenomena associated with atrial fibrillation), atrial fibrillation-related Electrophysiology (EP) lab procedures and equipment use cases, and knowledge of the design, function, and typical failure modes of devices manufactured by SJM-AFD. Required Qualifications: • B.S. Engineering degree. • Extensive product and process validation experience. • Strong written and oral communication skills. • Successful track record of being organized, ability to prioritize, and working both independently and in teams. • Experience with new product development process through project completion under 21CFR Part 820 or Medical Device Directive regulations. • Understand and able to provide guidance regarding statistical decision-making (ANOVA, hypothesis testing, goodness-of-fit, etc.), data analysis (data types, accuracy vs. precision, mean/range/standard deviation), statistically sound sampling plans and acceptance criteria, measurement system analysis (Gauge R&R, capability), risk/hazard analysis techniques (FMEA/FMECA, FTA). • 7+ years of QA experience within the medical device industry. • Experience with MS Word, MS Excel, MS Visio, Minitab. • Great reputation for leading and driving change on multiple projects. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. • Ability to influence others without authority. Preferred Qualifications: • Preferred degrees are related to medical devices, such as Biomedical or Electrical Engineering degree. • CQE, CQA certification. To learn more, visit our web site at www.sjm.com St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-13 23:44:27United StatesSt. Jude MedicalCaliforniaAF13715CAIrvine, CA27117043http://jobs.sjm.com/xml/27117043/jobUSAWestfordService Manager Job Requisition #: 12661 Date Posted: 03/12/2012 Category: Operations Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview The Manager of Service is responsible for a wide range of activities required for the introduction, installation and maintenance of OCT systems. Essential Functions: • Lead the refurbishment and repair of returned product for OCT and FFR, including tools, calibration and testing equipment and processes. • Identify failure trends and associated root cause and statistical analysis and communicating this to the rest of the organization. • Creating demand plan for services, work with manufacturing and quality to ensure timely product flow. • Establishing and staffing the service organization, training and departmental budget management. • Interfaces with USD and ID field service functions and Engineering regarding repair issues • Champions and enables methodologies of continuous process improvement including defining and reporting departmental performance metrics. • Assists Regulatory throughout the process of complaint handling related to CVD capital equipment and peripherals. • Represents services in a cross-functional capacity while interfacing quality assurance and sustaining engineering groups. • Oversees content development and manages distribution of all technical documents including Work Instructions, Technical Bulletins, IFU's, Software Release Notes, Service Manuals, etc. • Works in conjunction with worldwide Capital Services (US, Europe, and Japan) in the planning and execution of system upgrades, software releases, field corrective actions, and other planned service events. • Collaborates with Engineering and Marketing on special projects related to new product releases and next generation products. • Works in conjunction with R&D in design for serviceability projects, including systems integration, networking, and remote connectivity. • Represents and coordinates advanced technical and applications support at the product divisional level by enabling collaboration with engineering. • Manages in-house product training and education programs related to capital equipment servicing for new hire and continuing education. • Monitors and maintains refurbished materials stock including asset management of the demo/eval systems fleet. • Coordinates and manages planned maintenance and other serviceability of all SJM owned systems that are installed in-house. • Clearly communicate expectations and goals to employees Qualifications: • B.S. in engineering or equivalent • 10 years of hands-on field service experience • 5+ years experience with software-based, complex electro-mechanical medical devices • 3 to 5 years product service management experience • Excellent organizational, communications and troubleshooting skills • Experience managing direct reports and contractors in a field service environment • Familiarity with QSR and ISO13485 is desirable |E-mail this position Submit Resume or C.V.2012-03-12 19:08:46United StatesSt. Jude MedicalMassachusetts12661MAWestford, MA27084724http://jobs.sjm.com/xml/27084724/jobUSANoneProduction Supervisor Job Requisition #: 12631 Date Posted: 03/09/2012 Category: Manufacturing Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Provided leadership to the production teams to deliver the business results and expectations on a day to day basis. This position requires elevated training in human resources/people skills, quality systems, and manufacturing processes. The position is responsible for ensuring that standard production processes are maintained and that production volumes and quality are met. Requirements/Education: Bachelor degree in engineering science (Industrial or Mechanical) or Business Administration (Industrial Management). Three to five years of prior supervisory experience in a medical device, pharmaceutical, or electronic industry preferred. Capacity to define problems collects data, establish facts and draw valid conclusions. Must have excellent interpersonal and team work skills. Must be bilingual (English and Spanish), computer literary (MSFT applications and MFG software) preferred Knowledge of ISO and quality systems. Knowledge of SAP a plus. Must have good people skills with the ability to energize and motivate a staff. |E-mail this position Submit Resume or C.V.2012-03-09 23:22:12United StatesSt. Jude MedicalNone12631NoneVirtual, USA27053176http://jobs.sjm.com/xml/27053176/jobUSASt. PaulQuality Specialist II Job Requisition #: 12582 Date Posted: 02/28/2012 Category: Quality Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview The Quality Specialist II conducts internal quality audits to assess compliance to the requirements of FDA, ISO, MDD, CDR, Japan, and other regulatory bodies applicable to the Cardiovascular Quality System. This position will also participate in and support CVD during external regulatory audits. Responsibilities: • Conduct internal CVD compliance audits at any CVD facility • Set the audit schedule, maintain the schedule, and/or update it as necessary • Write thorough reports of the audits conducted and fully inform participants, managers of the audited area, and quality management of the audit results • Prepare for external audits • Be a support and/or participant during external audits • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Requirements: • Bachelor’s degree required • 3-5 years experience in the medical device industry • 1-3 years auditing experience per ISO and/or FDA standards • Lead Auditor Certification for ISO 13485 or 9001:2000 preferred. • Excellent writing skills are required Preferred qualifications: • Knowledge of MDD, Japan, Australian, and other geographic regulations |E-mail this position Submit Resume or C.V.2012-03-09 23:21:05United StatesSt. Jude MedicalMinnesota12582MNSt. Paul, MN27053140http://jobs.sjm.com/xml/27053140/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: CRT13046 Date Posted: 03/08/2012 Category: Assembly Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Assembler of high-tech cardiovascular medical devices. Duties in this role will include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 2nd shift, Monday-Thursday opportunity. Impact this role will have within the CRM division: • Proficient assembly and packaging of medical devices by following company procedures and all processes within the primary work area, while meeting or exceeding quality and production standards. • Use of magnification and other equipment required to perform assigned job(s). • Understands and accurately completes necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, such as including training support as defined by area Group Leader. Required Qualifications: • High school diploma or equivalent. • 6+ months of high tech assembly experience. • Must be able and willing to work over-time. • Must have demonstrated ability to read, understand written procedures and follow directions. • Must have a high level of attention to detail. • Organized, on-time and detailed. • Energized attitude. Preferred Qualifications: • 6+ months of medical device industry experience. To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-08 18:20:26United StatesSt. Jude MedicalMinnesotaCRT13046MNMinnetonka, MN27010058http://jobs.sjm.com/xml/27010058/jobUSASt. PaulSupervisor - R&D Technician Job Requisition #: 12636 Date Posted: 03/08/2012 Category: Engineering Technician Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: This person will supervise the R&D technician pool for the Engineering Test Lab (ETL) located at the Woodridge facility in St. Paul, MN. Essential Functions: Organize and provide leadership to St. Jude Medical-Cardiovascular Division's lab where new prosthetic heart valves are evaluated for performance. • Supervise technicians including; communicating regularly with engineers and R & D management regarding setting priorities, support needs, status and quality of work done. • Create development plans with reports to continue to improve skill and team’s capabilities. • Develop and execute plans to enable the lab to meet the growing and changing needs of the business. • Provide work direction to technicians to support project work. • Provide assistance to technicians and train on use of equipment, materials, and technical practices. • Troubleshoot and suggest creative solutions to process, test method and design issues. • Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Quality function. • Use internal and qualified external vendors to assist engineering teams to obtain supplies and services. • Test prototypes per engineering instructions and document test results. • Conduct yearly performance reviews by obtaining feedback from engineers and R&D management in addition to own assessment of technician’s performance. Other Duties: • Insure lab supplies and equipment are adequate and in working order, support improvements to Lab. • Ensure technician’s goals are in line with upper management’s objective. • Interview potential employees and make recommendations/hire for employment. • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • Two year technical degree or equivalent experience • Bachelor’s degree in science or technology preferred • 7-10 years technical experience, with at least 2 years supervisory experience • Experience developing and testing medical devices. • Experience with a variety of manufacturing processes required. • Excellent written and verbal communication skills. |E-mail this position Submit Resume or C.V.2012-03-08 18:20:12United StatesSt. Jude MedicalMinnesota12636MNSt. Paul, MN27010050http://jobs.sjm.com/xml/27010050/jobUSASt. PaulDirector, Project Management Office (PMO) Job Requisition #: Corp 12016 Date Posted: 03/07/2012 Category: Information Technology Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview This position is open due to an internal promotion. The PMO Director has overall accountability and responsibility to plan and manage the resources and processes used to identify, develop, prioritize and implement strategic and tactical enterprise systems projects. This is a great opportunity to work with a mature group of direct reports and continue to evolve the PMO by planning a 3+ year road map. This position also has responsibility for the development of processes and methods that govern the execution of those projects (e.g. methodology development). The position requires outstanding knowledge of enterprise business solutions, an ability to facilitate cross-organizational collaboration at a senior leadership level, and an ability to manage complex work and team environments to the successful delivery of enterprise solutions. Preference will be given to local candidates. Essential Functions: • Build a working demand management process for key enterprise applications (e.g. SAP) to allow realization of business requirements for ongoing solution improvements and enhancements. Includes demand intake, evaluation, prioritization, and delivery as well as management of funding, budgeting, and chargeback models. • Manage a portfolio of enhancement work for the SAP environment including multiple releases of new functionality. • Manage other enterprise programs and projects as required • Develop portfolio and program plans providing project architecture for complex, multi-phase initiatives. Develop and execute project plans utilizing a project management methodology and project planning tools. • Monitor portfolio, program, and project status and report to senior management or steering committee. • Provide architectural input where needed to ensure portfolios and projects are aligned to overall business strategy and IT standards. • Develop and maintain an outstanding customer service relationship with business, division IT management, and team members. Qualifications: • 15+ years IT experience using a standard IT methodology, with 10+ years in a program, project, and line management roles. • Bachelor's degree in Business, Computer Science, Engineering or related field. • Proven success in implementing, improving, and supporting enterprise-wide projects (e.g. ERP). • Experience managing programs and/or project portfolios. Specific experience managing SAP enhancement processes from business interaction through implementation is a strong plus. • Functional expertise in one or many key functional areas (especially Supply Chain and Finance). • Self motivated with and ability to build new processes and methods leveraging past experience. Excellent planning, interpersonal, organizational, documentation, verbal and written communication skills • Experience with MS Project, Excel, Word and Visio. * Ability to travel - up to 15% Preferred Qualifications: * International experience * Experience with Project Portfolio Management (PPM) applications * Advanced degree (e.g. MBA) * Experience in Medical Device or Life Science industries * Project Management certification |E-mail this position Submit Resume or C.V.2012-03-07 22:20:52United StatesSt. Jude MedicalMinnesotaCorp 12016MNSt. Paul, MN26992077http://jobs.sjm.com/xml/26992077/jobUSASt. PaulApplied Research Intern Job Requisition #: AF13805 Date Posted: 03/07/2012 Category: Internship Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Intern to help develop biologically representative active bench model to be used for catheter and system testing. The successful candidate would be capable of mechanical drawing preferably in Solid Works or ProE. Strong mechanical skills are needed, but also a solid understanding of electronics and biological studies. Strong communication skills are required for this position since there will be substantial interaction with many groups within the organization. The successful candidate will document the completed device, test and modify as required and verify that it meets the requirements. Individuals in this position will work closely with fellow research scientists and technicians helping out with various tasks as well as complete assigned projects independently. Impact this role will have within the AF division: • Mechanical design of biologically representative bench model • Work with internal or external vendor to fabricate bench model • Assemble, test and modify device as needed. • Test and verify that the model meets the agreed upon requirements • Provide end of summer presentation for SJM senior management Required Qualifications: • Candidates should be pursuing a bachelor’s degree in mathematics, physical science, or other engineering disciplines (Biomedical, Chemical, Computer, Electrical, or Mechanical Engineering) • Junior or Senior year students will be considered • Individual must be self-driven and willing to multi-task in a fast paced environment • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Data analysis and processing experience • Must be a team player • Energized attitude. Preferred Qualifications: • Experience with CAD software such as Solid Works or ProE To learn more, visit our web site at www.sjm.com St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-07 22:20:39United StatesSt. Jude MedicalMinnesotaAF13805MNSt. Paul, MN26992067http://jobs.sjm.com/xml/26992067/jobUSANoneDirect Sales Rep, Cardiovascular Job Requisition #: USD 9483 Date Posted: 03/06/2012 Category: Sales Location: West USA - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Outside sales position calls on physicians, medical laboratories, hospital purchasing agents and administration to sell St. Jude Medical cardiovascular and vascular products in an assigned territory. Position is responsible for professional oversight, territory performance and revenue growth of CVD product line, including capital equipment, disposable, and implantable product lines. Activities include capital selling presentations, preparation and delivery of financial proposals, education of customers on St. Jude Medical CVD products and programs. Experience necessary for building customer relationships to foster product and program practice, particularly for therapy development and development of KOLs (Key Opinion Leaders) who will be experts and advocates of SJM CVD products. Successful skills to drive clinical support for an array of SJM CVD disposable and implantable products. Analytical skills required for territory and account level planning through implementation of company strategies and general sales and service activities. Vital teamwork and communication necessary for the sales position to work in coordination with other SJM sales personnel across SJM product disciplines strategically to optimize overall results. As appropriate, assists marketing personnel on advertising and promotional sales strategies. Requirements/Education: Bachelors degree in a relevant technical field or equivalent and typically four plus years of progressively more responsible sales experience, including experience with both disposable and capital medical equipment. Working knowledge of domestic regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; and familiarity with medical device industry policies, operations and procedures. Documented record of delivering sales/marketing information which adds value to managements decision making process. Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives. Demonstrated strong verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated ability to utilize basic functions from within Microsoft Office including ability develop basic Excel spreadsheets and analysis, basic PowerPoint presentations and Word documents and communications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiology/vascular market and technology. |E-mail this position Submit Resume or C.V.2012-03-06 19:46:51United StatesSt. Jude MedicalNoneUSD 9483NoneVirtual, USA26958029http://jobs.sjm.com/xml/26958029/jobUSANoneField Clinical Engineer, AF Job Requisition #: USD 9503 Date Posted: 03/06/2012 Category: Sales Location: East - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working under general supervision, The Field Clinical Engineer (FCE) is responsible for supporting the EnSite 3000 System sales and marketing process, by providing clinical consultation, teaching and support on the use of the EnSite System and its appropriate application in the clinical setting. To a lesser degree, the FCE is also expected to provide consulting to customers on the complete AF product line. Provides field support for accurate technical support/ troubleshooting, and strategic collaboration with Sales to develop business in the local territory. Works within a small team atmosphere, including Sales Reps, their respective Regional Management, and AF Product Division personnel to develop individual account and territory sales strategies; Performs training and other related logistics coordination and gathers market/customer related feedback to ensure annual operating objectives attained. The FCE participates in the sales and marketing process and is responsible for ensuring all new accounts are established in accordance with St. Judes AF Divisions educational and in-service specific objectives and that ongoing product utilization is encouraged when necessary or requested through in-lab support and consultation with the EP and other lab support personnel. Requirements/Education: Two-year technical degree in a related field, or equivalent. Bachelors degree in Biology/related preferred. Typically a minimum of three plus years of progressively more responsible relevant clinical work experience in cardiology, electro-physiology, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol. Experience with programmable medical devices and software-based medical systems preferred. Must have demonstrated personal computer skills and be able to perform word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management, and customers. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional Health Science certification or designation. |E-mail this position Submit Resume or C.V.2012-03-06 19:46:36United StatesSt. Jude MedicalNoneUSD 9503NoneVirtual, USA26958020http://jobs.sjm.com/xml/26958020/jobUSAMaple GroveProduct Marketing Manager Job Requisition #: 12618 Date Posted: 03/05/2012 Category: Marketing Location: Maple Grove - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Maple Grove. Job Overview The Senior Product Manager is responsible for Transcatheter Aortic Valve Replacement (TAVR) products, including global new product development efforts and supporting the global sales divisions. Responsibilities - Represent Marketing on cross-functional product development teams. - Conduct Voice of Customer (VOC) research and channel findings into product development programs. - Assist in the development of effective sales collateral to support TAVR products. - Develop and maintain product training on key messaging and competitive positioning - Develop KOL strategy for conferences and publications and in managing overall physician relations - Ensure Sales organizations are fully supported and prepared with the knowledge and tools necessary to capitalize on revenue growth opportunities. - Assist with planning and tactical implementation of the company's tradeshow activities (US and International). - Develop appropriate strategies and plans to monitor and respond to changes in the market place. - Provide rapid response to product issues and needs (i.e. competitive intelligence and approvals, clinical, regulatory and legal) Qualifications: - BS/BA in business or heath sciences - MBA preferred - 5+ years in medical device industry, with prior experience in Interventional Cardiology preferred - Ability to work with a cross-functional team and seek consensus/approval where needed - Ability to work independently and take direction from others - Able to help determine product positioning and create promotional/launch programs for our global customers - Strong interpersonal communication skills for both internal and external customers - Basic computer skills: Word, Excel, PowerPoint, etc - Good basic understanding of anatomy, cardiology in particular - Leadership skills in persuasion, building consensus, and a company-wide view of initiatives. |E-mail this position Submit Resume or C.V.2012-03-05 23:41:45United StatesSt. Jude MedicalMinnesota12618MNMaple Grove, MN26938000http://jobs.sjm.com/xml/26938000/jobUSANoneDirect Sales Rep, Cardiovascular Job Requisition #: USD 9494 Date Posted: 03/02/2012 Category: Sales Location: East - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Outside sales position calls on physicians, medical laboratories, hospital purchasing agents and administration to sell St. Jude Medical cardiovascular and vascular products in an assigned territory. Position is responsible for professional oversight, territory performance and revenue growth of CVD product line, including capital equipment, disposable, and implantable product lines. Activities include capital selling presentations, preparation and delivery of financial proposals, education of customers on St. Jude Medical CVD products and programs. Experience necessary for building customer relationships to foster product and program practice, particularly for therapy development and development of KOLs (Key Opinion Leaders) who will be experts and advocates of SJM CVD products. Successful skills to drive clinical support for an array of SJM CVD disposable and implantable products. Analytical skills required for territory and account level planning through implementation of company strategies and general sales and service activities. Vital teamwork and communication necessary for the sales position to work in coordination with other SJM sales personnel across SJM product disciplines strategically to optimize overall results. As appropriate, assists marketing personnel on advertising and promotional sales strategies. Requirements/Education: Bachelors degree in a relevant technical field or equivalent and typically four plus years of progressively more responsible sales experience, including experience with both disposable and capital medical equipment. Working knowledge of domestic regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; and familiarity with medical device industry policies, operations and procedures. Documented record of delivering sales/marketing information which adds value to managements decision making process. Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives. Demonstrated strong verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated ability to utilize basic functions from within Microsoft Office including ability develop basic Excel spreadsheets and analysis, basic PowerPoint presentations and Word documents and communications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiology/vascular market and technology. |E-mail this position Submit Resume or C.V.2012-03-03 00:53:40United StatesSt. Jude MedicalNoneUSD 9494NoneVirtual, USA26905227http://jobs.sjm.com/xml/26905227/jobUSAWestfordSpecialist - Regulatory Affairs Job Requisition #: 12581 Date Posted: 03/02/2012 Category: Regulatory Affairs Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position ensures products and procedures comply with regulatory agencies specifications Essential Functions: • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals. • Prepare PMA supplements for device or manufacturing changes. • Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada. • Prepare appropriate documentation for renewing CE mark certification. • Prepare appropriate documentation for annual renewals submitted to Health Canada. • Prepare Technical Files for product s with self certified CE Marks. • Update Technical Files on annual basis. • Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations. • Act as a core member on development teams, providing RA guidance, and project regulatory assessments. • Interface directly with FDA, Notified Bodies and Health Canada. • Communicate and coordinate regulatory activities with other departments. • Review of product and manufacturing changes for compliance with applicable regulations (Change Control). • Review of protocols and reports to support regulatory submissions. Qualifications: • BA or BS in a technical discipline. • 5+ years regulatory experience preferred • Experience with 510(k) applications, PMA supplements and US device regulations. • Experience with EU and Canadian medical device regulations and submissions. |E-mail this position Submit Resume or C.V.2012-03-03 00:53:20United StatesSt. Jude MedicalMassachusetts12581MAWestford, MA26905226http://jobs.sjm.com/xml/26905226/jobUSALong IslandDir, Regional Sales, CRM Job Requisition #: USD 9498 Date Posted: 02/29/2012 Category: Sales Management Location: Long Island - NY - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has primary management responsibility directly or through subordinates for directing the CRM sales of SJM/USD products and/or services in a specified region or other major geographical area. Exercises direct supervision over Company sales representatives, and acts in a liaison capacity with independent sales rep firms. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems; ensures employee compliance with such policies, practices and procedures. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. May be responsible for processes across Regional or organizational lines. Requirements/Education: A Bachelors degree in Business Administration, Marketing or equivalent. Typically eight plus years of progressively more responsible work experience in Tachycardia/Bradycardia product areas or a related discipline, including direct experience in CRM product sales. Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position. Must be skilled at delegation, follow-up, and team building. Has direct knowledge about physicians in the CRM medical market. Seasoned judgment acquired through organizational experience and achievements applying state-of-the-art sales principles. Documented record of delivering sales information which adds value to managements decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills. Must be able to perform intermediate level arithmetic calculations, including ratios, rates and percentages; draw and interpret graphs; apply the principles of rational systems to solve practical problems; effectively deal with a variety of tangible variables in situations where only limited standardization exists; and interpret a variety of instructions furnished in written, diagrammatic or schedule form. Must have a comprehensive working knowledge of frequently used personal computer programs and applications, such as, e-mail, Microsoft Office, graphics software, etc.. Desired Requirements: An advanced credential in a relevant discipline or concentration. Professional certification or designation. A comprehensive understanding of cardiac rhythm management (CRM) technology. |E-mail this position Submit Resume or C.V.2012-02-29 18:38:23United StatesSt. Jude MedicalNew YorkUSD 9498NYLong Island, NY26838771http://jobs.sjm.com/xml/26838771/jobUSADallasSenior Machine Design Engineer Job Requisition #: NMD3147 Date Posted: 02/28/2012 Category: Engineering Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview The Senior Machine Design Engineer designs, fabricates, and supports automated production equipment. Major, On-Going Responsibilities: • Interface with internal customers to provide mechanical design support for manufacturing and testing equipment • Support the development of automated equipment • Evaluate process and design alternatives based on Design for Manufacturability principles • Establish knowledge base of new developments in manufacturing and design technologies • Interface with vendors on procuring materials, services, and equipment • Troubleshoot new and existing automated equipment • Assemble and evaluate automated equipment • Establishes machine specifications • Support equipment validations Experience and Training: • Bachelor’s degree in Mechanical or Biomedical Engineering • 5-8 years in manufacturing engineering with machine design experience • Experience designing and fabricating automated production equipment for low and high volume processes is required • 2-3 years experience with general automation and control concepts along with machine vision systems and PLC software programming • 2-3 years experience using CAD software (SolidWorks and AutoCAD) • 1-2 years medical device experience strongly preferred • Knowledge of PC applications Other Characteristics: • Skilled verbal and written communicator, possessing the ability to interact well with all levels of the organization • Goal/results oriented • Ability to work independently • Ability to work under pressure and with short deadlines • Ability to multi task various functions and skill sets • Good organizational skills and attention to details |E-mail this position Submit Resume or C.V.2012-02-29 00:30:58United StatesSt. Jude MedicalTexasNMD3147TXDallas, TX26827235http://jobs.sjm.com/xml/26827235/jobUSASt. PaulProduct Manager, Structural Heart Job Requisition #: 12579 Date Posted: 02/28/2012 Category: Marketing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN: Job Overview Identify, develop and execute Product Marketing commercialization plans for Structural Heart Left Atrial Appendage products sold globally. Act as a key interface between our International Customers, our geographic sales teams and the Product Division. Be responsible for the development of specific marketing plans and activities for specific products to establish, enhance or distinguish product placement within the competitive arena. Develop business plans and product positioning in the marketplace. Oversee market research, monitor competitive activity, and identify customer needs. Establish pricing strategies. Interface with engineering, manufacturing, and sales to develop new products or enhance existing products. TYPICAL DUTIES AND RESPONSIBILITIES •Plan and prepare product launches in cooperation with the Product Division /International Marketing and facilitate implementation throughout the geographies. •Evaluate strategies for product launches to ensure products are properly positioned and that brochures, sales sheets and supporting materials will launch products successfully and stimulate sales. •Develop recommendations on translating data collected on customer needs into engineering measures to evaluate product’s performance. •Develop recommendations on appropriate process for new products and on pricing and positioning strategies. •Prepare monthly new product launch updates for assigned products including metrics, strengths, gaps, strategies to close gaps, etc. •Provide analyses that highlight sales opportunities, trends and issues. •Provide rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal) •Contribute to the development of the International Division's annual strategic plan and operating plan •Develop marketing materials outside of new product launches •Develop obsolescence strategy to manage complete product portfolio •Represent the company by visiting accounts in order to solicit feedback on company products and services. •Develop appropriate strategies and plans in order to monitor and respond to changes in the market place, competitors, and performance versus objectives by major geography. •Work with the marketing manager to represent the Global viewpoint in the new product development process. •Determine clear and specific priorities for the development of new products and product enhancements by defining customer needs and working with other internal functional groups. •Rapid response to product issues and needs (e.g. competitive intelligence and approvals, clinical, regulatory and legal). •Contribute toward the development of an annual departmental budget by forecasting future needs, utilizing previous year’s budget, current objectives and budget guidelines. MINIMUM QUALIFICATIONS •Bachelors degree in business, sciences, or nursing required •5+ years marketing experience within Medical Device Industry including market plan development and execution, working effectively in a complex, multi-tasking environment •Previous experience managing multiple, simultaneous new product launches required •5+ years experience using spreadsheets, databases and presentation software •Strong oral and written communication skills, influence management skills and negotiation skills, while remaining sensitive to cultural differences •Strong analytical, strategic and problem-solving skills required •Strong individual self starter who has ability to develop and execute on plans •Strong conflict resolution skills to achieve results through cross functional groups •Strong team player—ability to work as a key member of the International Division marketing team. •Strong leadership skills—ability to function as the marketing lead” on high profile projects around the world •Project management skills—ability to manage complex projects and programs. Ability to pull the appropriate functional and geographic functions together to support initiatives •Ability to distinguish between Objectives, Strategies and Tactics •Knowledge/experience with customer base •Understanding of medical products clinical and regulatory process and environments PREFERRED QUALIFICATIONS •MBA with marketing emphasis preferred •5+ years marketing experience representing EP or Interventional Cardiology products •Previous experience collaborating with international marketing and sales teams TRAVEL REQUIREMENTS: •20-25% to international locations including Europe, Asia Pacific and Japan PHYSICAL DEMANDS/WORK ENVIRONMENT Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position requires significant travel to all international locations of St. Jude business interests outside of the US. |E-mail this position Submit Resume or C.V.2012-02-29 00:30:45United StatesSt. Jude MedicalMinnesota12579MNSt. Paul, MN26827230http://jobs.sjm.com/xml/26827230/jobUSAWestfordEngineer - Quality Job Requisition #: 12565 Date Posted: 02/24/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-27 23:58:45United StatesSt. Jude MedicalMassachusetts12565MAWestford, MA26798151http://jobs.sjm.com/xml/26798151/jobUSAMinnetonkaEngineer - Machine Design Job Requisition #: 12439 Date Posted: 02/24/2012 Category: Operations Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: Design and fabricate automated production equipment. Essential Functions: •Interface with internal customers to provide mechanical design support for manufacturing and testing equipment •Support the development of automated equipment •Evaluate process and design alternatives based on Design for Manufacturability principles. •Establish knowledge base of new developments in manufacturing and design technologies. •Interface with vendors on procuring materials, services, and equipment •Troubleshoot new and existing automated equipment •Assemble and evaluate automated equipment •Establishes machine specifications. •Support equipment validations Qualifications: •Bachelor degree in Engineering or Associates degree in equipment technology with 7-10 years experience •3-5 years experience as machine design engineer •Must have experience with designing and fabricating automated production equipment for low and high volume processes. •Good communication skills and the ability to interact with all levels of the organization •Experience with general automation and control concepts along with machine vision systems and PLC software programming. •CAD software skills are also required (ProE, SolidWorks, and AutoCAD). |E-mail this position Submit Resume or C.V.2012-02-25 18:20:49United StatesSt. Jude MedicalMinnesota12439MNMinnetonka, MN26756358http://jobs.sjm.com/xml/26756358/jobUSASt. PaulMachinist Job Requisition #: 12426 Date Posted: 02/24/2012 Category: Manufacturing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Sets up, calibrates, and operates metal fabricating equipment. Essential Functions: •Set up, calibrate, and operate machining equipment used to produce or modify parts or products. •Inspect machining operations and finished product against specified tolerances using precision measuring tools. •Determine and correct minor machine malfunctions. •Perform routine maintenance and cleaning on machines and equipment Qualifications: • Two year technical degree in Machining or 5 years experience in a machine shop required |E-mail this position Submit Resume or C.V.2012-02-25 18:20:34United StatesSt. Jude MedicalMinnesota12426MNSt. Paul, MN26756357http://jobs.sjm.com/xml/26756357/jobUSASt. PaulMachinist Job Requisition #: 12427 Date Posted: 02/24/2012 Category: Operations Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Sets up, calibrates, and operates metal fabricating equipment. Essential Functions: •Set up, calibrate, and operate machining equipment used to produce or modify parts or products. •Inspect machining operations and finished product against specified tolerances using precision measuring tools. •Determine and correct minor machine malfunctions. •Perform routine maintenance and cleaning on machines and equipment Qualifications: • Two year technical degree in Machining or 5 years experience in a machine shop required |E-mail this position Submit Resume or C.V.2012-02-25 18:20:34United StatesSt. Jude MedicalMinnesota12427MNSt. Paul, MN26756356http://jobs.sjm.com/xml/26756356/jobUSAWestfordSr. Electrical Engineer - Research & Development Job Requisition #: 12357 Date Posted: 02/23/2012 Category: Research Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Senior Electrical Engineer PRIMARY DUTIES AND RESPONSIBILITIES: We are seeking an enthusiastic, creative, and hard-working engineer with a strong theoretical background in electrical engineering, as well as demonstrated experience in instrumentation/systems development. The successful candidate will serve as an R&D engineer in a small group focused on developing the next generation of intraluminal imaging systems for cardiovascular applications. EXPERIENCE & SKILL REQUIREMENTS: • Development of opto-electronic signal processing and high-speed mixed signal/RF circuit designs. • Experience with low noise/wide bandwidth circuits, high speed A/D, D/A, µC, and switching power supply design. • Development of specifications & schematics, supervision of board layout process, management of prototype fabrication, development of test methods and performance of design qualification testing, support of production transfer including development of production test methods. QUALIFICATIONS: Required: • Bachelor's Degree in Electrical Engineering with 8+ years of experience • Experience with complex system architectures Desired: • Prior experience working in medical device development • Demonstrated technical leadership on a relevant project • Experience in Telecom, OCT, ultrasound or other imaging modalities • Experience with Altium Designer |E-mail this position Submit Resume or C.V.2012-02-24 03:31:44United StatesSt. Jude MedicalMassachusetts12357MAWestford, MA26719418http://jobs.sjm.com/xml/26719418/jobUSASt. PaulEngineer - Manufacturing Job Requisition #: 12568 Date Posted: 02/23/2012 Category: Manufacturing Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Sr. Manufacturing Engineer Duties and Responsibilities: Support and optimize the manufacturing, packaging & sterilization of a tissue valve product line. Manage projects which may include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians. Additional responsibilities include: •Support current production with root cause investigation and non conforming material reviews • Provide technical mentorship to engineers and technicians •Conduct Process FMEAs and Process Validations •Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts •Coordinate the design, procurement, build and debug of tooling, machinery and test equipment •Work with Product Development to ensure Design for Manufacturability Individual should: •Be innovative, resourceful, and work with minimal direction •Have excellent organization, problem solving, communication, and team leadership skills •Work effectively with cross-functional teams Qualifications: • Chemical, Mechanical or any engineering or technical degree required •5+ years manufacturing engineering experience •Medical device experience is highly preferred •International manufacturing experience preferred •Strong analytical, problem solving skills •Demonstrated leadership capability in team settings •Six Sigma certification preferred •<25% travel required |E-mail this position Submit Resume or C.V.2012-02-24 03:31:36United StatesSt. Jude MedicalMinnesota12568MNSt. Paul, MN26719384http://jobs.sjm.com/xml/26719384/jobUSASt. PaulSenior Manager - Operations Engineering Job Requisition #: 12570 Date Posted: 02/23/2012 Category: Engineering Operations Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Senior Manager - Engineering Operations Duties and Responsibilities: This position will support the development, improvement and the sustaining of a project management system for new and existing product lines and value streams. In addition, it will support the continuous improvement and optimization of tissue heart valve product lines. It will also require managing engineering projects which may include new production equipment, process improvements and cost reductions. Provide guidance to engineers and technicians in both a direct and in direct reporting relationship. Additional responsibilities include: •Support current production with root cause investigation and non conforming material reviews • Provide technical mentorship to engineers and technicians •Establish lean project management tools and skill sets within the organization •Coordinate the design, procurement, build and debug of tooling, machinery and test equipment • Mentor individuals in the organization to improve their project management skill sets and drive results through active management and continuous improvement methodologies • Foster a positive and robust working environment through positive relationships and constructive feedback Individual should: •Be innovative, resourceful, and work with minimal direction •Have excellent organization, problem solving, communication, and team leadership skills •Work effectively with cross-functional teams Qualifications: • Chemical, Mechanical or any engineering or technical degree required •10+ years manufacturing engineering and operations experience • Strong analytical, problem solving skills • Demonstrated people management skills and leadership capability in team settings • Medical device experience is highly preferred •International manufacturing experience preferred •Six Sigma certification preferred •25% travel required |E-mail this position Submit Resume or C.V.2012-02-24 03:31:36United StatesSt. Jude MedicalMinnesota12570MNSt. Paul, MN26719383http://jobs.sjm.com/xml/26719383/jobUSASunnyvaleClinical Product Surveillance (CPS) Analyst Job Requisition #: 12524 Date Posted: 02/22/2012 Category: Clinical Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under the general direction of the department manager while demonstrating a high degree of discretion and independent judgment, is accountable for the professional medical analysis and validation of product surveillance documents, medical device reports (MDRs), and customer letters. Analyzes customer inquiries to ensure company responses are medically appropriate and include relevant, accurate, and thorough technical, clinical, and educational information while communicating directly with the customer. Makes recommendations to management based on these analyses. Reviews and validates product surveillance documents and medical device reports for patient safety and product efficacy. Stays abreast of and communicates developments to ensure that product surveillance files comply with U.S. Food and Drug Administration (FDA) regulations as well as company policy. Requirements/Education: Bachelors of Science Degree in Nursing (BSN) and a current nursing license or BME degree. A minimum of four plus years of relevant experience in clinical risk analysis/or technical support in the cardiac pacing industry, or equivalent. Candidate must demonstrate strong written and oral communication skills. Demonstrated ability to understand, interpret, and comply with US Food and Drug Administration (FDA) regulations and Company operating procedures. Must be able to demonstrate the ability to read and interpret medical reports as well as product documentation. Candidate must possess demonstrated organizational skills, professional and business judgment, sound decision-making and problem-solving abilities, discretion, and excellent organizational skills for managing multiple ongoing tasks. Candidate must be able to meet deadlines on multiple projects. Must be detail- and team-oriented and be able to function independently in a busy department while working with cross-functional teams and providing support to other team members. Must possess demonstrated personal computer literacy and proficiency with standard software applications, including Excel, Word or equivalent applications are required. Must be able to demonstrate the ability to read and interpret medical reports as well as product documentation. Desired Requirements: An advanced degree in a relevant discipline. Knowledge of cardiac anatomy/physiology and/or cardiac pacing/defibrillation systems from a clinical perspective is desired. RN with background in Cardiac Electrophysiology is preferred. |E-mail this position Submit Resume or C.V.2012-02-22 22:00:35United StatesSt. Jude MedicalCalifornia12524CASunnyvale, CA26691993http://jobs.sjm.com/xml/26691993/jobUSAPlymouthSenior Clinical Auditor Job Requisition #: 12534 Date Posted: 02/21/2012 Category: Compliance Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Senior Clinical Auditor will be a member of the Clinical Quality Assurance department within the St. Jude Medical (SJM) CVD Clinical Affairs. The primary responsibility is to implement and maintain written clinical procedures and systems that include a global perspective of medical device clinical trials and quality systems. Responsibilities: • Perform clinical audits • Manage and archive projects and documents • Communicate with St. Jude Medical departments and operations • Ensure clinical investigations are designed, conducted and monitored to comply with applicable global requirements • Train and educate personnel with proper interpretations of regulations and clinical systesm • Represent St. Jude Medical during agency and/or government inspections for clinical research Requirements: • Bachelor's degree preferred; additional relevant work experience in lieu of degree is acceptable. • 5 yrs experience in Clinical Compliance, Regulatory and/or Clinical Affairs departments in FDA regulated company • Ability to understand clinical trial activities or have experience conducting clinical trial activities • Strong understanding and knowledge of the global medical device regulations that interact with clinical trial activities • Excellent organizational, interpersonal, and communication (verbal/written) skills • Computer proficiency in Microsoft Office applications, to include spreadsheet/graphics programs • Extensive working knowledge of national and international practices, guidance, standards and regulations • Ability to constructively interact with a range of personalities and positions, both inside and outside the organization • Ability to travel up to 50% |E-mail this position Submit Resume or C.V.2012-02-21 21:41:32United StatesSt. Jude MedicalMinnesota12534MNPlymouth, MN26658163http://jobs.sjm.com/xml/26658163/jobUSAWestfordEngineer II - Quality Job Requisition #: 12344 Date Posted: 02/21/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within remanufacturing/Service Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-21 21:40:43United StatesSt. Jude MedicalMassachusetts12344MAWestford, MA26658112http://jobs.sjm.com/xml/26658112/jobUSASt. PaulIntellectual Property Attorney II Job Requisition #: AF13796 Date Posted: 02/17/2012 Category: Legal Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview The Atrial Fibrillation division is seeking a high-caliber Intellectual Property Attorney for an opening in our growing legal department. The successful candidate will work directly with the research and development group and the technology development group as a key member of the legal team. Essential Functions: • Collect, screen, and manage invention disclosures. • Conduct meetings with inventors to review invention disclosures. • Prepare and prosecute patent and trademark applications. • Participate in due diligence initiatives as they relate to intellectual property. Analyze competitors’ intellectual property portfolios and products. • Assist with patent clearance activities for new products/services, and formulate non-infringement and invalidity positions as necessary. • Help manage outside counsel, including the oversight of work. • Assist outside litigation counsel with intellectual property litigation. • Educate employees as to the protection of innovations through the patent process, best practices for maintaining confidential business information, contractor and vendor matters, and the overall development of intellectual property assets. • Assist with developing electronic and hardcopy training materials and give presentations on substantive legal areas related to intellectual property. • Draft technology agreements, including, research and development agreements, confidentiality agreements, license agreements, and consulting agreements. Required Qualifications: • Juris Doctor or Bachelor of Laws degree from accredited law school. • Degree in Engineering or Science. • Admission to, or eligibility for admission to, the state bar of Minnesota. • Minimum of seven years post-law-school experience with progressively more responsible work experience in prosecuting mechanical and/or electro-mechanical patent applications with regionally or nationally recognized law firm and/or corporation. Experience counseling clients with their patent, trademark, and copyright issues. • Well-developed written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills. • The ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. • Ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. • Registered to practice before the United States Patent & Trademark Office (USPTO). Preferred Qualifications: • Master's degree in science or engineering. • Applied legal experience in the medical devices, biomedical, or related industries. |E-mail this position Submit Resume or C.V.2012-02-17 20:54:58United StatesSt. Jude MedicalMinnesotaAF13796MNSt. Paul, MN26599535http://jobs.sjm.com/xml/26599535/jobUSASt. PaulMechanical Engineer I Job Requisition #: AF13791 Date Posted: 02/16/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview Impact this role will have within the AF division: • Production support and process validation • Troubleshoot manufacturing process and equipment • Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput • Protocol and report writing • Generate and modify manufacturing systems and processes • Work with cross functional teams • Develop and implement process improvements Required Qualifications: • Bachelor’s degree in Mechanical or Industrial Engineering • 0-2 years engineering experience • Strong analytical, problem solving and project management skills • Highly motivated with a demonstrated track record of achievement • Solid communication skills • Statistical data analysis experience • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Medical device experience • Manufacturing experience |E-mail this position Submit Resume or C.V.2012-02-16 19:29:43United StatesSt. Jude MedicalMinnesotaAF13791MNSt. Paul, MN26571349http://jobs.sjm.com/xml/26571349/jobUSALos AngelesCo-op Job Requisition #: 12289 Date Posted: 02/16/2012 Category: CO-OP Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Co-op Summary The Co-op (i.e., Co-operative Education) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Qualifications Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the students university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. Electrical Engineering Students - July - December Please only apply if you can work the 6 months - this is not an internship. |E-mail this position Submit Resume or C.V.2012-02-16 19:29:34United StatesSt. Jude MedicalCalifornia12289CALos Angeles, CA26571300http://jobs.sjm.com/xml/26571300/jobUSAPlymouthClinical Programs Manager Job Requisition #: 12409 Date Posted: 02/13/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Programs Manager will manage the successful completion of all clinical programs. Responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions. Responsibilities: Manage the successful and timely execution of all device clinical trials Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations Responsible for the training, initiation and management of clinical trial sites Establish and manage trial budgets including enrollment targets Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending Participate in the design and development of new trials Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis Develop and maintain individual training programs for all staff Able to assist in the drafting and development of publications based on the results of the clinical trials Develop and maintain strong relationships with principal investigators at clinical trial sites Travel estimated at15% Requirements: BA/BS in life sciences or nursing 10+ years experience in clinical research 5+ years experience successfully managing a team of clinical research professionals 5+ years clinical research experience in medical device Demonstrated knowledge of and experience with GCP and all US regulations Hands on experience in IDE clinical trials and the preparation of PMAs Comfortable in both the clinical and business setting Comfortable presenting to senior management Ability to work independently and take direction from others Strong work ethic Excellent communication, problem-solving and organizational skills Computer proficiency including Microsoft Office applications Preferred Qualifications: Advanced degree in life sciences or nursing a strong plus Experience in the cardiovascular therapeutic areas |E-mail this position Submit Resume or C.V.2012-02-13 22:34:16United StatesSt. Jude MedicalMinnesota12409MNPlymouth, MN26501390http://jobs.sjm.com/xml/26501390/jobUSAAustinSr. Interactive Specialist Job Requisition #: USD 9472 Date Posted: 02/12/2012 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview The Sr. Specialist will execute upon the interactive marketing communication strategy for the United States sales force and customer group, working within the following channels: iPad apps, multi-media assets, SJM websites, eNewsletters, and social media efforts. Essential functions include spearheading interactive projects which fit into a broader communication plan, develop a project roadmap which includes documenting the strategy and coordinating the budget, timeline, content, design, technical development, deployment and education/training for every project. Work with SME on visual design, structural IA and navigation, identifying content needs, uploading content to the CMS and routinely updating apps with new material, providing regular usage reporting and fielding feedback for continuous improvement. Requirements/Education: A Bachelors degree in Public Relations, Journalism, Advertising, Communications or equivalent plus at least five years of progressively more responsible experience in the communications field, specifically in Sales/Marketing focused organizations. Must be able to effectively work with both IT and external development teams on technical issues and with marketing for strategic and functional enhancements. Applicants should be able to show a steady growth and increase in responsibilities, leadership and mentoring of colleagues, as well as demonstrated successes. Knowledge of regulated industries, ideally cardiology, neurology and/or medical devices is required. The applicant will need to have a positive and hard-working attitude and exhibit strong, collaborative leadership skills. This highly organized individual must be able to manage multiple projects at once, prioritize and maintain a busy schedule and meet deadlines and must embrace challenges, some ambiguity, and apply creative-thinking to all projects in order to be successful. Desired Requirements: Advertising agency and corporate marketing experience. Healthcare marketing background. Please include a Cover Letter and Resume when applying. |E-mail this position Submit Resume or C.V.2012-02-13 22:34:05United StatesSt. Jude MedicalTexasUSD 9472TXAustin, TX26501381http://jobs.sjm.com/xml/26501381/jobUSASt. PaulEngineer - Controls Job Requisition #: 12438 Date Posted: 02/10/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview Position Summary: Design and fabricate controls systems for automated production equipment. Essential Functions: •Work with manufacturing engineers, technicians, and maintenance in designing and providing manufacturing support and training for automated equipment •Demonstrate organization, problem solving, communication, and team leadership/participation skills •Evaluate process and design alternatives based on Design for Manufacturability principles •Establish machine specifications based on customer requirements •Design control systems and develop and test software •Work with systems that range in scope from stand alone PLC and HMI systems to multi-component, multi-user process control systems often with interface to Corporate databases •Program and integrate PLCs and HMIs using the following hardware/software: Allen Bradley, Acroloop, Cognex, DVT, Parker Compumotor, Keyance, .NET, Visual basic, VBA •Ensure projects meet operating expectations and are completed within authorized budgets and schedule constraints •Establish knowledge base of new developments in manufacturing and design technologies •Interface with vendors on procuring materials, services, and equipment •Troubleshoot new and existing automated equipment •Assemble and evaluate automated equipment •Support equipment validations Qualifications: •Bachelor degree in Engineering or equivalent years of relevant experience •5+ years experience as controls/software engineer •Machine Vision Engineer specialty may substitute relevant skills and experience with Machine Vision Integration for specific machine control hardware and programming requirements (refer to attached). •Must have experience with designing and fabricating automated production equipment •Experience with machine and automation development practices, controller design, vision systems, PLC software programming, and CAD software is also required depending on job focus Controls, Software, or Machine Vision Engineering) |E-mail this position Submit Resume or C.V.2012-02-10 23:22:04United StatesSt. Jude MedicalMinnesota12438MNSt. Paul, MN26467982http://jobs.sjm.com/xml/26467982/jobUSAWestfordTechnical Writer Job Requisition #: 12298 Date Posted: 02/10/2012 Category: Technical Publications Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Primary Responsibilities: Creates, develops, organizes, plans, writes, illustrates, and edits operational, maintenance, and other electronic or printed publications for company products. Researches engineering schematics, technical design specifications, diagrams, and specifications with design engineers, users, and other staff. References hands-on experience with the equipment. Coordinates the layout and organization of manuals. Acquires and organizes basic source material, including applicable specifications, engineering specifications and drawings. May document processes and specifications. Recommends effective formats and produces products that conform to company standards. Know Software Although the software will vary, technical writers will need to be familiar with software. At a minimum, they will use word processing software such as Microsoft Word. The second most common tool is desktop publishing software such as In Design or Quark. Image editing tools such as Photoshop and Illustrator are also important. Gather Technical Information Although technical writers may not have an understanding of the technical information in the company, they must be able to research this information and communicate it appropriately to their intended audience. Interact with Subject Matter Experts Technical writers work closely with subject matter experts, such as engineers, to ensure accurate information in the documentation and to give appropriate feedback concerning product improvements. Lay Out Documents Must have an understanding of design principles to lay out the documents in an appealing way. May assist and/or provide limited support to others creating documents in the company. EXPERIENCE & SKILL REQUIREMENTS: •Bachelor’s degree and 3+ years of experience •Develops documentation to resolve complex problems very often requiring creativity • Write procedures, help menus, or describe interface interactions • Prior work with Language translations • Framemaker experience • Candidate must be able to work independently or in a team. • Previous experience in a medical device company preferred • Good organizational and follow-up skills • Ability to interface with technical groups in the organization |E-mail this position Submit Resume or C.V.2012-02-10 23:21:59United StatesSt. Jude MedicalMassachusetts12298MAWestford, MA26467969http://jobs.sjm.com/xml/26467969/jobUSAPlymouthClinical Programs Manager Job Requisition #: 12506 Date Posted: 02/10/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions. Responsibilities: • Manage the successful and timely execution of all device clinical trials • Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations • Responsible for the training, initiation and management of clinical trial sites • Establish and manage trial budgets including enrollment targets • Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending • Participate in the design and development of new trials • Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis • Develop and maintain individual training programs for all staff • Able to assist in the drafting and development of publications based on the results of the clinical trials • Develop and maintain strong relationships with principal investigators at clinical trial sites • Ensure that St. Jude Medical is using the most current tools in the management of clinical trials • Travel estimated at 30% Requirements: • BA/BS in life sciences or nursing • 10+ years experience in clinical research • 5+ years experience successfully managing a team of clinical research professionals • 3-5 years clinical research experience in medical device PREFERABLY • Demonstrated knowledge of and experience with GCP and all US regulations • Hands on experience in IDE clinical trials and the preparation of PMAs • Comfortable in both the clinical and business setting • Comfortable presenting to senior management • Ability to work independently and take direction from others • Strong work ethic • Excellent communication, problem-solving and organizational skills • Computer proficiency including Microsoft Office applications Preferred Qualifications: • Advanced degree in life sciences or nursing a strong plus • Knowledge and experience with European and Japan device clinical trials a strong plus • Experience in the cardiovascular therapeutic areas |E-mail this position Submit Resume or C.V.2012-02-10 23:21:31United StatesSt. Jude MedicalMinnesota12506MNPlymouth, MN26467931http://jobs.sjm.com/xml/26467931/jobUSAPlymouthClinical Research Associate II Job Requisition #: 12425 Date Posted: 02/07/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department. Responsibilities: • Follows department Standard Operating Procedures • Sets up sites: clinical research agreements, IRB Approvals, etc • Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations • Assists Regulatory in annual report and progress reports to the FDA • Organizes Investigator and Data Safety Monitoring Board meetings • Reviews data forms and DCF generation • Conducts field audits to assure protocol compliance and data integrity • Generates presentations when requested by investigators of AGA personnel • Generates follow-up reminder reports and sends to investigators or AGA personnel • Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries • Acquires professional, product and market expertise via independent reading, networking and training • Counsels and trains newly hired CRAs and monitors • Travels approximately 20% • Participates in professional activities outside of normal business hours • Performs other related duties as requested Requirements: • BA/BS in business, science or nursing • 2 - 4 years experience in clinical research including monitoring • Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization • Excellent written and verbal communication skills • Ability to work independently and take direction from others |E-mail this position Submit Resume or C.V.2012-02-08 07:39:11United StatesSt. Jude MedicalMinnesota12425MNPlymouth, MN26394667http://jobs.sjm.com/xml/26394667/jobUSANoneManager, Patient Therapy Access Job Requisition #: USD 9431 Date Posted: 01/18/2012 Category: Health Policy and Reimbursement Location: Northeast - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview This position will support the Northeast and can be located anywhere along the East Coast. The St. Jude Medical Patient Therapy Access Manager for neuromodulation therapy maintains key strategic relationships between Marketing, Clinical and Sales Management. Provides expertise in understanding the reimbursement landscape related to Medicare, managed care customer and reimbursement/legislative changes that could impact existing and future products. Responsible for monitoring payer coverage and payment policies for assigned neuromodulation and competitor products in the defined therapeutic area and across the assigned Medicare Regional Carriers and Fiscal Intermediaries; identifying relevant regional/local health care coverage opportunities and threats; and researching and resolving reimbursement issues identified by the customers and/or NMD sales/account teams. The Patient Therapy Access Area Manager will be an expert in local and regional private/government payer policies and will assist existing and emerging customers in all aspects of billing and coding to ensure that patients are provided easy access to company products. Major, On-Going Responsibilities: • Provide appropriate coding and billing guidance - Establish relationships with internal and external customers to optimize strategy for individual accounts. Participate in pre-sales activities with sales representatives, prospective and existing customers in order to support positive reimbursement outcomes. Timely and accurate response to all reimbursement questions regarding billing for company products. Assist accounts in identifying claims and process changes to appeal or re-bill claims. Investigate all denied or partially paid services with accounts and case managers and follow -up with stakeholders and account regarding next steps and support needs. Keep current on industry reimbursement requirements, changes and policies. • Territory Management - Responsible for development goals, territory business plan, monthly activity reports, expense reports and other reports as required. Complete assignments/projects as directed. Through travel within assigned geographical area of responsibility demonstrate excellent organizational/planning and time management skills. Meet or exceed the standard level of performance in target account activity. • Provide sales support and reimbursement assistance to customers and sales representatives; track and report on trends within territory; assist team members with coding, coverage or reimbursement resolutions, appeals for authorization and payment. Maintain high level of customer support. • Collaborate within the Patient Therapy Access Department to achieve business plan and objectives. Develop and maintain a expert understanding of the regional and local issues through research of local carrier and payer websites, face-to-face meetings with key stakeholders in the assigned Medicare carriers, and opinion leading physicians in the assigned region and therapeutic area(s). • Develop and maintain relationships with Carrier Medical Directors, Office Management Groups and Pain Management Societies to ensure products are utilized and reimbursed. Experience & Training: • Minimum 3-5 years healthcare coding, coverage and reimbursement experience with medical device, pharmaceutical or biotechnology industries. Proven expertise in medical coding, billing processes and claim submissions to public and private insurers for biotechnology products, medical devices and pharmaceuticals. Familiarity with appropriate coding terminology and processes (CPT, HCPCS, ICD – 9, Revenue Codes, DRG etc), coverage and reimbursement. • Must have previous experience working with billing and medical claims personnel in various healthcare settings including. • Experience reviewing health insurance forms (UB-92, CMS-1500, Explanation of benefits, prior authorization of forms, etc), and provider encounter forms (superbills/charge tickets) to troubleshoot cases where billings, claims submission or documentation errors may occur. • Must have strong understanding of Medicare Part A & B, and legislative/policy issues as it relates to reimbursement. • Computer proficiency, e.g., programs such as MS Word, Excel, Outlook and other computer programs • Excellent interpersonal and communication (oral and written) skills; ability to interact with key influencers and build strong relationships • Excellent problem-solving and project management skills • Ability to thrive in a team environment and achieve objectives in a cross-functional setting. • Self-directed; ability to work independently Ability to travel 75% of the time and cover geographic area of ME, NH, VT, CT, MA,NY, NJ, DC, MD |E-mail this position Submit Resume or C.V.2012-02-08 07:38:49United StatesSt. Jude MedicalNoneUSD 9431NoneVirtual, USA26394641http://jobs.sjm.com/xml/26394641/jobUSAAustinMgr, Product Marketing, Cardiology Job Requisition #: USD 9463 Date Posted: 02/06/2012 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has primary management responsibility for developing and implementing systems, services and programs that will produce maximum results from targeted sales and marketing processes. Has a primary responsibility to ensure that specific marketing initiatives within Cardiovascular Product Division are aligned, implemented, and recorded as sales initiatives across all functional aspects within USD, with a specific emphasis on Optical Coherence Tomography and accessory product lines. Has collateral responsibility to identify opportunities to build sales in under-serviced markets, both current and future. Has responsibility for support to Product Division Marketing regarding product design, product development and ongoing product engineering. Has responsibility for the design and implementation of product-defined sales and manpower metrics with respective application to USD management. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. 1. Works within a matrix, among USD sales management, to apply professional skills in support of the successful promotion of specific SJM products, feature sets, or services, as conducted by the USD field organization. 2. Works within a matrix, among USD sales management, to support sales and marketing management focus upon timeline-based sales and marketing initiatives relative to achieving specific product sales goals. 3. Determines customer needs related to product knowledge and benefits offered by SJM products as a result of direct interface with SJM product end users: physicians, RNs etc. 4. Assists Product Division Marketing in implementing product launch strategies; in particular those launches associated with timeline dependent behaviors, tiered marketplace strategies, new clinical indications that require intensified focus on the part of USD. 5. Provides feedback into Product Marketing regarding marketing initiative content acceptance/utility within USD. 6. Participates and implements marketing goals for increased penetration of Optical Coherence Tomography and accessory product usage within the interventional cardiology and radiology marketplace. 7. Develops and manages key thought leader relationships within the interventional cardiology and radiology marketplace, specifically related to Optical Coherence Tomography and customer training and marketing opportunities. 8. Manages resources, tools, educational events and tracking mechanisms for selected new product launches to the US Cardiology and Radiology marketplace. 1. Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. 2. Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. 3. Performs related functions and responsibilities, on occasion, as assigned. Qualifications: Required: A Bachelor’s degree in Business Administration, Marketing or equivalent plus typically five plus years of progressively more responsible business experience in a medical device company or equivalent, including product or market management experience. Seasoned judgment acquired through organizational experience and a demonstrated record of achievements in successfully building a business. A substantive knowledge of the interventional cardiology, health care delivery, and managed care/reimbursement markets and the factors that drive them is required. A thorough understanding of product and market management, physician, and patient marketing is also required. Demonstrated ability to effectively prioritize development projects using customer input. Requires the ability to track financial metrics and make appropriate adjustments to successfully achieve revenue/unit goals. Documented record of delivering marketing information which adds value to management’s decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills; the ability to lead a cross-functional team. Demonstrated working knowledge of frequently used personal computer programs and applications, such as, Microsoft Office. Must be adept at handling multiple assignments and accomplish these projects within budgetary guidelines. |E-mail this position Submit Resume or C.V.2012-02-06 21:22:37United StatesSt. Jude MedicalTexasUSD 9463TXAustin, TX26341876http://jobs.sjm.com/xml/26341876/jobUSAWestfordMicrobiologist Job Requisition #: 12330 Date Posted: 02/02/2012 Category: Microbiology Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device. Essential Functions: • Provides Facility Microbiological Support o Record review of routine microbiological test results o Routine release of manufactured product o Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods. o Handles routine out of specification test results. o Begins understanding of data analysis of sterilization processes. o Participate in audits of sterilization, test lab, and biological product vendors. • Documentation o Ensures correct documentation linkage flow for microbiologically related documents. o Writes new or updates current microbiologically related documents. • Maintains understanding of applicable standards and applies them to qualifications and test methods. • Writes protocols and reports for qualifications for sterilization and microbiological test methods. o Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation. • Technical Training o Provides training to laboratory technicians on new equipment or new test procedures. o Provides training in the areas of sterilization validation and sterilization processes. • Other Projects as Directed by Department Manager. Qualifications: • Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology. • Two to three years in a medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled). • Two to three years in microbiology and/or sterilization • Person in this position demonstrates professional skills • Articulates technical concepts well • Excellent written communication |E-mail this position Submit Resume or C.V.2012-02-02 18:22:16United StatesSt. Jude MedicalMassachusetts12330MAWestford, MA26274278http://jobs.sjm.com/xml/26274278/jobUSALos AngelesServer Administrator, Senior Job Requisition #: 12332 Date Posted: 02/01/2012 Category: Information Services Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Server Administrator, Sr Summary Working without appreciable direction, oversees, operates and coordinates large multi-tier systems, typically operational 24x7 basis with global users, and typically comprised of multiple technologies. Integrates multiple Information Technology (IT) technologies for delivery of system services. Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. Work requires the application of technical as well as business principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Implements St. Jude Medical Cardiac Rhythm Management Division (SJM/CRMD) and IT specific policies, practices and procedures to accomplish assignments and resolves a broad range of issues and problems. Performs special assignments and projects as directed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Assures that quality of services meets requirements. Remains current on developments in field(s) of expertise. Qualifications Requirements/Education: Requires a Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of technical experience in server, network or system operations including direct experience in a medium sized server environment or larger. Must possess demonstrated knowledge and application of advanced concepts and practices in two or more server operating systems, server hardware, file system concepts and management. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, network, storage/SAN, system backups, security, telephony, Internet-based infrastructure, public facing systems). Demonstrated knowledge of and experience with integration of storage, data communications/ networking, and security implementation. Good oral and written interpersonal, communication skills to deliver customer-focused service. Excellent analytical, presentation, and organizational skills and the ability to meet multiple deadlines and work independently. Must be able to manage an assignment from start to completion; must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Ability to use discretion and handle sensitive/confidential information. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. Must also have demonstrated effectiveness in the expeditious execution of IT transactions and the ability to work with clients as a strategic business partner. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MCSE) and/or Cisco Networking certifications. Ability to program in an administrative language (e.g., Perl, shell scripting). Specific Job Skills Solid experience required with Microsoft Active Directory, Exchange Server 2010 and 2003, Microsoft clustering, Microsoft Certificate Authority, Internet security, transport protocols, server and infrastructure operations. Knowledge of interoperability in heterogeneous environment and system process automation is critical. Demonstrated experience with implementation of multi-tier applications required in medium to large-scale environment (250-1000 servers). Candidates with knowledge of multiple hardware platforms (HP and IBM) are preferred. Experience desired with high availability technologies, storage (EMC/NetApp/ NAS/SAN CIFS), support of database services, Symantec Netbackup, and Active Directory and authentication for public facing applications in a corporate environment. Candidates who have experience with multiple OS or technical skill sets are preferred. Must be a team player with excellent oral and written communication skills. |E-mail this position Submit Resume or C.V.2012-02-02 18:22:16United StatesSt. Jude MedicalCalifornia12332CALos Angeles, CA26274276http://jobs.sjm.com/xml/26274276/jobUSAMinnetonkaSupply Chain Manager Job Requisition #: 11735 Date Posted: 02/01/2012 Category: Purchasing Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Cardiovascular Division: Job Overview Summary: Provide leadership to the Supply Chain organization and ensure business service level objectives are met. Coordinate and oversee key supply chain planning functions: demand planning, launch planning, master data maintenance, capacity planning, production execution, inventory target management, and capacity allocation. This position will serve as the key point of contact for Operations, R&D, and Clinical supply chain activities. Analyze economics of inventory investments to attain the highest service levels with lowest inventory investment. Develop and implement supply chain business process improvements. Duties and Responsibilities: Manage worldwide finished goods inventories using best practice supply chain replenishment methodologies. Deliver accurate forecasts by partnering with Marketing and geographies that set the stage for existing business, new product launches, or distribution channel changes. • Continual focus upon reducing costs and improving inventory turnover and customer service levels • Diagnose inventory overages and shortages. Execute plan to maintain target inventory levels. • Generate production plans necessary to achieve business operating plans and provide for production efficiency while maintaining service level objectives • Analyze new product launch requirements to determine optimal inventory management strategy • Manage stores inventory levels, inventory integrity, and the consumption / replenishment process. • Monitor production flows to ensure timely production, shipping, and receipts • Communicate, maintain, and enhance supply chain performance metrics and ensure all supply chain performance metrics are achieved including service level, timely work orders, inventory turns, and target inventory levels. • Build a high performing team by demonstrating the ability to attract, develop, and retain high potential employees • Responsible for ERP master data accuracy and maintenance. Establish demand requirements and provide leadership to the plant execution functions. • Responsible for developing strategic and operational plans and for coordinating supply chain activities in support of business objectives. • Execute the Sales and Operations Planning Process • Develop continuous improvement efforts which promote supply chain efficiency and business profitability • Work with program management and engineering throughout product life cycle to identify and implement supply chain strategies which support product and process cost improvements, lead time reductions and internal inventory optimization. Education, Experience, Personal and Technical Skills: • BS in Materials Management, Business, Finance or a related field. MBA preferred. • 5+ years of related DRP, MRP with a minimum of 3 years in a supply chain managerial role. • Must understand integrated supply chain and logistic concepts and have solid analytical skills. • Must be a very hands on manager, highly skilled in MRP, DRP, Advanced Excel, Access, • Demonstrated project management experience. • Excellent written and verbal communication skills. • Must have solid multitasking ability and work independently and take direction from others. • Ability to constructively interact with a range of personalities and positions, both inside and outside the organization. • Medical device experience and familiarity with SAP ERP experience preferred. • LEAN and/or Six Sigma experience required. |E-mail this position Submit Resume or C.V.2012-02-01 18:39:03United StatesSt. Jude MedicalMinnesota11735MNMinnetonka, MN26244547http://jobs.sjm.com/xml/26244547/jobUSAWestfordTraining and Development Specialist Job Requisition #: 12293 Date Posted: 01/25/2012 Category: Training Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position works closely with Westford business leaders and other CVD HR training and development personnel to identify employee development needs and organizational training opportunities. Essential Functions: • Develop and implement production training assessment instruments, course content, and certifications, and maintain the certification system. • Proven experience with delivering training programs and/or workshops. • Partner with business leaders and other CVD HR team members to define and maintain accurate training requirements for Westford positions. • Oversee and maintain the Learning Management System (LMS) for Westford employees, including training records management, development and implementation of on-line courses, and system updates. • Utilize the LMS to generate training compliance reports, and partner with Westford leaders to ensure 100% completion of employee training requirements. • Partner with business leaders and other CVD HR team members to design, develop, and facilitate/deliver skills-based and other training programs as needed. • Develop learning tools and training materials using digital photography, digital video and word processing skills. • Other duties as assigned by supervisor. Qualifications: • Bachelor’s degree in Human Resource Development, Technical/Industrial Education or related field. • 4 + years in a technical training development role to include training facilitation and delivery. • Must be computer proficient with proven advanced capabilities in Microsoft Word and experience with Excel and Access databases • Must be proficient with digital camera and technical photography • Must be able to manage training development projects and create collaborative relationships with Engineering and Manufacturing work teams • Must be detail oriented, self-motivated, and have good communication skills |E-mail this position Submit Resume or C.V.2012-01-25 20:51:44United StatesSt. Jude MedicalMassachusetts12293MAWestford, MA26111041http://jobs.sjm.com/xml/26111041/jobUSASylmarTechnician, Metrology Job Requisition #: 12272 Date Posted: 01/25/2012 Category: Metrology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs operational checks, preventative maintenance checks and accuracy verifications of measurement and test equipment used in production, and research and development (R&D). Takes initiative to ensure work is done accurately and completely. Performs assignments and solves problems that may have a variety of solutions. Adapts work methods to different situations. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel. Requirements/Education: High School diploma or equivalent, and Precision Measurement Electronics Lab (PMEL) certification in the U.S. military or equivalent electronics training. Typically a minimum of four or more years of progressively more responsible related work experience in the calibration of test equipment. Demonstrated knowledge and understanding of all aspects of the job, including the ability to set up and operate standard Metrology instruments, including oscilloscopes, counters, function generators, power supplies, and related equipment. Established eye-hand coordination, the capability to work with small precision devices and frequently used hand tools, a comprehensive knowledge of the calibration and test equipment required, and the ability to work independently under minimal supervision. Incumbents are required to work cooperatively and productively with others. Incumbents must also be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment. Demonstrated ability to read, write and converse in technical terminology, and perform a range of mathematical calculations and measurements. Considerable interpersonal, communication, organizational skills are required. The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. The demonstrated ability to lift equipment weighing up to approximately seventy pounds in order to place them in storage racks or test stations. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: An Associate’s degree in Metrology, Electronic Engineering Technology, equivalent trade school/military training, or comparable related experience. Demonstrated technical ingenuity and creativity to support/assist with calibration work. |E-mail this position Submit Resume or C.V.2012-01-25 20:51:23United StatesSt. Jude MedicalCalifornia12272CASylmar, CA26111014http://jobs.sjm.com/xml/26111014/jobUSALos AngelesEngineer II, Hardware Design Job Requisition #: 12300 Date Posted: 01/24/2012 Category: Leads Development Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Engineer II, Hardware Design Summary Working under general supervision, designs hardware to support features that are included as part of new product definitions. Designs verification testing (DVT) protocols. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Qualifications Requirements/Education: Bachelor of Science degree in mechanical engineering, a related field, or equivalent. Typically a minimum of three plus years of relevant hardware design, development, or testing experience including a general familiarity of manufacturing equipment/processes that is compatible with highly reliable electronic medical or similar devices. Ability to implement new design features as part of existing systems. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Ability to deliver research information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Six-Sigma knowledge and experience. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. Engineer II, Hardware Design Summary Working under general supervision, designs hardware to support features that are included as part of new product definitions. Designs verification testing (DVT) protocols. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Qualifications Requirements/Education: Bachelor of Science degree in electrical/mechanical/biomedical engineering, a related field, or equivalent. Typically a minimum of three plus years of relevant hardware design, development, or testing experience including a general familiarity of manufacturing equipment/processes that is compatible with highly reliable electronic medical or similar devices. Ability to implement new design features as part of existing systems. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Ability to deliver research information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Six-Sigma knowledge and experience. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2012-01-24 20:55:06United StatesSt. Jude MedicalCalifornia12300CALos Angeles, CA26086255http://jobs.sjm.com/xml/26086255/jobUSASylmarEngineer I, Green Belt Continuous Improvement Job Requisition #: 12276 Date Posted: 01/24/2012 Category: Continuous Improvement Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Our Continuous Improvement group has a unique opportunity for a talented and skilled CI Green Belt who will be responsible for our Orange Belt and Green Belt certification programs. This is an excellent opportunity to join a well established program where CI is supported within the culture of the company. This opportunity will allow you to work for a medical device company where your contributions will significantly impact the quality of life of others. Position Duties: Working under Close supervision, have responsibility for our internal Orange Belt and Green Belt certification programs. Within the first six months on the job, the new hire will take ownership of all facets of our Orange Belt program. This includes teaching workshops in Lean and Mistake Proofing, mentoring candidates to implement improvements and create supporting documentation, coordinating and hosting monthly certificate boards and quarterly certification ceremonies, performing needed administrative tasks such as processing award checks and marketing the program internally for greater use. Additionally, within the first 6 months on the job, the new hire will co-sponsor the Green Belt program. This will include providing lectures on all Six Sigma subjects, mentoring candidates and coordinating Gate Reviews. As the new hire adjusts to the role, long term it is expected the person will begin developing new training material for the Orange Belt and Green Belt programs to eventually take full ownership of both programs. This person will also be expected to gain a strong understanding of St. Jude Medical as a company to maximize the benefit they bring to the organization through the application of CI tools and concepts. Requirements: Bachelors Degree in Engineering, or related field. Formal Green Belt certification from ASQ or a leading provider such as Air Academy, George Group, SigmaPro. Minimum three years or equivalent of experience providing training, mentoring candidates, & leading projects. Preferred work history in technical field such as aerospace, medicine, nuclear, or electronics |E-mail this position Submit Resume or C.V.2012-01-24 20:54:03United StatesSt. Jude MedicalCalifornia12276CASylmar, CA26086134http://jobs.sjm.com/xml/26086134/jobUSALos AngelesField Clinical Engineer, AF Job Requisition #: USD 9395 Date Posted: 01/04/2012 Category: Field Engineer Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Under the general supervision of the Field Service Manager is responsible for demonstration, set-up, testing, installation and service of Company products which include devices and equipment for diagnosis, monitoring, managing and treating arrhythmias. Essential Functions: Provide Support for sales and marketing personnel in the set up and demonstration of Company products including the development and presentation of sales proposals. Provide technical support to customers and prospective customers by responding to inquiries and providing effective and timely resources and /or personal competencies. Provide educational and training support to customers and prospective customers including on-site clinical training for physicians and other medical personnel. Respond to emergency situations involving the use of Company products. Provide on-call or on-site resources to solve equipment and /or usage issues. Provide required support to Field Service personnel in the routine service of Company products. Develop and maintain effective professional relationships with physicians and EP Lab personnel. Represent the Company as a professional and competent resource in support of client and Company objectives. Qualified candidates will have two years of related experience including familiarity with cardiac electrophysiology equipment in EP lab environment including installation and repair of related hardware/software. A good understanding of MS-DOS, MS-Windows and PCs as well as good verbal and written communication skills. A willingness to travel approximately 80% of the time. A college degree in related disciplines is preferred. Ability to travel for long periods (up to 6 hrs) either by airplane or automobile. Ability to stand for long periods in clinical cases (up to 6 hours). Move and manipulate large, heavy objects during installation/demo and service activity (up to 60lbs.) |E-mail this position Submit Resume or C.V.2012-01-04 18:48:24United StatesSt. Jude MedicalCaliforniaUSD 9395CALos Angeles, CA25690399http://jobs.sjm.com/xml/25690399/jobUSAOklahoma CityTerritory Manager, Structural Heart Job Requisition #: USD 9385 Date Posted: 01/02/2012 Category: Sales Location: Oklahoma City - OK - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Calls on physicians, medical laboratories, distributors, and hospitals to sell a variety of St. Jude Medical/Structural Heart products and medical devices in an assigned territory. May conduct marketing surveys, effectiveness reviews of calls/sales activities, and territory analysis. Services accounts, suggests and presents new products, and takes product orders. As appropriate, assists marketing personnel on advertising and promotional sales strategies. Requirements/Education: Bachelors degree in a relevant technical field or equivalent and typically four plus years of progressively more responsible sales experience, including experience with medical devices. Working knowledge of domestic regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; and familiarity with medical device industry policies, operations and procedures. Documented record of delivering sales/marketing information which adds value to managements decision making process. Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives. Demonstrated verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated working knowledge of frequently used personal computer programs and relevant applications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiac sealing device technology. |E-mail this position Submit Resume or C.V.2012-01-02 18:51:07United StatesSt. Jude MedicalOklahomaUSD 9385OKOklahoma City, OK25657635http://jobs.sjm.com/xml/25657635/jobUSAGrand RapidsDir, Regional Sales, CRM Job Requisition #: USD 9375 Date Posted: 12/20/2011 Category: Sales Management Location: Grand Rapids - MI - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has primary management responsibility directly or through subordinates for directing the CRM sales of SJM/USD products and/or services in a specified region or other major geographical area. Exercises direct supervision over Company sales representatives, and acts in a liaison capacity with independent sales rep firms. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems; ensures employee compliance with such policies, practices and procedures. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. May be responsible for processes across Regional or organizational lines. Requirements/Education: A Bachelors degree in Business Administration, Marketing or equivalent. Typically eight plus years of progressively more responsible work experience in Tachycardia/Bradycardia product areas or a related discipline, including direct experience in CRM product sales. Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position. Must be skilled at delegation, follow-up, and team building. Has direct knowledge about physicians in the CRM medical market. Seasoned judgment acquired through organizational experience and achievements applying state-of-the-art sales principles. Documented record of delivering sales information which adds value to managements decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills. Must be able to perform intermediate level arithmetic calculations, including ratios, rates and percentages; draw and interpret graphs; apply the principles of rational systems to solve practical problems; effectively deal with a variety of tangible variables in situations where only limited standardization exists; and interpret a variety of instructions furnished in written, diagrammatic or schedule form. Must have a comprehensive working knowledge of frequently used personal computer programs and applications, such as, e-mail, Microsoft Office, graphics software, etc.. Desired Requirements: An advanced credential in a relevant discipline or concentration. Professional certification or designation. A comprehensive understanding of cardiac rhythm management (CRM) technology. |E-mail this position Submit Resume or C.V.2011-12-20 22:13:22United StatesSt. Jude MedicalMichiganUSD 9375MIGrand Rapids, MI25483081http://jobs.sjm.com/xml/25483081/jobUSASunnyvaleQuality Technician Job Requisition #: 12039 Date Posted: 12/14/2011 Category: Technician Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under general supervision, provides quality inspection and support services as required by Company quality provisions. Takes initiative to ensure work is done accurately and completely. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel within the Quality organization. Requirements/Education: High School diploma or equivalent. A minimum of four or more years related experience in quality/inspection activities. Demonstrated knowledge and understanding of all aspects of the job, including common inspection methods. Demonstrated ability to use frequently used hand tools. Demonstrated verbal and written communication, interpersonal, organizational and basic math skills. Demonstrated ability to read and understand engineering drawings. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: 1-2 years of experince. An Associates degree in Electrical/Mechanical Technology, equivalent trade school/military training, or comparable related experience in biomedical field. Prior experience working in an air-conditioned clean-room manufacturing environment. |E-mail this position Submit Resume or C.V.2011-12-14 23:10:48United StatesSt. Jude MedicalCalifornia12039CASunnyvale, CA25361322http://jobs.sjm.com/xml/25361322/jobUSASunnyvaleSr. Software Development Engineer Job Requisition #: AF13676 Date Posted: 12/12/2011 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Senior Software Engineer to meet our standard product development needs as well as increase our ability to deliver integrated hardware and software solutions to meet our project specific requirements. Impact this role will have within the AF division: • The Senior R&D Software Engineer designs and develops application software for RF ablation systems. • This role writes product requirement documents, designs, develops code, unit tests and helps out the verification team. Required Qualifications: • Bachelor’s degree in Computer Science, Computer or Electrical Engineering • 7 + years hands-on development experience with real-time embedded hardware, software design and development, and programming experience in C/C++, QT, Object Oriented programming with knowledge of Hardware interfaces and microprocessors • Experience with Linux, or other real time operation system, OS kernel module, device driver development • Familiarity with software configuration and software defect tracking systems • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks • Effective verbal and written communication skills to interact with associates at all levels of the organization, vendors and other SJM entities • Adaptability to frequent change in the work environment • Ability to prioritize responsibilities and ensure deadlines are met • Proficient working knowledge of MS Word, Outlook, PowerPoint, Excel and Project • Experience with 3D image processing, registration and rendering software design, Wireless protocols • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Masters degree in Computer Science, Computer or Electrical Engineering • Experience with RTOS, debugging tools and good software development processes • Working knowledge of entire software development and test cycle with at least one complete FDA regulated medical device product development cycle. Knowledge of applicable international regulations and standards (QSR, ISO 13485, ISO14971) • Formal training in Program/Project Management or Program Management Professional Certification |E-mail this position Submit Resume or C.V.2011-12-12 21:45:19United StatesSt. Jude MedicalCaliforniaAF13676CASunnyvale, CA25308317http://jobs.sjm.com/xml/25308317/jobUSASylmarProgrammer Analyst II Job Requisition #: 12016 Date Posted: 12/08/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Programmer Analyst II Summary Working under general direction, maintains business application systems. Performs all phases of systems and programming development and maintenance by preparing detailed specification from which programs will be written in support of the assigned project(s) or group(s). Performs systems analysis, programming, problem resolution and internal consulting for new and existing technical systems applications, including vendor packages. Analyzes and revises system logic, coding and documentation as necessary. Qualifications Requirements/Education: Bachelors degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of three plus years of progressively more responsible systems analysis, design, programming and testing experience. Broad knowledge of RPG/400, JAVA, C++ and /or Visual Basic; experience with software engineering concepts. Demonstrated experience working on a large projects in a team environment. An understanding of system architecture principles as well as a variety of databases, procedural languages and data communications is required. Ability to translate client requirements into a feasible design solution. Demonstrated ability to use proper coding techniques and efficiencies, testing methodologies, with an understanding of the operating system. Planning, organizational, interpersonal and communication skills. Demonstrated verbal and written analytical/problem solving, communication, interpersonal and presentation skills required sufficient to conduct discussions, interviews, negotiations, and give presentations. Must be able to handle multiple projects simultaneously. Demonstrated personal computer skills including spreadsheet, word processing and data base management. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. Specific Job Skills Specific and Preferred: Experience and knowledge of manufacturing processes, SAP, SAP middleware, and labeling systems preferred. Must be a team player with excellent oral and written communication skills and able to travel up to 20%. |E-mail this position Submit Resume or C.V.2011-12-08 18:56:02United StatesSt. Jude MedicalCalifornia12016CASylmar, CA25251483http://jobs.sjm.com/xml/25251483/jobUSAWestfordAccountant I Job Requisition #: 11964 Date Posted: 11/28/2011 Category: Accounting Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview PRIMARY DUTIES AND RESPONSIBILITIES: • Responsible for fixed asset general accounting including reconciliation of accounts. • Assists with overall analysis, reconciliation and review of other complex, key accounts. • Reconcile selected accounts to the general ledger in order to reflect accurate accounting in accordance with GAAP -Recommend appropriate correcting entries and improvements in accordance with GAAP. -Prepare monthly journal entries and work papers which require an understanding of complex accounting rules and principles. -Assists in executing the general ledger close process, implementing system enhancements and driving continuous improvements where possible. • Ensures accuracy and quality of general ledger close process and implements improvements to the close cycle whenever possible. • Assist in the facilitation of annual budgeting, quarterly forecasting, and annual strategic planning process. • Internal liaison and consultant for specific departments’ monthly analysis, budgeting, quarterly forecasting, and annual strategic planning processes. • Partner with upper management and functional management to fulfill reporting and analysis requirements. • Supports internal and external audits as required by preparing related work papers and analysis • Assists with monthly balance sheet analysis. • Special project analysis and backup support involving financial data. QUALIFICATIONS: • Bachelor’s degree in Business Administration, Accounting, Finance or equivalent experience required • 1-3+ years of previous general accounting experience or similar preferred • Strong Microsoft Office capabilities required • Ability to manage multiple tasks and priorities and work independently • SAP experience preferred • Ability to query and refine data into summarized results • Strong analytic skills and demonstrated capacity for accuracy • Ability to interact with people at all levels of the organization in a professional manner • Ability to maintain confidentiality of sensitive information • Ability to analyze processes and procedures and recommend improvements • Medical device manufacturing experience a plus |E-mail this position Submit Resume or C.V.2011-12-06 21:12:23United StatesSt. Jude MedicalMassachusetts11964MAWestford, MA25214114http://jobs.sjm.com/xml/25214114/jobUSASunnyvaleBiostatistician Job Requisition #: 11977 Date Posted: 11/30/2011 Category: Clinical Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Accountable to provide statistical input into the design of clinical studies, investigational plans, case report forms, database setup, edit checks, and clinical reports. Also responsible for providing consulting services to departments other than Clinical Affairs. Monitors own work performance and reports status to management. Coordinates technical decisions across organizational lines. Remains abreast of and consults on biostatistical and related advancements. Assures that quality of services meets or exceeds internal customer requirements. Requirements/Education: Masters of Science degree Biostatistics with 3 years experience of PhD in Biostatistics with 1-2 years experience. Prefer exposure to medical device industry. Requirements include an expert knowledge and experience of: computer science; biostatistical theory and application; and effective methods of working with clinical teams. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering biostatistical information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized statistical software packages with an emphasis on strong skills using Statistical Analysis System (i.e., SAS) software. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. |E-mail this position Submit Resume or C.V.2011-11-30 23:14:47United StatesSt. Jude MedicalCalifornia11977CASunnyvale, CA25120522http://jobs.sjm.com/xml/25120522/jobUSASylmarInformation Security Architect, Specialist Job Requisition #: 11965 Date Posted: 11/29/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Info Security Architect, Spec Summary Working independently with rare managerial oversight and direction, is accountable for the security design of the Divisions information systems and for ensuring that the information technology (IT) systems are protected from any and all threats. Executives on a range of security-related issues including establishing information system boundaries, assessing the severity of weaknesses and deficiencies in information systems, plans of action and milestones, risk mitigation approaches, security alerts, and potential adverse effects of vulnerabilities. Identifies and routinely uses most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness. Work requires the application of business principles/methods, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year academic course of study. Exercises significant independent judgment in the planning, organizing and performing of work assignments; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise. May participate on or lead work teams; may provide work direction or guidance to a group of employees. Qualifications Requirements/Education: A Bachelors Degree in Computer Science, Engineering, or a related technical academic field. A minimum of six plus years of progressively more responsible Information Systems experience. Evaluation, originality and/or ingenuity required. Expert proficiency in all aspects of information security, (e.g. system design, vulnerability management, risk analysis, forensics). Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering IT security information that adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA), information security and privacy regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Applicable certifications (e.g. Certified Information Systems Security Professional (CISSP), Certified Ethical Hacker (CEH)) Specific Job Skills CISSP, Certified Ethical Hacker, InfoSec assessments |E-mail this position Submit Resume or C.V.2011-11-29 19:40:33United StatesSt. Jude MedicalCalifornia11965CASylmar, CA25090377http://jobs.sjm.com/xml/25090377/jobUSAIrvineManufacturing Manager II Job Requisition #: AF13629 Date Posted: 11/23/2011 Category: Manufacturing Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, talented and results-oriented Manufacturing Manager II to join our Irvine, California facility. The successful candidate will manage and lead the production and distribution activities for a three shift manufacturing facility. Impact this role will have within the AF division: • Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development. • Accountable for the development of staff: critiques, instructs, mentors, evaluates and coaches to maintain current industry standards for field of responsibility and that safety requirements for laboratories and chemical handling are met within department. • Maintains a strong customer focus. • Models optimum leadership competencies to inspire an energized, empowered and accountable work force. • Develops/monitors/controls budgets for multiple assigned areas and meets area financial objectives. • Cooperatively develops annual operational build and financial plans and over achievement/continuous improvement plans. • Determines resources to meet project objectives and manage budgets. • Forecasts and reports resource consumption area activity, performance and financial trends. Monitor/reduce inventory levels. • Develops production plans and initiates activity to meet production demand requirements and business needs. • Leads capital improvement projects and prepares capital expenditure requirements. • Conducts feasibility studies and develops project schedules. • Provide vision, strategies and tactics to ensure sustainable competitive advantage of assigned areas. • Maintains regular, reliable, and predictable attendance. • Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other essential functions and responsibilities as determined by the company from time to time. Required Qualifications: • Bachelors Degree in Business, Engineering or Sciences. • 7+ years of leadership experience in a high-volume, multi-product manufacturing environment. • Ability to learn, train, and follow good manufacturing practices (FDA/GMP's) and other applicable regulatory standards (i.e., ISO9000) and ensures operational compliance. • Solid people management skills, including demonstrated ability to coach, mentor and develop employees. • Solid communication, interpersonal, and motivational skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience leading and implementing lean manufacturing/Six Sigma and change initiatives. • Medical device industry experience. • Masters Degree in Business, Engineering or Sciences. • SAP. To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2011-11-23 16:26:07United StatesSt. Jude MedicalCaliforniaAF13629CAIrvine, CA25029408http://jobs.sjm.com/xml/25029408/jobUSAMaple GroveIntern - Business Development Job Requisition #: 11921 Date Posted: 11/14/2011 Category: Internship Location: Maple Grove - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Cardiovascular Division: Job Overview Summary: Work closely with SJM business groups and cross-functional leadership to execute strategies that drive opportunities in SJM’s businesses. •Key responsibilities include financial analysis, market research and other support on a variety of business development projects including acquisitions, equity investments, strategic alliances, joint ventures, technology licenses, financings, analyst presentations and strategic planning. Essential Functions: •Provide financial analysis and competitor/market research support to functional and business group units. •Assist cross-functional teams throughout the lifecycle of business development projects (including support roles with projects related to transaction screening/monitoring, financial analysis, due diligence, negotiation, integration and strategic planning). •Perform and present analyses of companies, projects and markets of potential strategic interest. Provide financial, competitor and market analyses for strategic planning processes. •Provide analytical support to legal and finance, including developing and analyzing transaction/project structures and developing analyses for transaction-related legal documents. •Serve as a focal point with third parties, including SJM business/functional units, entrepreneurs, venture capitalists and investment bankers. •Develop broad knowledge of SJM’s business units and technologies. Develop good working relationships with key opinion leaders across SJM and in the medical technology industry Education and/or Experience: •Four year degree in finance or marketing degree preferred. •Enrollment in accredited MBA program required. Prefer 1st year MBA student. •Must be a current student enrolled in the 2012 Spring and Fall Semesters. •A minimum of two years of investment banking, private equity or business development experience required. •Must have excellent interpersonal skills and strong strategic management skills. •Experience in medical device industry preferred. •Must have a high degree of initiative, motivation and passion for the business. •Must have strong analytical and prioritization skills with the ability to manage several projects simultaneously. •Must be able to perform under pressure and in a very dynamic environment. •Must be able to work, direct, and take direction with all levels of management. •Must be able to perform in a diverse cross-functional team environment. •Must have ability to understand complex concepts including disease states/physiology and technical/product information. •Advanced personal computer skills, including experience with Microsoft Office is required. Assignment: June-December 2012, with possibility of continuing Spring Semester of 2013 Please note: There is no housing or relocation available. |E-mail this position Submit Resume or C.V.2011-11-14 19:22:38United StatesSt. Jude MedicalMinnesota11921MNMaple Grove, MN24853532http://jobs.sjm.com/xml/24853532/jobUSASunnyvaleBiostatistician Job Requisition #: 11855 Date Posted: 11/08/2011 Category: Clinical Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Accountable to provide statistical input into the design of clinical studies, investigational plans, case report forms, database setup, edit checks, and clinical reports. Also responsible for providing consulting services to departments other than Clinical Affairs. Monitors own work performance and reports status to management. Coordinates technical decisions across organizational lines. Remains abreast of and consults on biostatistical and related advancements. Assures that quality of services meets or exceeds internal customer requirements. Requirements/Education: Masters of Science degree Biostatistics with 3 years experience of PhD in Biostatistics with 1-2 years experience. Prefer exposure to medical device industry. Requirements include an expert knowledge and experience of: computer science; biostatistical theory and application; and effective methods of working with clinical teams. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering biostatistical information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized statistical software packages with an emphasis on strong skills using Statistical Analysis System (i.e., SAS) software. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. |E-mail this position Submit Resume or C.V.2011-11-08 20:41:09United StatesSt. Jude MedicalCalifornia11855CASunnyvale, CA24757508http://jobs.sjm.com/xml/24757508/jobUSASt. PaulSoftware Engineer II Job Requisition #: AF13645 Date Posted: 11/04/2011 Category: Software Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Software Engineer to develop and maintain complex features involving algorithms for the EnSite Velocity and EP-WorkMate systems and related systems. The ideal candidate will have proven experience in both algorithm development and software product development. This position will partner and work with applied research engineers to develop and transition algorithms into software products. Impact this role will have: • Develop and support software for the EnSite Velocity product. This engineer will work closely with the Applied Research team and with other software developers to transition, develop and support advanced algorithms to a commercial product. • Support the development of EnSite Velocity and EP-WorkMate software features related to 3D geometric models of the heart chambers, location tracking, filtering and other advanced algorithms. Duties will include working within an engineering process to specify, design, and develop features. This software engineer will be working with the Applied Research group to support transitioning research into product. • Author and maintain software design documentation. Required Qualifications: • BS or MS in Computer Science or other Engineering or Math discipline; minimum 2 years in a software development field. • Experience with one of the following: computational geometry algorithms, digital filtering algorithms or image processing. • Expertise in C++. Experience working in Linux/UNIX. • Experience with multithreading, OpenMP, Qt or a similar framework. Preferred Qualifications: • Experience with CUDA and OpenGL graphics is desired. • Experience with Windows development and MS Visual Studio. |E-mail this position Submit Resume or C.V.2011-11-04 18:04:56United StatesSt. Jude MedicalMinnesotaAF13645MNSt. Paul, MN24688426http://jobs.sjm.com/xml/24688426/jobUSAAustinStructural Heart Product Marketing Manager Job Requisition #: USD 9307 Date Posted: 10/24/2011 Category: Marketing Location: Austin - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Has primary management responsibility for developing and implementing systems, services and programs that will produce maximum results from targeted sales and marketing processes. Has a primary responsibility to ensure that specific marketing initiatives within Structural Heart Product Division are aligned, implemented, and recorded as sales initiatives across all functional aspects within USD, with a specific emphasis on Amplatzer Structural Heart Occlusion Systems. Has collateral responsibility to identify opportunities to build sales in under-serviced markets, both current and future. Has responsibility to drive and execute customer educational programs. Has responsibility for support to Product Division Marketing regarding product design, product development and ongoing product engineering. Has responsibility for the design and implementation of product-defined sales and metrics with respective application to USD management. Sets goals, ensures that they are met and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements. Exercises judgment in planning and organizing work; monitors performance and reports status. Uses best business practices to ensure success in areas of responsibility. Requirements/Education: A Bachelors degree in Business Administration, Marketing or equivalent plus 3-5 years of progressively more responsible business experience in a medical device company including product or market management experience. Seasoned judgment acquired through organizational experience and a demonstrated record of achievements in successfully building a business. A substantive knowledge of interventional cardiology or cardiac surgery health care delivery, and managed care/reimbursement markets and the factors that drive them is required. A thorough understanding of product and market management, physician, and patient marketing is also required. Demonstrated ability to effectively prioritize development projects using customer input. Requires the ability to track financial metrics and make appropriate adjustments to successfully achieve revenue/unit goals. Documented record of delivering marketing information which adds value to managements decision making process. Demonstrated verbal and written communication, interpersonal and presentation skills; the ability to lead a cross-functional team. Demonstrated working knowledge of frequently used personal computer programs and applications, such as, Microsoft Office. Must be adept at handling multiple assignments and accomplish these projects within budgetary guidelines. Desired Requirements: Medical Device product marketing experience. Product launch experience with successful track record of sales achievement. Physician training and education experience. |E-mail this position Submit Resume or C.V.2011-10-24 18:54:06United StatesSt. Jude MedicalTexasUSD 9307TXAustin, TX24382365http://jobs.sjm.com/xml/24382365/jobUSAChicagoField Service Technician Job Requisition #: USD 9292 Date Posted: 10/17/2011 Category: Technician Location: Chicago - IL - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Working in the field, under the supervision of the Manager of Technical Services, the primary responsibility of the Field Service Technician (FST) is to ensure that St. Jude Medical equipment performs properly and safely by performing installs, service calls for repairs, hardware and software upgrades, as well as preventative maintenance in order to meet the equipment standards set fourth by AFD. In conjunction with this primary responsibility, the FST must document their work and prepare accurate reports in the highly regulated medical device industry. The FST will perform the primary responsibilities within an assigned FST region. The FST will need to attend training on specific equipment annually. Requirements/Education: Demonstrated ability to perform the essential function of the job by either: 1) a minimum of 4 years of field technical experience, preferably in servicing equipment in the healthcare or other regulated environment; or 2) 2-year degree in a relevant field (such as science, electrical engineering, or mechanical engineering) and a minimum of 2 years of field technical experience, preferably in servicing equipment in the healthcare or other regulated environment. Valid drivers license. Able to travel 70-100% of the time. Able to meet vendor access policy qualifications for hospitals. Desired Requirements: Demonstrates knowledge of technical and repair skills in the field. Possess excellent written, oral and presentation skills, including demonstrated ability to prepare written documentation in regulated environment. Demonstrates strong organizational skills, ability to prioritize tasks and manage time efficiently. Able to work collaboratively and professionally with management, peers, and customers as an AFD employee. Proficient in computer operations, including Microsoft Word, Outlook, and Excel. |E-mail this position Submit Resume or C.V.2011-10-17 21:41:59United StatesSt. Jude MedicalIllinoisUSD 9292ILChicago, IL24266555http://jobs.sjm.com/xml/24266555/jobUSALos AngelesEngineer II, Clinical-Systems Job Requisition #: 11808 Date Posted: 10/13/2011 Category: Clinical-Systems Engineering Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Engineer II, Clinical-Systems Summary Working under general supervision, supports product development efforts by performing clinical-systems engineering tasks such as investigating, defining, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Responsible for gaining a firm understanding of clinical applications, customer needs to be addressed, behaviors, and architected solution of the assigned portion of the system. Performs additional analysis and/or interviews to determine requirements and constraints on the assigned portion of the system and to resolve cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Demonstrates aspects of technical or organizational leadership within the current projects. Has ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating clinical-systems engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelors Degree in Biomedical Engineering, a related field, or equivalent including relevant coursework and/or work experience in product development (especially definition and validation), cardiology and electrocardiogram interpretation. Typically a minimum of two plus years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is also required. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Documented record of delivering clinical-systems engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Desired Requirements: An advanced credential in a relevant discipline/concentration; a Biomedical Engineering degree is preferred. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Six-Sigma, and various technical applications as noted above. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2011-10-14 20:11:44United StatesSt. Jude MedicalCalifornia11808CALos Angeles, CA24231647http://jobs.sjm.com/xml/24231647/jobUSALos AngelesManager, Product Marketing Job Requisition #: 11816 Date Posted: 10/13/2011 Category: Marketing Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mgr, Product Marketing Summary Working under limited supervision, has primary management responsibility for developing comprehensive and integrated portfolio and commercial strategies within core CRM markets and product segments. Responsible for early phase product planning activities including business justification, executing and managing implementation of commercial strategies and development and execution of product commercialization plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Qualifications Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible experience in a Marketing capacity, with focus on strategic product planning and commercial execution. Requires developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential; Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2011-10-14 20:11:21United StatesSt. Jude MedicalCalifornia11816CALos Angeles, CA24231634http://jobs.sjm.com/xml/24231634/jobUSASt. PaulSenior Research Engineer Job Requisition #: AF13616 Date Posted: 09/30/2011 Category: Research Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division in Italy. Job Overview We are seeking an experienced, self-motivated individual to define development of new technologies for Physicians at clinical laboratories of excellence. This role will drive Research and Development programs, support research collaboration, and clinical activity involving St. Jude Medical products used in the electrophysiology laboratory. This role will lead collaborative discussions between Physician customers and St. Jude Medical technical teams to define and provide new technologies. Impact this role will have within the AF division: ? Support research and clinical activity involving St. Jude Medical technology at the center of excellence. ? Drive development programs for existing technologies while being the key interface between the clinical laboratory of excellence and St. Jude Medical teams. ? Lead research programs to define and develop novel technologies by collaborating with Physicians and St. Jude Medical teams. ? Monitor and report progress, assessing existing technology and defining requirements for new technology. Required Qualifications: ? A BS degree with at least 5 years experience or a MS degree with at least 3 years experience, in Electrical Engineering, Physics, Mathematics or Biomedical Engineering. ? Flexibility to travel from the USA to Europe on short notice, with trips away of multiple weeks. ? Research and development experience with technology used in the field of electrophysiology. ? Software skills to perform data analysis of clinical and preclinical data. ? Above average experience working with Physicians and cross-functional development teams. ? Possess strong documentation and verbal technical communication skills. Preferred Qualifications: ? Experience with Matlab, C, C++, Statistical Analysis software. To learn more, visit our web site at www.sjm.com St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2011-09-30 22:01:15United StatesSt. Jude MedicalMinnesotaAF13616MNSt. Paul, MN23953890http://jobs.sjm.com/xml/23953890/jobUSASt. PaulEngineer-Electrical Engineer Job Requisition #: 11710 Date Posted: 09/30/2011 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Cardiovascular Division: Job Overview Duties and Responsibilities: The successful candidate will serve as a Subject Matter Expert (SME) in the R&D Science & Technology Group to participate in various stages of product development as well as cross-functional activities. The position will be responsible for providing technical expertise, consultation and project support. Position will be responsible for selection and characterization of materials acceptable for use in medical device and design. Position will provide guidance in establishing material device specification, supporting existing product development products and proactively providing technical solutions for design issues related to material failures. Position will assist in designing and conducting performance evaluation activities of medical implants and materials. Provide product design advice based on conclusions of testing and research activities. Individual will be responsible for providing guidance in electrical engineering and provide technical lead support on projects supporting devices that use RF energy to ablate soft tissue. Candidate must have strong ability to apply knowledge of RF ablation of soft tissue and electrical engineering techniques to provide imaginative solutions to a wide range of difficult problems. Individual should have a fundamental understanding of biomedical materials, chemical processes, biological systems, and surface/analytical methodology. Analyze, interpret and draw conclusions from technical evaluation. Remain current with technology and testing standards. Qualifications: Expertise in electrical engineering with focus on RF energy ablation of soft tissue is required. Individual must communicate well with all levels of management and employees. Candidate must work well in collaborative environment across functional areas. Candidate must have: •Strong background in RF ablation. •Strong experience in working with active implants, RF electro-thermal system; strong capability of setting up comprehensive study and assessing in vitro and in vivo properties of device/device components. •Knowledge of the electrode/tissue interface of electrical based systems for cardiovascular therapy. Ability to design and develop experimental test setups to evaluate new concepts in cardiovascular therapy. Willingness to perform hands on lab work. Concise, organized, can multitask with the ability to prioritize. Proficient with computers. Excellent written and verbal communication skills. Previous experience with R&D product development teams in medical device industry desired. PhD with 2 years MS with 3-6 years BS with 5-8 years of relevant product development expertise |E-mail this position Submit Resume or C.V.2011-09-30 22:01:12United StatesSt. Jude MedicalMinnesota11710MNSt. Paul, MN23953886http://jobs.sjm.com/xml/23953886/jobUSASylmarSystems Analyst, Senior Job Requisition #: 11536 Date Posted: 08/25/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Senior Systems Analyst – Information Security Here’s an excellent and exciting opportunity to join a progressive IT group with the responsibility of information security. This is not an operations role but an opportunity that will allow you to do security design work, focusing on architect solutions from the start or design solutions for existing systems. Your primary focus as it relates to information security will be on remote care and protection of health care information. You are responsible for protecting, by design, our complex IT systems against information security vulnerabilities and threats. If you have substantial experience doing information security engineering work and have architected security systems, we want to hear from you. Within this role, if hired, your initial focus will primarily be on information security design work on remote care/health care information. You will be expected to deliver technical Information requirements and review detailed designs from all layers of IT technology such as database, operating system, networking, middleware, etc. You will work with the InfoSec compliance team to map regulatory requirements to IT architecture. Longer term, when these systems are subject to compliance audits the systems that you participated in designing will be found to be sound and compliant with our InfoSec policies and regulatory requirements in information Confidentiality, Integrity and Availability. If hired, you will interact with non-IT personnel as much as with IT personnel, such as SW development, System Engineering, Legal, Product Development, etc. Will work with a small but very dedicated team in IT Information Security that takes their stewardship of our information assets very seriously. Will often work largely independently with no micro-management. Within this role, it is expected you to be a Certified Information Systems Security Professional (CISSP); hands-on experience securing IT infrastructure and/or code; experience in designing and documenting designs of security controls for IT Systems; excellent presentation and communication skills. Must have 5+ years experience with a focus on information security. Desired skills include being a Certified Ethical Hacker (CEH); ISO 27001/27002; software development experience; Information forensics; InfoSec incident management; biotech industry experience. Experience with health care information is a big plus. |E-mail this position Submit Resume or C.V.2011-09-27 19:28:11United StatesSt. Jude MedicalCalifornia11536CASylmar, CA23871408http://jobs.sjm.com/xml/23871408/jobUSASt. PaulMarketing Manager II Job Requisition #: AF13612 Date Posted: 09/19/2011 Category: Marketing Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Product Marketing Manager that will be part of our AF Marketing Team. The successful candidate will be responsible for planning and execution of new product marketing strategies, product launches, product management, continuation marketing and sales support for assigned product lines. Impact this role will have within the AF division: • Leads rigorous and disciplined new product launch planning and post-launch monitoring to ensure that new products meet AFD Op Plan goals for revenue growth. Includes working collaboratively with the U.S. and international selling divisions to establish strategies and tactics for product messaging and positioning, promotion, pricing, sales rep and customer education, limited market release programs, and organizational communication and alignment plans. • Leads on-going lifecycle management of existing products to ensure AFD can maximize revenue and gross margin opportunities associated with current generation devices. Includes driving continued customer/sales force product promotional and educational programs, providing on-going competitive product education to the field, and leading the technical teams in the identification and resolution of product performance and procedural issues to ensure the highest levels of customer satisfaction. • Conceives and executes broader programs (e.g., market development, patient education, clinical data development, KOL development, publication and podium presence, etc.) that create more preference for SJM products and services. • Partners with the U.S. and international selling divisions to provide support at SJM events such as conferences, symposia, sales meetings, sales training sessions, and regional events. Provides on-going and prompt support in response to customer or field rep inquires and requests. Is recognized as a go to” person with respect to both the business and technical sides of the product lines for which this individual is responsible. • Provides input to engineering to help guide the development of next generation products and services. Establishes disciplined methods of gathering customer feedback and determining product/service requirements. • Provides direction to manufacturing on inventory forecasts. Continuously monitors inventory situation by periodic review of US and OUS sales reports as well as through on-going dialogue with the selling divisions and manufacturing team. Required Qualifications: • BS or BA degree in business, physical/life science, nursing, or engineering. • 5+ years of marketing experience in medical devices. • Self-directed – identifies what needs to be done and executes appropriately with little supervision. • Pro-active – anticipates problems and acts appropriately. • Excellent written and oral communication skills. • Ability to multi-task in order to meet deadlines. • Ability to influence cross-functionally and cross-divisionally without authority. • Resilient – finds ways to get things done when initial or usual approaches do not work. • Intellectually curious – strong desire to learn and willing to invest the time both inside and outside of work to do so. • Team player. • Willing to travel as needed (up to 35%) with occasional weekend travel. • Creative, out of box” thinker who thrives on developing and executing marketing strategies and tactics. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • MBA strongly preferred • Medical device, biotechnology, or pharmaceutical sales experience a plus • Prior electrophysiology and/or cardiac rhythm management experience preferred • Prior product marketing experience preferred |E-mail this position Submit Resume or C.V.2011-09-19 19:38:36United StatesSt. Jude MedicalMinnesotaAF13612MNSt. Paul, MN23703439http://jobs.sjm.com/xml/23703439/jobUSANoneSr. Clinical Research Associate - Regional Job Requisition #: 11541 Date Posted: 08/24/2011 Category: Clinical Location: Central - Region - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Cardiovascular Division: Job Overview The Sr CRA Regional will conduct site initiation visits, monitor clinical data for multiple studies, and conduct close-out visits. Supports professionalism and scientific expertise of the department. Responsibilities: • Follows department Standard Operating Procedures. • Monitors clinical investigations for multiple studies and sites simultaneously, to a. Assure protocol compliance per applicable regulations; b. Assure subject rights, safety and welfare are protected; c. Assure data integrity through completeness, accuracy, legibility and logicalness. • Completes monitoring reports and follows open action items in a timely basis. • Assists Clinical Research Associate in setting up sites (Clinical Research Agreements, IRB Approvals, etc.) • Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations. • Assists in organizing Investigator and Data Safety Monitoring Board meetings. • Conducts monitoring visits to assure protocol compliance and data integrity. • Generates presentations when requested by investigators or AGA personnel. • Generates status reports and sends to investigators on a regular basis. • Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries. • Acquires professional, product and market expertise via independent reading, networking and training. • Travels approximately 85%. • Participates in professional activities outside of normal business hours. • Other duties as assigned. Education, Experience, Personal and Technical Skills: • BA/BS in business, medical science or nursing (or equivalent experience). • 5-8 years experience in Clinical Research, preferably in a medical device company. • 5 years monitoring experience, preferably in a field position. • Strong ability to prioritize and organize multiple projects, simultaneously. • Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization. • Excellent written and verbal communication skills. • Ability to work independently and take direction from others. |E-mail this position Submit Resume or C.V.2011-08-24 18:47:22United StatesSt. Jude MedicalNone11541NoneVirtual, USA23220963http://jobs.sjm.com/xml/23220963/jobUSAScottsdaleQuality Technician Sr. Job Requisition #: 11317 Date Posted: 08/02/2011 Category: Quality Location: Scottsdale - AZ - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Scottsdale, Arizona: Job Overview This is an exciting opportunity for a skilled quality technician who is interested in building life saving devices at our Scottsdale location. Working within a small team, within the first 6 months on the role, the Senior QA technician will come up to quick speed on the daily component and process issues that happen within the hybrid build process. Requirements/Education: High school diploma or equivalent, and trade school certification, specialized training/apprenticeship and/or equivalent in Electronics, Engineering Technology, or specialized training which provides a theoretical understanding of electronic or electro-mechanical disciplines or equivalent. Typically a minimum of eight or more years of progressively more responsible related quality/inspection experience required to achieve the level of competency and depth of understanding necessary to perform at this level. Considerable knowledge and understanding of all aspects of the job, including common inspection methods. Prior experience working in an air-conditioned clean-room manufacturing environment. General knowledge in electronics and in the operation of electronic measurement equipment (meters, oscilloscopes, frequency counters). Hands on experience with troubleshooting electro-mechanical circuits and a disciplined approach to troubleshooting. Desired solid knowledge of wire bonding, and soldering of surface mount components. |E-mail this position Submit Resume or C.V.2011-08-02 18:40:08United StatesSt. Jude MedicalArizona11317AZScottsdale, AZ22768251http://jobs.sjm.com/xml/22768251/jobUSASunnyvaleDirector, ATE Job Requisition #: 11370 Date Posted: 07/25/2011 Category: ATE Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Join the Cardiac Rhythm Management Division's Automated Test Engineering group. We are one of the world's leaders in the life-saving field implantable cardiac rhythm management devices, and we are looking to get even better by bringing on the world's best engineering talent! As a manager in the test engineering group, you will plan and manage all areas within test development. Your team will be involved in product development, design for testability, test hardware and software design, hands-on debug, characterization, manufacturing release and sustaining. You will manage 5 to 20 engineers and technicians, with analog, mixed-signal and digital technical focus. You may be involved in wafer level IC test development, test development for partial system assemblies, or device level test of the final product. You will be in charge of a key engineering function in the company's largest business division. Requirements: BSEE or MSEE 10+ years experience in analog or mixed-signal test development 5+ years managing test engineers "Hands-on". Technically savvy, especially with analog and mixed-signal circuits Excellent communication skills. Masterful at avoiding miscommunication, providing clear expectations. Focused and able to meet goals |E-mail this position Submit Resume or C.V.2011-07-25 18:20:57United StatesSt. Jude MedicalCalifornia11370CASunnyvale, CA22602291http://jobs.sjm.com/xml/22602291/jobUSAWestfordEngineer II, Test Job Requisition #: 11418 Date Posted: 07/19/2011 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Analog/Digital Engineer PRIMARY DUTIES AND RESPONSIBILITIES: Lightlab Imaging, a subsidy of St Jude Medical, seeks a talented electrical engineer to join a new product development group working on next generation imaging catheters. The successful candidate will work together with a Principal Analog Engineer as the electrical design team responsible for the performance and safety of various catheter mounted sensors. Responsibilities include designing the testing concepts based upon an understanding of the development goals and available technology, designing any necessary sensing circuitry, working with mechanical team to develop mechanical components, procurement and set-up of the overall equipment, qualification of early sensor prototypes using the equipment, and refinement of the test stations for production use. Additional responsibilities may include managing outside testing services where necessary. EXPERIENCE & SKILL REQUIREMENTS: Requirements BSEE with 5 years (MSEE with 2 years) Proficient with Network Analyzers and Oscilloscopes Strongly desired is experience in the following areas: Low Voltage 0-100Mhz Analog Circuit Design EMI suppression/shielding Medical Device Experience (especially Patient Isolation/Safety – IEC 60601) Product Performance Testing |E-mail this position Submit Resume or C.V.2011-07-19 18:40:07United StatesSt. Jude MedicalMassachusetts11418MAWestford, MA22480677http://jobs.sjm.com/xml/22480677/job