St Jude Medical Jobshttp://jobs.sjm.com2012-02-22 14:18:41USAMinnetonkaEngineer - Quality Job Requisition #: 12010 Date Posted: 11/29/2011 Category: Engineering Quality Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview 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 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 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: 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 methodologies (e.g., Six Sigma and Lean Manufacturing) ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-29 19:42:09MinnesotaMNMinnetonka, MN25090423http://jobs.sjm.com/xml/25090423/jobUSAMaple GroveSenior Packaging Engineering Manager Job Requisition #: 12013 Date Posted: 11/29/2011 Category: Engineering Location: Maple Grove - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Maple Grove. Job Overview Position Summary: Manages the planning and completion of packaging engineering projects, including the design and development of packaging and labeling processes, documentation, tooling, and fixtures in order to enhance productivity and product quality. Essential Functions: Provide leadership to packaging engineering staff regarding project prioritization, process validations, and continuous improvements Implement and manage resource planning and project management tools Support ongoing 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 packaging 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 Packaging Engineering or equivalent technical field; advanced degree preferred 10 years manufacturing experience, with 5 years of people management experience Solid knowledge of GMP, ISO regulations. Prior experience in medical device manufacturing 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.United StatesSt Jude Medical2011-11-29 19:42:15MinnesotaMNMaple Grove, MN25090430http://jobs.sjm.com/xml/25090430/jobUSASt. PaulProduct Manager- Deep Brain Stimulation Job Requisition #: ID11725 Date Posted: 11/11/2011 Category: Marketing Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview Provide Product Marketing support for Deep Brain Stimulant 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 products 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 years budget, current objectives and budget guidelines. MINIMUM QUALIFICATIONS Bachelors degree in business, sciences, or nursing required 2 + years sales and/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 playerability to work as a key member of the International Division marketing team. Strong leadership skillsability to function as the marketing lead on high profile projects around the world Project management skillsability 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 neuromodulation products preferred 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.United StatesSt Jude Medical2011-11-11 22:04:29MinnesotaMNSt. Paul, MN24833475http://jobs.sjm.com/xml/24833475/jobUSASt. PaulSr./ Manager, Marketing- NM Job Requisition #: ID11723 Date Posted: 11/11/2011 Category: Marketing Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview The Marketing Sr./Manager is responsible for managing a team of Product Managers to build the commercial roadmap for Neuromodulation products by working across all International Division geographies. The Marketing Manager will work with the Director of Neuromodulation Marketing to partner with our product division and geography colleagues to map and execute comprehensive plans supporting commercialization of Deep Brain Stimulation products. TYPICAL DUTIES AND RESPONSIBILITIES Manage Product Managers to build the commercial roadmap for assigned products. This includes: oDefining target markets which are appropriate to achieve revenue expectations oDetermining promotional pricing oCreating customer product information collateral oCreating customer training collateral oCreating sales training material oConducting sales product training Partner with global sales management to secure necessary sales representative attention for product lines Maintain global programs for products which have already been released including customer loyalty programs and appropriate multimedia campaigns Develop and maintain relationships with key opinion leaders Partner with geography marketing leaders to identify and drive a successful presence at key global tradeshows Manage key metrics to identify product penetration in global markets oDevelop and implement plans of action where penetration is weaker Manage performance of direct reports by coaching staff on regular basis, conducting performance evaluations in a timely manner, rewarding for excellent performance, addressing poor performance and managing employee development plans Manage the completion of quality and compliance requirements for team Plan and prepare product launches in cooperation with the Product Division/International Marketing and facilitate implementation throughout the geographies Work with the geographies to create post-launch programs to extend product launches. Help the geographies resolve product, regulatory and clinical issues that impact their ability to sell. Monitor and respond to changes in the market place based on performance vs. business and sales objectives by major geography. MINIMUM QUALIFICATIONS Bachelors degree in business, sciences, or nursing required 4 + years sales and/or marketing experience within Medical Device Industry including market plan development and experience managing multiple, simultaneous new product launches 5+ years experience using spreadsheets, databases and presentation software Strong communications and negotiation skills, 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 Excellent communication skillshas 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 product related decisions. Strong team playerability to work as a key member of the International Division marketing team. Strong leadership skillsability to function as the marketing lead on high profile projects around the world. Project management skillsability 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. PREFERRED QAULIFICATIONS MBA with Marketing emphasis preferred 5 years experience marketing Neuromodulation products 5 years experience managing team of Product Marketing Managers and/or Marketing Specialists TRAVEL REQUIREMENTS: 25-30% travel should be expected in Europe, Asia Pacific and Japan on regular basis with travel; up to 50% at times 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.United StatesSt Jude Medical2011-11-11 22:04:29MinnesotaMNSt. Paul, MN24833477http://jobs.sjm.com/xml/24833477/jobUSASt. PaulMarketing Communications Manager Job Requisition #: ID11729 Date Posted: 11/21/2011 Category: Marketing Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview The Marketing Communication Manager is responsible for the development and implementation of marketing communications programs to support St. Jude Medicals strategic objectives for the International Division. TYPICAL DUTIES AND RESPONSIBILITIES Partner with the Product Divsions and International Marketing Geography and Country teams to create collateral for customers, sales team, public affairs and other internal customers Manage and assure timely, efficient and professional distribution of marketing materials internally and externally Laise with a cross-functional team to ensure that content is reviewd by the appropriate resouces to ensure accuracy and on-targeting messaging Partner with Geographies and Country communications teams to execute marketing programs including email campaigns, intranet sites, webcasts, events and other campaigns Ensure consistent messaging and branding throughout campaigns, web content, trade show signage, and public relations activities Maintain up-to-date industry knowledge of trends, technologies, and best practices on an on going basis Manage performance of direct reports by coaching staff on regular basis, conducting performance evaluations in a timely manner, rewarding for excellent performance, addressing poor performance and managing employee development plans Oversee launch material inventory and coordinate kit assembly and distribution Manage reprints, print production and management of new materials as needed, inlcuding ordering of clinical article reprints Facilitate Congress strategy and planning with the Product divisions and Geography Marketing and Marcomm Team. Manages all requests to purchasing to ensure smooth transition of material into SAP Manage the marketing communications budget for assigned projects and program(s) Establish and maintain the ID Marcom library and update the ID Marcom portfolios quarterly Work closely with vendors regarding printing and fulfillment MINIMUM QUALIFICATIONS Bachelors degree in Business. Marketing Communications, Journalism, or Public Relations 5+ years experience in Marketing Communications in the medical device industry Previous experience working effectively in a complex, multi-tasking environment Strong individual self-starter who has ability to develop and execute on plans within time and within budget Strong influence management skillseffectively influences a wide variety geographies/cultures including Europe, Asia Pacific, Japan, Australia and Canada and functions Excellent verbal communication skillshas frequent contact with broad customer contact as well as interfaces with senior-level management from cross functional groups and geographies Strong team playerability to work as a key member of the International Division marketing team Excellent written communication skills to draft communications for far reaching international audiences Strong leadership skillsability to function as the marketing lead on high profile projects around the world Project management skillsability to manage complex projects and programs while pulling in the appropriate functional and geographic functions together to support initiatives Expertise is translating business goals and strategies into actionable and measurable marketing and communication campaigns TRAVEL REQUIREMENTS: 25-30% travel should be expected in 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.United StatesSt Jude Medical2011-11-21 20:07:01MinnesotaMNSt. Paul, MN24984030http://jobs.sjm.com/xml/24984030/jobUSAMinnetonkaProcess Engineer II, New Product Development Job Requisition #: AF13664 Date Posted: 12/12/2011 Category: Engineering Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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 Process Engineer in the Advanced Process Development group to design and implement robust, capable manufacturing processes to facilitate production of high quality medical devices. Impact this role will have within the AF division: Responsible for developing manufacturing processes that are capable of achieving design requirements as well as manufacturing requirements from the laboratory through pilot plant and manufacturing scale. Proactively participate in cross-functional teams focused on design for manufacturability of new products. Team contributor in the efforts to design, develop and continuously improve manufacturing processes. Provides guidance regarding implications of potential design change considerations to manufacturing. Understands relationships between materials selected and processes utilized. Analyze product design to develop, characterize and optimize process technologies. Identify and develop equipment specifications and tooling required. Work with internal or external vendors to fabricate necessary equipment and fixtures. Investigate and evaluate external process technologies. Lead justification and purchase of new capital equipment and/or upgrades of existing capital equipment. Develop master validation plans and PFMEAs, complete process validation activities as required including equipment qualification. Design and implement validation protocols for process improvements including comprehensive engineering reports providing analysis of results. Support developed processes through implementation and assist manufacturing personnel with the transfer to production phases. Communicate project or task purpose, scope, schedule, team roles and responsibilities and metrics to other team members and/or to management. Required Qualifications: Bachelors degree in an Engineering or Science discipline, advanced degree preferred. Minimum, two years experience in process development with manufacturing equipment. Experience with process development including characterization, process optimization and validation using statistical tools such as DOE, Gage R&R, FMEA, and Capability analysis. Strong problem solving skills with Design for Manufacturing and Design for Six Sigma experience preferred. Experience with equipment and tooling design including machine specifications. Must have proven ability to write protocols, reports and technical plans. Ability to provide innovative solutions to complex problems. Ability to multi-task and prioritize responsibilities to ensure deadlines are met in a fast-paced environment. Have the ability to work independently as well as a member of a team. 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. 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.United StatesSt Jude Medical2011-12-12 21:45:30MinnesotaMNMinnetonka, MN25308321http://jobs.sjm.com/xml/25308321/jobUSACardio-PlymouthAnalyst - Product Surveillance Job Requisition #: 11689 Date Posted: 09/15/2011 Category: Quality Location: Cardio-Plymouth - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview The Senior Product Surveillance Analyst is responsible for analyses and control of complaints received from external customers in compliance with FDA, ISO and QSR guidelines. This role facilitates all complaint investigation activities with cross functional team members and prepares complaint investigation reports. Responsibilities: Investigates customer complaints daily related to product quality and patient safety Maintains oversight of the complaints and daily processes to ensure issues are being addressed in a timely and thorough manner and conform to complaint policy and procedures oThis includes performance of data entry, maintenance, filing, and report generation for various aspects of complaint/product handling per standard responsibilities Performs investigative tasks to determine root cause and resolution of identified complaints. This includes interactions with appropriate stakeholders including but not limited to customers, medical professionals, field staff and company affiliates to obtain information pertinent to investigations Works closely with the Engineering, Quality and support departments to complete complaint analysis and document investigation results Makes Adverse Event Reportability decisions in accordance with US and International regulations Generates Medical Device Reports (MDRs) and Vigilance Reports Analyzes and trends Complaint data periodically to identify new and/or systemic issues as necessary Design and distribute data reports to clinical, sales, marketing and production teams in order to facilitate communication and understanding of systemic issues Prepares responses to customers and field as necessary per process Trains and guides other employees on reporting regulations Participates in development, maintenance and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures QUALIFICATIONS: B.S. degree in healthcare, science, or related field (Prefer RN certification) Minimum of five (5) years of experience in a quality or manufacturing environment or clinical experience Prefer experience with FDA and/or ISO regulations for device manufacturing Possess prudent and practical decision-making abilities, good written and verbal communication skills, and ability to work independently without direct supervision, good organizational skills, and effective interpersonal skills Possess the ability to manage many tasks and in an organized fashion Possess intermediate computer skills, computer software and PC experience, including Excel, Word, Outlook and PowerPoint, etc Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-15 18:08:35MinnesotaMNCardio-Plymouth, MN23640434http://jobs.sjm.com/xml/23640434/jobUSAMinnetonkaEngineer - Quality Job Requisition #: 12017 Date Posted: 12/01/2011 Category: Engineering Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. 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.United StatesSt Jude Medical2011-12-01 22:16:22MinnesotaMNMinnetonka, MN25141265http://jobs.sjm.com/xml/25141265/jobUSASt. PaulRecruiter Job Requisition #: Corp 12010 Date Posted: 01/20/2012 Category: Human Resources 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 We are growing and this new position will be responsible for full life-cycle recruiting at our Corporate Headquarters. This role will source, qualify and hire people for business groups and/or hiring managers. Utilize your experience with creative sourcing methods, negotiating techniques, and networking abilities to fulfill hiring objectives. This position will also be involved in HR projects as needed. Preference will be given to local candidates. Responsibilities: Partner with hiring managers to develop recruiting strategies to fill open positions and to meet overall quarterly and yearly recruiting goals Perform searches for qualified candidates utilizing a variety of sources including social media, online job boards, networking, cold calls, and employee referrals Initiate contact with perspective candidates to inform them of employment opportunities, conduct behavioral-based interviews and match candidate qualifications with company needs Maintain a high-touch approach with candidates keeping them informed at each stage of the interview process to ensure a positive candidate experience and to build our employment brand Working with hiring managers and HR team members, manage the selection, offer, negotiation, closing, and administrative processes related to hiring Support equal employment opportunity and diversity goals including accurate maintenance of applicant tracking records Lead and/or participate in cross functional HR projects typically these will be projects related to recruiting, recruiting metrics, affirmative action, employment branding or social media Continually seek innovative, cutting-edge approaches to the recruitment of high-caliber and diversity candidates Participate in recruitment events as needed Required Qualifications: Bachelors degree 5 years full life-cycle corporate recruiting experience to include applicant tracking system experience o 2 of the 5 years should include IT, Engineering or high tech recruiting experience Demonstrated knowledge of technical staffing and recruitment techniques including outstanding knowledge of best in class recruitment strategies and experience in leveraging technology to deliver valuable talent to the organization Demonstrated knowledge and use of behavioral based interviewing Experience in the development of effective sourcing strategies to support talent acquisition efforts including creative approaches to staffing challenges and opportunities 2 years vendor management experience to include external agency contract review and rate negotiation 2 years recruiting metrics experience including the ability to create Excel spreadsheet reports and Google Analytics 2 years active social media recruiting experience such as LinkedIn and Twitter 2 years project management experience - work on special projects, both assisting and leading as needed preference will be given to candidates with recruiting metrics, affirmative action, social media project experience Self motivated with excellent planning, organizational and documentation skills including the ability to set and execute on recruiting goals Working knowledge of Affirmative Action and EEO goals in support of the recruitment process and the ability to keep accurate records in the applicant tracking system Understanding of compensation administration as it relates to creating compelling employment offers Accountable for results and open to feedback Excellent oral and interpersonal communication skills (listening, persuasion, persistence, negotiation, and abilities to follow and drive a process). This includes the ability to interact with, support and build relationships with customers, candidates and vendors. Strong problem resolution skills Ability and desire to work under pressure Strong work ethic Ability to travel, up to 10% PHR or SPHR certification is a plus |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-20 22:58:59MinnesotaMNSt. Paul, MN26017349http://jobs.sjm.com/xml/26017349/jobUSASt. PaulDirector of Clinical CV/NM Job Requisition #: ID11731 Date Posted: 12/29/2011 Category: Clinical Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview The International Division Director, Clinical Studies is responsible for partnering with International Clinical, Marketing teams along with Product Division Clinical and Marketing teams to develop and execute strategic plans which support International business growth goals. This includes setting direction for pre-market and post market clinical projects to support scientific publications, regulatory and reimbursement applications, new product launches, health economics evidence, therapy acceptance and adoption. TYPICAL DUTIES AND RESPONSIBILITES Direct Clinical Strategy through: oCollaboration with Product Division, Geography and country stakeholders oDirect the development, implementation and management of clinical protocols, investigational plans, submissions and clinical trial agreements oRemain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. oSolicit, develop, assimilate, and disseminate data regarding emerging and evolving indications, methods , and SJM technologies This includes driving publication strategies abstract presentation at scientific symposia, or internal white paper. oConsultation to development of technical memoranda, and related documents. Provide consultation to project teams as needed for clinical issues. oOversee clinical input to project teams including risk analysis documentation, clinical evidence summaries, clinical use,and evidence generation required for reimbursement and market acceptance. oCreate new relationships and collaboration with existing KOLs for international clinical and marketing initiatives oCollaborate with ID Marketing and ID Reimbursement to assure effective clinical investigations and product launches oLead and participate in product strateg y roundtables and other Physician Round Tables type meetings, Key Opinion Leader mapping and strategy development oEstablish customer and/or site recruitment plan Support commercial strategy development: oStrengthen and guide Clinical Marketing; i.e. marketing and promotion of SJM clinical projects and results oAdvise geographies on publication strategy to support marketing goals oPartner with Geographies to maximize Academic Center/Emerging KOL programs, initiatives and strategies oDevelop and review literature/documents/materials and select and/or summarize such for distribution in support of marketing initiatives oRecognize, evaluate and take action on out of scope activities Serve as senior customer facing SJM representative to customers oRepresent SJM at external meetings such as congresses, investigator meetings, scientific association meetings including conducting scientific/medical presentations oInteract and consult with physicians, scientific societies (e.g. ESC, EHRA) and other appropriate personnel in the health services and health delivery industries, government, health policy organizations and with appropriate university, corporate, and governmental medical research personnel. oInteract with internal and external teams to support commercial strategies oSupport Government Affairs activities to improve therapy access, reimbursement and regulatory policy Support and coordinate International Clinical Investigation oExecute project management tasks for international projects oReport activities on respective franchises projects Support Product Division strategy and tactics oProvide consult and support for customer communication on SJM product performance, product issues, FERs oSupport Business Development evaluations, technology assessments and other due diligence activities oPartner with Product Development and International clinical teams to monitor patient safety on-site address protocol violations MINIMUM QUALIFICATIONS PhD A minimum of ten plus years of progressively responsible relevant clinical, regulatory, and/or broad medical research experience Demonstrated background and practical experience advising the design and implementation of pre and post market clinical trials Demonstrated background in partnering with upstream and downstream marketing teams to identify, develop, and commercialize best in class medical device products Strong verbal and written communication skills, interpersonal skills, and analytical skills Proven ability to work autonomously and as part of a team Thorough understanding of International regulatory standards PREFERRED QUALIFICATIONS Previous experience presenting at medical congresses and/or symposiums Previous experience advising international medical device marketing and clinical teams Multi-lingual written and verbal fluency TRAVEL REQUIREMENTS 40% international travel is typical. Up to 60% travel at times is likely based on domestic and international travel combined PHYSICAL DEMANDS/WORK ENVIRONMENT Position requires sitting for extended periods of time, walking, traveling globally via plane, car and train, placing and accepting calls in morning and evenings to accommodate international office working hours, and light lifting. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-12-29 22:57:00MinnesotaMNSt. Paul, MN25607922http://jobs.sjm.com/xml/25607922/jobUSAMinneapolisClinical Specialist, Structural Heart Job Requisition #: USD 9387 Date Posted: 01/02/2012 Category: Sales Location: Minneapolis - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position available in our US Sales Division. Job Overview As a member of the clinical support team within an assigned geography, is responsible for providing technical clinical expertise and support of the sales process to colleagues, current customers and/or potential customers. Works under moderate direction with clinical and sales teammates to identify and capitalize on sales opportunities by creating competency, comfort and expertise with all SJM Structural Heart technologies among physician, Cath Lab / CVOR allied health professionals within assigned geography. Performs work that involves a high degree of independence. Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager. Requirements/Education: Registered Nursing Degree (RN), Certified Radiology Technician (CRT), or Cardiovascular Technician (RCIS). BS in related field highly desirable. Minimum 3-4 years experience in interventional cardiology to include hemodynamic monitoring and hemostasis management experience. Solid knowledge in cardiovascular science and medical devices industry. Quick learner ability to come up to speed quickly on all SJM products and services. Good presentation skills, ability to present material comfortably. Good teaming, networking, communication (written/Verbal), win-win relationship building. Ability to work positively through confrontation and/or conflicting ideas. Computer proficiency in Microsoft Office required. Desired Requirements: At least one year prior industry experience and advance degree preferred. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-02 18:51:08MinnesotaMNMinneapolis, MN25657638http://jobs.sjm.com/xml/25657638/jobUSAPlymouthManager - Product Marketing Job Requisition #: 11901 Date Posted: 11/02/2011 Category: Marketing Location: Plymouth - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Responsibilities: Design marketing plan for SHD through all channels including: Conferences, sales force, distributor, publication strategy, etc Develop KOL strategy for conferences and publications and in managing overall physician relations Drive Revenues: Ensure that global Distributor and direct Sales organizations are fully supported and prepared with the knowledge and tools necessary to capitalize on revenue growth opportunities. Implement product promotion programs which include assisting in the creation, maintenance and upgrading of all collateral material including brochures, spec sheets, slides, case studies, launch kits, and reference manuals; ensuring proper internal review is complete and monitoring competitive activity and product positioning. Collaborate with Clinical and R & D: Represent Marketing on product development teams in order to provide marketing leadership, customer input on product enhancements and/or new product development, and execution of product launch per corporate objectives. Major focus will be on pre-market approved products and new product platforms. Develop and maintain product training on key messaging and competitive positioning. Trade show and conferences activities when relevant (US, International). Drive Supply and Operations: work with Operations, Supply Chain, Sales and Clinical to ensure that product forecasting is complete to establish and maintain adequate inventories for products. Become expert on SHD products and their application. Qualifications: BS/BA in business or health sciences. MBA preferred. Five years experience in marketing with prior experience in EP or Interventional Cardiology 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 communications skills for both internal and external customers. Ability to make large, interdisciplinary group presentations. Financial analysis skills to enable support of corporate strategic decisions. Budgeting skills. Basic computer skills, Word, Excel 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.United StatesSt Jude Medical2011-11-02 20:05:55MinnesotaMNPlymouth, MN24546993http://jobs.sjm.com/xml/24546993/jobUSASt. PaulPrincipal Product Development Engineer Job Requisition #: AF13659 Date Posted: 12/09/2011 Category: Engineering Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minnesota, St. Jude Medical employs approximately 14,000 people worldwide and has four focus areas that include: atrial fibrillation, cardiac rhythm management, cardiovascular and neuromodulation. The Atrial Fibrillation Division (AFD) is committed to hiring world class talent that will continue to drive us to lead the way in the treatment and cure for atrial fibrillation. St. Jude Medical is the only medical device company to dedicate a business unit solely to diagnosing, treating and curing atrial fibrillation, the world's most common cardiac arrhythmia. Principal Engineer, Product Development We are seeking an experienced, high caliber Principal Engineer of Product Development to develop and/or investigate new technologies for possible incorporation into EP diagnostic and ablation products. Impact this role will have within the AF division: Evaluate new or existing technologies for treating cardiac arrhythmias. Develop, design, prototype and evaluate technologies that extend our clinical capabilities and technical leadership. Evaluate new technologies for potential implementation into existing product lines. Support new technology development through incorporation of output into new products or capabilities. Intellectual property development document and submit potential IP output for patent consideration. Participate in pre-clinical research activities to also include planning and executing studies. Required Qualifications: Bachelors degree in engineering or science Minimum 8-10 years experience in catheter design and development Demonstrated ability to consistently translate clinical or technological needs into functional system requirements Proficient interpersonal and presentation skills Effective analytical and organizational skills Demonstrated ability to communicate effectively with employees, management and customers Strong technical skills in the area of prototype and process development and related testing Proficient with conventional office software Word, Excel, PowerPoint etc CAD experience SolidWorks or Pro/E 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: Working knowledge of cardiac anatomy Masters degree in engineering or science Working knowledge of the requirements and practices in the field of electrophysiology, tissue ablation and/or cardiac rhythm management 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.United StatesSt Jude Medical2011-12-09 21:57:05MinnesotaMNSt. Paul, MN25280488http://jobs.sjm.com/xml/25280488/jobUSAMinnetonkaSr. SAP Support Analyst Job Requisition #: Corp 11108 Date Posted: 11/15/2011 Category: Information Technology Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview As part of the SAP Support team, the SAP Production Support Analyst will provide direct day-to-day functional production support in one of the following SAP modules: FI/CO, APO or CRM/SD. This includes day to day issue management and resolution activities which follow all production support processes in order to meet established service level agreements. In addition, this position will assist SAP support leadership in providing work directions to other team members in the module specific support areas. This position reports to the Production Support Lead and works directly with the business users and other team members to provide solution for SAP issues. Essential Functions: ? Provide SAP FI/CO, APO or CRM/SD support for a global install base. ? Work with SAP production support team and serve as a resource to provide solutions on production issues. ? Direct day-to-day functional support of SAP issues. ? Provide support for Month End, Quarter End and Year End activities. ? Provide support for SOX SOP related issues. Help with development of business processes. ? Provide support for cross functional testing and integration issues with other modules. ? Hands-on configuration of SAP modules. ? May support other business areas and/or applications in addition to SAP FI/CO, APO or CRM/SD. ? Participate in change management processes for SAP module area. Other Duties: Help to develop knowledge management content to be leveraged by Level 1 support staff and end-users for SAP FI/CO, APO or CRM/SD area. Provide Level 2 on-call support for non-core hours of operation. Qualifications: Four year degree in computer science, information systems, business or equivalent. 5+ years experience is required in one or more of the following: o SAP FI/CO module in a support environment. Thorough knowledge of FI: A/P, A/R, G/L, F/A,CO: CCA, Assessments and Product Costing; or o SAP SCM 4.0 in a support environment. Must be strong in DP, SNP and GATP modules; or o SAP CRM/SD in a support environment. Experience with CRM 5.0, ECC 5.0, FI/CO, CRM/SD, GTS and BW desired Functional experience in once of the following will be a plus: o SD, MM, PP, CRM, FI/CO Experience with service management tools such as Remedy or SAPs Solution Manager preferred. Excellent interpersonal and communication skills. Excellent root cause analysis skills. Ability to travel, up to 5%. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-15 21:11:32MinnesotaMNMinnetonka, MN24881323http://jobs.sjm.com/xml/24881323/jobUSASt. PaulManager - Commodity Job Requisition #: 12302 Date Posted: 01/24/2012 Category: Purchasing 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 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, 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 Qualifications: 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.United StatesSt Jude Medical2012-01-24 20:55:03MinnesotaMNSt. Paul, MN26086252http://jobs.sjm.com/xml/26086252/jobUSAMinnetonkaSr. Project Manager, EIT Job Requisition #: Corp 12006 Date Posted: 01/13/2012 Category: Information Technology Project Management Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview The Project Manager has overall accountability and responsibility to plan and manage the resources and processes used to develop and implement strategic and tactical enterprise systems projects. The Sr. Project Manager is involved in the management of all task activities and 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. The Enterprise IT (EIT) group is responsible for infrastructure and systems that are used globally across the multiple St Jude Medical divisions. The EIT Project Management Office staff provides project manage support for a breadth of initiatives across EIT. This position is focused on managing multiple midsized projects and enhancements for our SAP ERP and Business Warehouse (BW) reporting applications. Essential Functions: Conduct initial project investigations including the assessment of business, competitive, industry, technology and user/task trends to identify the value-add for projects and to obtain business partner sponsorship. Manage strategic IT projects including: Working with the business to define technical requirements . Scope definition and management. Maintaining an accurate schedule depicting individual or group tasks, provide status reports. Monitor project progress and problem solve when issues arise. Developing and delivering quality systems within defined budgets. Risk analysis and management. Contingency planning. Preparing for change management communications or training development. Coaching and training and assessing job performance of all team members. Team building. Overall project control and coordination. Develop and execute project plans utilizing a project management methodology and project planning tools. Provide day-to-day work direction for project teams and accountable for clear and achievable expectations and roles. Collaborate with other project managers to assure a consistent implementation of the St. Jude Medical application development/infrastructure and project management disciplines and methodologies. Identify and engage stakeholders . Monitor project status and report to senior management or steering committee. Conduct formal presentations to management and provide written status project updates. Develop and maintain an outstanding customer service relationship with business, division IT management, and team members. Train and mentor others. Determine methods and procedures on new assignments. Other Duties: Manage staff functions and/or assisting PMs or Project Coordinators. As assigned. Qualifications: Bachelor's degree in Business, Computer Science, Engineering or related field. MBA and experience in Medical Device or Life Science industries is a plus. Project Management certification is a plus. 8+ years of overall IT experience using a standard IT methodology(s). 6+ years in a project leadership role performing project planning and implementation. Proven experience managing enterprise-wide projects and leading cross-functional teams of high performance contributors, vendors, and multiple geographies. International experience is a plus. Proven experience managing multiple projects of varying size at a given time. Experience managing programs and/or project portfolios is a plus. Strong business and systems knowledge including expertise in a given functional area. Experience working with ERP Systems (add : such as PeopleSoft, Oracle, Lawson). SAP experience not required but a plus. Experience performing, and willingness to perform, business analysis tasks Experience implementing or improving IT processes. Self motivated with excellent planning, interpersonal, organizational, documentation, verbal and written communication skills. Ability to bridge communication between technical and business areas for a full and complete understanding of expectations. Ability to execute issue identification and resolution. Excellent logical, analytical, and problem solving skills. Experience with MS Project, Excel, Word and Visio. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-14 01:32:09MinnesotaMNMinnetonka, MN25899615http://jobs.sjm.com/xml/25899615/jobUSASt. PaulParalegal II Job Requisition #: AF13673 Date Posted: 01/13/2012 Category: Legal Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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, Paralegal II. The successful candidate will be responsible for assisting the General Counsel in providing legal support internally for the division. Essential Functions: Support General Counsel by providing research, file management, docketing, and administration related to general legal matters. Maintain complete legal files for all non intellectual property matters. Draft legal documents such as confidentiality agreements, consulting agreements, and supply chain agreements for review and approval by counsel. Draft clinical study agreements and amendments. Assist with annual AdvaMed and state mandated compliance audits. Assist in creating reports disclosing AFDs interactions with health care professionals. Assist with compliance training efforts by communicating training schedules to senior management, responding to questions and monitoring completion status during active campaigns. Prepare Compliance Committee meeting agendas and minutes; maintain records. Assist with filing legal correspondence and legal documents in office filing system. Required Qualifications: Bachelor degree. 4+ years of Paralegal experience, including substantial contract drafting experience. 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. Previous experience in the medical device industry. Preferred Qualifications: Advanced degree or paralegal certificate. Prior experience in a compliance role preferred. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-14 01:32:09MinnesotaMNSt. Paul, MN25899614http://jobs.sjm.com/xml/25899614/jobUSASt. PaulDirector of Clinical Job Requisition #: ID11730 Date Posted: 12/28/2011 Category: Clinical Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview The International Division Director, Clinical Studies is responsible for partnering with International Clinical, Marketing teams along with Product Division Clinical and Marketing teams to develop and execute strategic plans which support International business growth goals. This includes setting direction for pre-market and post market clinical projects to support scientific publications, regulatory and reimbursement applications, new product launches, health economics evidence, therapy acceptance and adoption. TYPICAL DUTIES AND RESPONSIBILITES Direct Clinical Strategy development through: oCollaboration with Product Division, Geography and country stakeholders oDirect the development, implementation and management of clinical protocols, investigational plans, submissions and clinical trial agreements oDirect the development and execution of trail strategy, design, protocol writing, training, monitoring, documentation, and data analysis to support filings for product approval and clearances, expansion of claims and product reimbursement oResponsible through lower management levels for directing the technical support of Company products ensuring that all questions from the field and from internal sources are answered. oAssist the Training and Education Department in the generation of educational materials and the conduct of educational programs. oRemain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. oResolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence. oSolicit, develop, assimilate, and disseminate data regarding emerging and evolving indications, methodologies, and technologies involved in various therapies. This includes driving publication strategies revolving around preclinical and basic science research with ensuing publication as journal article, abstract presentation at scientific symposia, or internal white paper. Oversees the development of technical memoranda, product manuals, and related documents. As necessary, revises such manuals, protocols, training materials and tests as required. oProvide consultation to project teams as required for clinical issues. Responsible for the oversight of clinical input to program management teams including risk analysis documentation, clinical evidence summaries, clinical use, instructions for use and evidence generation required for field and market acceptance. oCreate new relationships and collaboration with existing KOLs for various international clinical and marketing initiatives oCollaborate with ID Marketing and ID Reimbursement to assure high quality clinical investigations and product launches oLead and participate in product strategy roundtables and other Physician Round Tables type meetings, Key Opinion Leader mapping and strategy development oEstablish customer and/or site recruitment plan Support commercial strategy development: oStrengthen and guide Clinical Marketing; i.e. marketing and promotion of SJM clinical projects and results oAdvise geographies on publication strategy to support marketing goals oPartner with Geographies to maximize Academic Center/Emerging KOL programs, initiatives and strategies oDevelop and review literature/documents/materials and select and/or summarize such for distribution in support of marketing initiatives oRecognize, evaluate and take action on out of scope activities Serve as senior customer facing SJM representative to customers oRepresent SJM at external meetings such as congresses, investigator meetings, scientific association meetings including conducting scientific/medical presentations oInteract and consult with physicians, scientific societies (e.g. ESC, EHRA) and other appropriate personnel in the health services and health delivery industries, government, health policy organizations and with appropriate university, corporate, and governmental medical research personnel. oInteract with internal and external teams to support commercial strategies oSupport Government Affairs activities to improve therapy access, reimbursement and regulatory policy Support and coordinate International Clinical Investigation oExecute project management tasks for international projects oReport activities on respective franchises projects Support Product Division strategy and tactics oProvide consult and support for customer communication on SJM product performance, product issues, FERs oSupport Business Development evaluations, technology assessments and other due diligence activities oPartner with Product Development and International clinical teams to monitor patient safety on-site address protocol violations MINIMUM QUALIFICATIONS PhD A minimum of ten plus years of progressively responsible relevant clinical, regulatory, and/or broad medical research experience Demonstrated background and practical experience advising the design and implementation of pre and post market clinical trials Demonstrated background in partnering with upstream and downstream marketing teams to identify, develop, and commercialize best in class medical device products Strong verbal and written communication skills, interpersonal skills, and analytical skills Proven ability to work autonomously and as part of a team Thorough understanding of International regulatory standards PREFERRED QUALIFICATIONS Previous experience presenting at medical congresses and/or symposiums Previous experience advising international medical device marketing and clinical teams Multi-lingual written and verbal fluency TRAVEL REQUIREMENTS 40% international travel is typical. Up to 60% travel at times is likely based on domestic and international travel combined PHYSICAL DEMANDS/WORK ENVIRONMENT Position requires sitting for extended periods of time, walking, traveling globally via plane, car and train, placing and accepting calls in morning and evenings to accommodate international office working hours, and light lifting. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-12-28 18:29:56MinnesotaMNSt. Paul, MN25581130http://jobs.sjm.com/xml/25581130/jobUSAMinnetonkaEngineer - Process Development Job Requisition #: 12322 Date Posted: 01/26/2012 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 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 7+ 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.United StatesSt Jude Medical2012-01-26 22:21:20MinnesotaMNMinnetonka, MN26140010http://jobs.sjm.com/xml/26140010/jobUSASt. PaulSenior Industrial Engineer Job Requisition #: 12291 Date Posted: 01/26/2012 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 Sr. Industrial Engineer Duties and Responsibilities: Support, optimize & standardize the manufacturing, packaging & sterilization of a tissue valve product line. Manage key global efficiency improvement projects which may include new process layouts, process improvements and cost reductions while supporting current production needs. Provide cross functional global guidance for lean standardization. Additional responsibilities include: Support current production with efficiency metrics and reaction plans Provide technical mentorship to engineers and technicians Conduct visual staffing planning and value stream mapping Create templates and standardization documentation to support global rollout of key lean initiatives Work with Product Development to ensure lean concepts and line flow/layout are in adherence to commercial production standards 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: B.S. in Industrial Engineering 5+ years of lean engineering experience in the Medical Device or highly regulated industry required Proven ability to work independently and lead project teams 5+ years of extensive knowledge in lean tools, implementation and standardization Excellent working knowledge of cellular manufacturing, standard work, work content and 5S required Demonstrated leadership capability in team settings Black Belt Certification or formal training required Excellent presentation and communication skills required Ability to develop and author training materials Willing to travel 30% (Costa Rica and Brazil) |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-26 22:22:01MinnesotaMNSt. Paul, MN26140050http://jobs.sjm.com/xml/26140050/jobUSASt. PaulSenior Clinical Research Associate Job Requisition #: 11824 Date Posted: 10/07/2011 Category: Clinical Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview The Senior Clinical Research Associate plans, designs, and executes high quality clinical studies to ensure the safety and effectiveness of SJM products. This role ensures compliance to applicable regulatory standards. The focus is on study management activities and monitoring of investigational centers. Essential Functions: Develops clinical protocols, case report forms, study manuals, in collaboration with Clinical Manager Reviews and approves site activation documentation Qualifies and initiates sites, including scheduling monitor activities with site personnel Assists in planning and preparing materials for investigator and coordinator meetings in collaboration with Clinical Manager Trains investigators and coordinators Tracks and reports study progress, e.g. subject screening and enrollment, data collection, documentation of adverse events Coordinates and conducts monitoring visits to ensure compliance to the clinical protocol, regulations and timely receipt of data Oversees activities by CROs Provides input to study budgets and project plans Assists clinical manager by providing input to sections of the Investigational Plan, clinical reports, and abstracts/manuscripts Manages smaller studies Provide clinical scientific support to core development teams Manage core lab data Prepares study summary reports for presentations, publications and submissions Develops and implements site corrective actions Qualifications Bachelors degree 5-7 years experience supporting clinical research 3 years experience monitoring sites Knowledge of clinical and outcomes research study design Proficient knowledge of medical terminology Expertise with GCPs, and regulatory compliance guidelines for clinical trials High attention to detail and accuracy Advanced written and oral communications skills Able to manage multiple tasks Good problem-solving skills Proficient computer skills (MS Office) Demonstrated ability to work effectively on cross-functional teams Able to travel 50% on average and up to 80% during peak periods Current drivers license |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-10-07 19:48:40MinnesotaMNSt. Paul, MN24103726http://jobs.sjm.com/xml/24103726/jobUSASt. PaulSenior Process Development Engineer Job Requisition #: 11917 Date Posted: 10/31/2011 Category: Manufacturing Process Development Engineering Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul. Job Overview Senior Process Development Engineer Duties and Responsibilities: Manage process development projects and activities which include new production equipment, creation or enhancement of new processes, general manufacturing improvements and cost reductions. 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 Work with R&D and DA 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: Mechanical , Chemical or any engineering or technical degree required 7+ years manufacturing or process development engineering experience Medical device experience is a must 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.United StatesSt Jude Medical2011-10-31 19:45:17MinnesotaMNSt. Paul, MN24505378http://jobs.sjm.com/xml/24505378/jobUSAMinnetonkaEngineer - Process Development Job Requisition #: 11635 Date Posted: 09/07/2011 Category: Engineering Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Position Summary: This position will design and develop electrical testing, tooling, and fixtures to support new product development and improve established production processes while enhancing productivity and product quality. Essential Functions: Develop and implement new electrical tests and improvements for RF catheter 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: Electrical Engineering degree required 7+ 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.United StatesSt Jude Medical2011-09-07 18:51:47MinnesotaMNMinnetonka, MN23465512http://jobs.sjm.com/xml/23465512/jobUSAPlymouthSenior Clinical Research Associate Job Requisition #: 12020 Date Posted: 12/08/2011 Category: Clinical Location: Plymouth - MN - USA About Us St.Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview As a Senior Clinical Research Associate you will manage the planning, designing, and execution of high quality clinical studies to ensure safety and effectiveness of SJM products. Ensures compliance to applicable regulatory standards. Focus is on study management activities and oversees monitoring of investigational centers. Essential Functions: Assists with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools. Reviews and approves site activation documentation Participates in site qualification and site initiation process, including scheduling of monitor activities with site personnel. Assists in planning and preparing materials for investigator and coordinator meetings. Assists in training of investigators and coordinators. Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events. Coordinates and conducts 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 Oversees activities by CROs Assists in query generation and resolution. Provides input to study budgets and project plans. Assists clinical manager by providing input to sections of the Investigational Plan, clinical reports, and abstracts/manuscripts. Provide clinical scientific support to project teams. Assist with core lab data management. Assists with preparation of study summary reports for presentations, publications and regulatory submissions for FDA (510(K), IDE/PMA). Assists with the development and implementation of site corrective actions as needed to address any noncompliance issues. Assumes study management responsibility for smaller studies Has technical knowledge of product Writes and/or provides input to the monitoring plan 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: Bachelors degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. 2-5 years experience directly supporting clinical research or similar experience in a medical/scientific area. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience. High attention to detail and accuracy. Advanced written and oral communications skills. Able to manage multiple tasks. Knowledge of clinical and outcomes research study design Proficient knowledge of medical terminology. Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). Good problem-solving skills. Knowledge of clinical and outcomes research study design. Proficient computer skills (MS Office) Demonstrated ability to work effectively on cross-functional teams Able to travel 50% on average and up to 80% during peak periods may be required. Current drivers license |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-12-08 18:56:00MinnesotaMNPlymouth, MN25251480http://jobs.sjm.com/xml/25251480/jobUSASt. PaulSr. Auditor Job Requisition #: Corp 11107 Date Posted: 11/10/2011 Category: Finance Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview Assess effectiveness of financial related business processes and controls including SOX controls at domestic and international locations. Identify the most effective and efficient approaches to mitigate risks and continually evaluate the effectiveness of processes in place. Promote the process of continuous monitoring of controls and risk management, and work with management to develop potential solutions for issues identified. Exercise judgment in planning and organizing work. Perform special assignments and projects as directed. Essential Functions: Perform Sarbanes-Oxley audit procedures such as review of internal control documentation, perform walk-through of key business processes, perform test of key controls to ensure they are operating effectively, and evaluate deficiencies identified during testing. Create clear and accurate documentation of processes and controls as well as test results and conclusions. Lead audits as the in-charge auditor. Assist with performing the annual financial and fraud risk assessment and identification of new or emerging risks. Develop audit programs including steps to test effectiveness of controls in place to address risks. Report (orally and in writing) on the results of work performed including recommendations for deficiencies identified. Assist with other projects as necessary in conjunction with the Annual Internal Audit Plan. Establish positive working relationships with management and provide input on risks and controls while maintaining independence and objectivity. Assist project teams with the identification and design of key financial-related controls in conjunction with the SAP implementation. Company acquisition or disposition activities as assigned. Perform other related tasks as assigned. Qualifications Required: Bachelors degree in Business, Accounting, or a related field. 3+ years public accounting and/or audit experience with large company. 2+ years project management experience including the ability to organize, plan, prioritize and complete assignments with little or no supervision. Strong understanding of Sarbanes-Oxley and related processes and controls. Excellent oral, written and presentation skills. Strong analytical skills. 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 policies and procedures. Ability to travel domestically and internationally (up to 30%). Qualifications Desired: CPA or other certification (CISA, CIA) strongly desired. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-10 21:34:54MinnesotaMNSt. Paul, MN24812182http://jobs.sjm.com/xml/24812182/jobUSAMaple GroveIntern - Business Development Job Requisition #: 11921 Date Posted: 11/14/2011 Category: Internship Location: Maple Grove - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Summary: Work closely with SJM business groups and cross-functional leadership to execute strategies that drive opportunities in SJMs 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 SJMs 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 required; finance or marketing degree preferred. Enrollment in accredited MBA program required. Prefer 1st year MBA student. A minimum of two years of investment banking, private equity or business development experience preferred. 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.United StatesSt Jude Medical2011-11-14 19:22:38MinnesotaMNMaple Grove, MN24853532http://jobs.sjm.com/xml/24853532/jobUSAPlymouthManager - Supply Chain Job Requisition #: 12074 Date Posted: 12/19/2011 Category: Manufacturing Logistics Operations Location: Plymouth - MN - USA About Us St.Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. 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 JD Edwards One World ERP experience preferred LEAN and/or Six Sigma experience required |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-12-19 20:08:11MinnesotaMNPlymouth, MN25453141http://jobs.sjm.com/xml/25453141/jobUSAMinnetonkaMfg Maintenance Tech II - 2nd Shift Job Requisition #: AF13672 Date Posted: 01/31/2012 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 Maintenance Technician II. The successful candidate will be performing preventative, scheduled and unscheduled maintenance, safety checks, repairs, installations, and modifications on production equipment. This individual will also be responsible for recording all maintenance repair activity on production equipment and fixtures at the Minnetonka facility. Good attendance with minimal unscheduled absences and tardiness required. This is a second shift opportunity. Impacts this role will have: Conduct daily tooling and equipment set ups as required. Complete changes or modifications to production equipment, including the generation of any required engineering change requests. Install custom accessories needed to ready equipment for production. Requisition needed items for inventory, spare parts and emergency repairs. Perform visual inspections of equipment and fixtures. 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: Associates degree and/or completion of two year technical program. 5+ years maintenance technician experience. Knowledge of PLC, servo and stepper controls, sensors, lasers and injection molding. Preferred Qualifications: Bachelors degree. Experience generating engineering change requests. Experience writing and executing equipment installation qualifications (IQs). Medical device industry experience. To learn more or to apply, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-31 21:08:16MinnesotaMNMinnetonka, MN26223600http://jobs.sjm.com/xml/26223600/jobUSASt. PaulCounsel Job Requisition #: 12216 Date Posted: 01/19/2012 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 in St. Paul: Job Overview As Counsel for St. Jude Medical, you will provide expeditious and high quality legal counsel and advice to CVD management and employees regarding CVD's legal rights and obligations. This position will hold primary responsibility for advising the company's Supply Chain operations on a variety of legal issues. RESPONSIBILITIES: Provides legal counsel to CVD management and employees on the legal aspects of activities within their assigned areas with a particular emphasis on supply chain issues and contractual relationships Prepares and renders legal opinions and provides research services to the CVD management and employees staff as directed by the General Counsel or Associate General Counsel Develop a comprehensive understanding of the company's businesses and business practices; engage in a participative and proactive style of legal practice in order to best serve internal clients Participates as legal representative on cross-functional teams Participates in the development of the structure and oversees preparation and reviews of contracts and other legal instruments Assists CVD General Counsel, Associate General Counsel and/or Corporate Legal in evaluating initiating legal action against infringements of CVD legal rights, and defending CVD in any legal action initiated against it With guidance from CVD's Associate General Counsel manages, and is responsible for legal services required by CVD, selecting and retaining outside counsel as required Assists with developing, administering and providing legal training programs for employees regarding both general legal topics and topics relating to St. Jude Medical and/or CVD policies Other duties may include preparing and conducting special analyses and projects as required, remaining current on developments in field(s) of expertise, regulatory requirements, as well as industry trends Travel as required to represent the interests of the company REQUIREMENTS: JD or LLB required, including a Bachelor's degree Typically a minimum of 5+ years experience of progressively more responsible work experience in general corporate law, including: corporate and transactional experience with a supply chain focus; regulatory and/or clinical compliance counseling; and the ability to understand complex biomedical devices Eligibility for admission to the Minnesota Bar Experience counseling clients in international operations, including knowledge of both U.S. and foreign national legal environments Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks Ability to work autonomously yet liaise effectively with the business teams and shared services functions as needed (human resources, finance, etc.) Strong organizational skills to prioritize and manage multiple time-sensitive projects simultaneously Excellent oral, written and interpersonal communications skills Ability to work in a fast-paced, results-oriented environment PREFERRED QUALIFICATIONS: Applied legal experience in the medical devices, biomedical, pharmaceutical or related industries Fluency in Spanish or Portuguese A bachelor's or master's degree in business or in a scientific or engineering field |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 18:30:04MinnesotaMNSt. Paul, MN25984942http://jobs.sjm.com/xml/25984942/jobUSASt. PaulIntern - R&D Job Requisition #: 12237 Date Posted: 01/24/2012 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 in our Cardiovascular Division: Job Overview Position Summary: The Intern candidate will serve as a member in the R&D Science & Technology Group interfacing with other departments of the company to work on cross-functional projects. The individual will be directly involved in providing technical expertise, consultation and project support in the area of biocompatibility. He/she will be responsible for reviewing, understanding, categorizing and summarizing biocompatibility testing documents. The individual will also be responsible for writing technical assessments per the ISO 10993 series to support regulatory product approval in different geographies. Duties and Responsibilities: The evaluation of the biocompatibility of materials, i.e. the evaluation of the suitability of materials for use in implantable medical devices, has evolved over approximately the last 50 years. The candidate will be responsible for development programs, materials selection rationales, and biocompatibility strategies applying the Three Rs: reduction (using fewer animals), refinement (using better tests), and replacement (using non-animal tests). This includes developing testing protocols/reports for validations to be performed, assessing, guiding and performing in the area of biocompatibility, chemical characterization, and test method selection and development. Individual should have a fundamental understanding of biomaterials, chemical processes, biological systems, and analytical methodology. Analyze, interpret and draw conclusions from material/biological evaluations. May be required to assist in publication strategies for research activities. Remain current with technology and testing standards. Qualifications: Expertise in Materials Science or Biomedical Engineering with focus on biomedical materials (metals, ceramics, polymers and tissue-derived species) is required. -Current student pursuing M.S. or above in one or more of the following disciplines: Biomedical/Tissue Engineering, Materials Science and Engineering, Biology (Biological Sciences), Biochemistry, or Chemistry; with industrial and/or academic research experience in the area of medical device, pharmaceutical, or biotechnology or combination. -Must be a current student enrolled in Fall Semester of 2012. -Hands-on experience with cell culture. -Experience with blood testing and biological assays is preferred. -Individual must be proficient with computers, and have excellent written and verbal communication skills. -Candidate must work well in collaborative environments across functional areas. -General understanding of the principles associated with biomaterials, synthetic polymers, natural biomacromolecules, tissues, material processing and characterization, biological evaluation of medical materials and devices, biocompatibility. -Familiarity with ISO 10993 and FDA guidelines is a plus. Assignment: Summer Internship Please Note: No housing, transportation, or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-31 21:08:07MinnesotaMNSt. Paul, MN26223598http://jobs.sjm.com/xml/26223598/jobUSAMinnetonkaEngineer - Software Quality Job Requisition #: 12270 Date Posted: 01/31/2012 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: This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. 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. Other Duties: Software scoping and Part 11 audits. Other duties as assigned. 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: 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.United StatesSt Jude Medical2012-01-31 21:07:51MinnesotaMNMinnetonka, MN26223589http://jobs.sjm.com/xml/26223589/jobUSAMinnetonkaGroup Lead - Production Job Requisition #: 12338 Date Posted: 01/31/2012 Category: Production 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: 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 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.United StatesSt Jude Medical2012-01-31 21:07:41MinnesotaMNMinnetonka, MN26223549http://jobs.sjm.com/xml/26223549/jobUSAMinnetonkaMfg & Development Engineering Mgr II Job Requisition #: CRT13027 Date Posted: 06/27/2011 Category: Operations Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. The Cardiac Rhythm Management Division (CRMD) currently has the following position available: Job Overview We are seeking an experienced manager to join our Minnetonka, Minnesota based Cardiac Rhythm Management division team. Within this role, the manager will be responsible for identifying appropriate resource needs and assembling cross-function product development teams. This position will be responsible for the timely support of production, and ensuring that all issues are resolved in a timely manner. Impact this role will have: Provide supportive leadership to lead, coach and mentor a team of development and manufacturing technicians and engineers. Set up goals and objectives for the team members and track progress. Responsibility for full product development, while ensuring compliance to quality, safety and reliability standards. Ensures smooth production line flow by proactively identifying and resolving issues. Enables yield improvement and cost reduction efforts. Provides timely, accurate project updates to senior management. Conducts performance reviews; implement and execute career development plans. Responsibility of workload assessments for annual operating and strategic plans. Recruits, hires, trains and retains high performing team. Required Qualifications: Bachelors degree in Engineering. 10+ years engineering experience. 5+ years of medical device industry product development experience. 5+ years of successful management experience. Demonstrated effective written and verbal communication, interpersonal, and presentation skills. Balanced approach in prioritizing conflicting projects, while constantly negotiating expectations Polished communicator- written documentation and oral presentations/ discussions/ meetings Experience in managing up to 10 engineers and technicians Excellent reputation for building relationships. Organized, on-time, and detailed project management skills with ability to manage small to medium size projects. Energized attitude and self-starter. Preferred Qualifications: Masters degree in Engineering, or MBA 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.United StatesSt Jude Medical2011-06-27 18:49:11MinnesotaMNMinnetonka, MN22039311http://jobs.sjm.com/xml/22039311/jobUSACardio-PlymouthAssociate - Clinical Research Job Requisition #: 11408 Date Posted: 08/10/2011 Category: Clinical Location: Cardio-Plymouth - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Summary: Designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department. Duties and 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. Physical Requirements: Frequent computer monitor and keyboard use. Sitting for long periods of time. Education, Experience, Personal and Technical Skill: BA/BS in business, medical science or nursing (or equivalent experience). 2 - 4 years experience in clinical research, preferably with a medical device company. 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.United StatesSt Jude Medical2011-08-10 19:30:34MinnesotaMNCardio-Plymouth, MN22942734http://jobs.sjm.com/xml/22942734/jobUSASt. PaulSenior Engineer, Analog and Digital Job Requisition #: 11418 Date Posted: 07/19/2011 Category: Engineering Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company based in Westford MA. LightLab Imaging is the world's leading manufacturer and marketer of Optical Coherence Tomography (OCT) for coronary imaging applications, a high resolution diagnostic coronary imaging technology which aids physicians in the treatment of cardiovascular disease. Job Overview Analog/Digital Senior Engineer PRIMARY DUTIES AND RESPONSIBILITIES: LightLab Imaging, a subsidiary of St. Jude Medical, seeks a talented engineer to design RF and digital circuitry for an intraluminal imaging system. The successful candidate will work with a team of hardware engineers on the board designs with special emphasis on the analog circuitry and noise suppression. Requires collaboration with the catheter, software and clinical groups Responsibilities include 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. EXPERIENCE & SKILL REQUIREMENTS: Required:5+ years RF analog and mixed signal design; experience with circuit simulation methods. Bachelors Degree in Electrical Engineering desired. Master Degree Desired Experience with Altium Designer preferred Medical device (especially Optical Coherence Tomography or Ultrasound) or telecommunications development experience |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-07-19 18:40:07MinnesotaMNSt. Paul, MN22480677http://jobs.sjm.com/xml/22480677/jobUSASt. PaulAssociate - Clinical Research Job Requisition #: 11470 Date Posted: 07/29/2011 Category: Clinical Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul. Job Overview Position Summary: Under supervision of the Clinical Manager, the Senior Clinical Research Associate position manages the planning, designing, and execution of high quality clinical studies to ensure safety and effectiveness of SJM products. Ensures compliance to applicable regulatory standards. Focus is on study management activities and oversees monitoring of investigational centers. Essential Functions: Assists with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools. Reviews and approves site activation documentation Participates in site qualification and site initiation process, including scheduling of monitor activities with site personnel. Assists in planning and preparing materials for investigator and coordinator meetings. Assists in training of investigators and coordinators. Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events. Coordinates and conducts monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, query generation and resolution, device accountability, and writing of monitoring visit reports Oversees activities by CROs Provides input to study budgets and project plans. Assists clinical manager by providing input to sections of the Investigational Plan, clinical reports, and abstracts/manuscripts. Assist with core lab data management. Assists with preparation of study summary reports for presentations, publications and regulatory submissions for FDA (510(K), IDE/PMA). Assists with the development and implementation of site corrective actions as needed to address any noncompliance issues. Assumes study management responsibility for smaller studies. Has technical knowledge of product. Writes and/or provides input to the monitoring plan. 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 Qualifications: Bachelors degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. 2-5 years experience directly supporting clinical research or similar experience in a medical/scientific area. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience. High attention to detail and accuracy. Advanced written and oral communications skills. Able to manage multiple tasks. Knowledge of clinical and outcomes research study design Proficient knowledge of medical terminology. Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). Good problem-solving skills. Knowledge of clinical and outcomes research study design. Proficient computer skills (MS Office) Demonstrated ability to work effectively on cross-functional teams Able to travel 50% on average and up to 80% during peak periods may be required. Current drivers license |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-07-29 18:31:04MinnesotaMNSt. Paul, MN22713574http://jobs.sjm.com/xml/22713574/jobUSASt. PaulProduct Manager-AF, Capital Equipment Job Requisition #: ID11722 Date Posted: 01/10/2012 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 The Product Manager is responsible for developing the marketing and business plans that drive assigned Atrial Fibrillation Division products into International markets. To do this successfully, the Product Manager is responsible for understanding customer needs including physician, c-suite, and sales personnel. The Product Manager must be able to translate these customer needs (working closely with the product division) into winning marketing and sales strategies for each product launch. Additionally, the Product Manager must have effective communication, collaboration, influence and interpersonal skills to deliver successful launches in a matrix organization. TYPICAL DUTIES AND RESPONSIBILITIES Plan and prepare product launches in cooperation with the Atrial Fibrillation Product Division and international geographies, and facilitate implementation throughout the geographies Actively manage performance versus objectives by major geography and develop plans, where needed, to ensure objectives are attained Develop strategies and programs designed to move market share and create customer loyalty for SJM Develop strategies and plans to monitor and respond to changes in the market place and competitive activity Provide analyses that highlight sales opportunities, trends and issues Work with the Product Division to represent the International Division viewpoint in the new product development process Prepare monthly updates on assigned pre-market and currently marketed products including metrics, strengths, gaps, strategies to close gaps, etc. Support global tradeshows 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 product related decisions Manage complex projects and programs Interact with field personnel and key hospital stakeholders physicians, nurses, lab managers, techs, c-suite/economic buyers KEY SKILLS REQUIRED Strong individual self starter with demonstrated ability to develop and execute on plans in a matrix environment Strong influence management skillseffectively influences a wide variety of geographies/cultures including Europe, Asia Pacific, Japan, Australia and Canada and functions including regulatory, sales, marketing, research and manufacturing Uses conflict resolution skills to achieve results through cross functional groups Strong team playerability to work as a key member of the International Division marketing team Strong leadership skillsability to function as the marketing lead on high profile projects around the world Project management skills Ability to pull the appropriate functional and geographic functions together to support initiatives Experience in product marketing including market plan development and execution Excellent communication skills Understanding of medical device clinical and regulatory process and environments MINIMUM QUALIFICATIONS BA/BSN/BAN/BS 3+ years sales and/or marketing experience with Medical Device Experience in managing multiple, simultaneous new product launches Skilled in use of spreadsheet, database and presentation software Strong communications and negotiation skills, sensitive to cultural differences Work effectively in a complex, multi-tasking environment Strong analytical, strategic and problem-solving skills required PREFERRED QUALIFICATIONS MBA with marketing emphasis Experience with international markets Experience with Catheters (Disposable product marketing and sales) Experience with Capital products, the maintenance of those products and service agreements 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.United StatesSt Jude Medical2012-01-10 20:57:17MinnesotaMNSt. Paul, MN25811145http://jobs.sjm.com/xml/25811145/jobUSASt. PaulSQL Server DBA 1 Job Requisition #: Corp 12012 Date Posted: 01/25/2012 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 SQL Server DBA executes the day to day work instructions from other members of the team in a professional and timely manner. Learn new skill sets and apply them to the regular work environment. Communicating with other teams effectively while servicing them or availing service from other teams. Will be using the process of elimination to troubleshoot problems and escalate appropriately. Job Duties: Responsible for ensuring the availability and performance of the databases supported by the team. Work in production and non-production environments. Ensuring data is tested, validated and secure before releasing to production. Interact with customers to deliver services. Build databases in standalone, cluster and virtual environments. Proposes and implements enhancements that will improve the performance and reliability of the system. This may include developing scripts and other automation to existing or new processes. Work on improving the processes and procedures through continuous improvement activities. Perform incident and service request execution as directed. Maintain and monitor database security and integrity control. Recommend and implement backup recovery processes. Participate in after hours support call rotation as per the team guidelines and direction. Other duties as assigned. Qualifications Required: Bachelors Degree in computer Science or equivalent 5 years of overall DBA experience with 2 years working with SQL server. 3 years of DBA experience including 1 year working with SQL server. Experience in building and supporting transactional and data warehouse applications in SQL Server 2005 and above. Knowledge of SQL Server architecture with understanding of different database components. Ability to script in VB, .NET and other programming languages and experience in TSQL, SSIS packages. Ability to troubleshoot as needed to remedy issues. Able to work in a team and also take initiative and ownership of assigned tasks. Ability to work after hours in an on-call rotation support schedule. Able to travel up to 25% which may include domestic and international travel. Able to communicate effectively with internal and external customers. Qualifications Desired: Knowledge of industry standard database platforms like Oracle and mySQL. MCTS DBA (Microsoft Certified Technology Specialist for DBA) Certification. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-25 20:51:42MinnesotaMNSt. Paul, MN26111039http://jobs.sjm.com/xml/26111039/jobUSASt. PaulBusiness Analyst - BI Job Requisition #: Corp 12013 Date Posted: 01/25/2012 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 Analyzes business and technical processes, documents business requirements, defines changes to business processes and assists in modifying them, configures, tests and implements enterprise-wide business systems. Interviews business partners to define detailed business requirements. Maps current processes to the desired state and identifies gaps, such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls. Where appropriate, translates business requirements to functional specifications and technical requirements. Coordinates 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. Prepare project and system related documentation consistent with standards and procedures outlined in the applicable development methodologies. Assist in 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 Facilitate 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 small IT initiatives. Develop Test Plans, Cases, and Scripts and perform and coordinate Testing. Develop and deliver end user training. Other Duties Keep 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: Bachelors Degree in Computer Science, MIS, and Mathematics, Engineering, Business or area of functional responsibility preferred, or equivalent 5 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, prioritizes and meets deadlines in timely manner. 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: Business Inteligence Minimum three years with SAP BW environment and experience with the BI tool set (BO, Xcelsius etc) Preference in SAP BI 7.0. Knowledge in the following SAP functional areas highly desirable; SCM (MM & APO). Ability to travel between multiple sites within the Twin Cities (up to 25% of time). Good level of skills with MS office suite |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-25 20:51:19MinnesotaMNSt. Paul, MN26111012http://jobs.sjm.com/xml/26111012/jobUSAMaple GroveEngineer Principal - R&D Job Requisition #: 11687 Date Posted: 09/27/2011 Category: Engineering Location: Maple Grove - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Position Title: Engineer Principal, R&D For HR Use Only: Reports to Position: Director, R&D Location: Maple Grove Grade: I Division: Cardiovascular FLSA Status: Exempt Organizational Unit: R&D EEO Code: Position Summary: Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of companys strategic plan. Essential Functions: Design of mixed-signal embedded systems Run empirical and experimental analysis. Work with outside consultants, vendors, and the medical community Conceptualize new devices using material knowledge and innovative electrical design. Coordinate the design, procurement, build and debug of new electronic devices Conceive and build prototypes. Project planning. Support animal and bench testing and clinical evaluations. Support design reviews and physician visits. Plan, coordinate, and execute activity in support of project goals Establish requirements and specifications Test method and model development Identify and mitigate project risks Provide technical mentorship to engineers and technicians 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, HALT, HASS and IEC 60601 Technologies: Modeling and simulation experience (SPICE, Matlab, etc.) Excellent lab/bench measurements skills Experience with embedded system integration and support of firmware development (MCU, memory, inter-chip digital interfaces) Thorough understanding of inductive switching regulators and power management High frequency analog and/or RF design experience Experience with EMI design Experience with hybrid (die-on-board) electronics design 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 Accountability/Supervision: Describe the significant problem solving/decision making responsibilities. Describe the extent of supervision received. Relationships: Describe contacts and purpose of relationships. Internal: External: Equipment: List the type of equipment the incumbent in this position is required to work with. Working Conditions: Describe work environment characteristics representative of those encountered by an employee performing the essential functions of the position. Physical Demands: Describe physical demands representative of those that must be met by an employee to successfully perform the essential functions of position. Qualifications: Bachelors degree in Electrical Engineering MS degree in Electrical Engineering preferred 10+ years experience, mainly in R&D engineering Experience designing and testing medical devices required. Experience with a variety of manufacturing processes and designing for manufacturability required. Project leadership and management skills required. Open to or experienced in the latest design tools and techniques (i.e., Six Sigma, Design for Manufacturability, Analytical Design) |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-27 19:27:35MinnesotaMNMaple Grove, MN23871030http://jobs.sjm.com/xml/23871030/jobUSAMaple GroveEngineer Principal - R&D Job Requisition #: 11694 Date Posted: 09/27/2011 Category: Engineering Location: Maple Grove - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Position Title: Engineer Sr, R&D For HR Use Only: Reports to Position: Location: Maple Grove Grade: H Division: Cardiovascular FLSA Status: Exempt Organizational Unit: R&D EEO Code: Position Summary: Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of companys strategic plan. Essential Functions: Run empirical and experimental analysis. Conceptualize new devices using material knowledge and innovative mechanical design. Conceive and build prototypes. Work with outside consultants, vendors, and the medical community. Project planning. Support animal and bench testing and clinical evaluations. Support design reviews and physician visits. Plan, coordinate, and execute activity in support of project goals Establish requirements and specifications, including justification and supportive testing Test method and model development Identify and mitigate project risks 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 delivery systems and implants Bioprosthetic implants Mechanical design of biocompatible metals and plastics Machining Molding Extrusion Thermoforming 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 Accountability/Supervision: Describe the significant problem solving/decision making responsibilities. Describe the extent of supervision received. Relationships: Describe contacts and purpose of relationships. Internal: External: Equipment: List the type of equipment the incumbent in this position is required to work with. Working Conditions: Describe work environment characteristics representative of those encountered by an employee performing the essential functions of the position. Physical Demands: Describe physical demands representative of those that must be met by an employee to successfully perform the essential functions of position. Qualifications: Bachelors degree in Mechanical Engineering MS degree in Mechanical Engineering preferred 5-10 years experience Experience designing and testing medical devices required, preferably interventional cardiology devices. Experience with a variety of manufacturing processes and designing for manufacturability required. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-27 19:27:46MinnesotaMNMaple Grove, MN23871109http://jobs.sjm.com/xml/23871109/jobUSASt. PaulSenior Paralegal Job Requisition #: 12258 Date Posted: 01/16/2012 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 in St. Paul: Job Overview The Senior Paralegal position is responsible for providing high quality legal support for the Cardiovascular Division with an emphasis on clinical and contracts areas. Responsibilities: Assists division Counsel and the division clinical department with general and clinical contract drafting, negotiation and review Provides legal support and liaison between departments and divisions to execute the companys business and clinical trial objectives Supports company contracting process, including conducting assessments drafting and reviewing procedures, evaluating and maintaining electronic platforms and databases, training employees, acting as custodian of associated documents in accordance with document retention policies Provides electronic and documentary research, file management, and administration related to general legal matters Prepares and reviews legal documents, such as memoranda, affidavits, corporate records, agreements, pleadings and government filings Maintains and updates docketing database to track deadlines associated with contracts and other legal obligations Assists factual investigations, including interviews, internet sources, and document reviews related to legal and compliance matters Assists in data collection and reviews of payments to or on behalf of Health Care Professionals in clinical trials for fulfillment of reporting obligations Requirements: Bachelor's degree Five years of related experience General knowledge and experience in negotiation and drafting of contracts Excellent organizational and records management skills Strong prioritization, problem-solving and time management skills Ability to coordinate and manage the completion of multiple time-sensitive projects simultaneously Excellent oral and written communications skills Ability to constructively interact and coordinate with diverse personalities to accomplish assigned tasks Ability to analyze, evaluate and synthesize data from multiple sources Preferred Qualifications: Paralegal certificate Experience in medical device, pharmaceutical, health sciences or health care industry Experience with Computer Packages Inc (CPI) docketing software or comparable software preferred |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-16 20:53:15MinnesotaMNSt. Paul, MN25914643http://jobs.sjm.com/xml/25914643/jobUSAMinnetonkaSoftware Release Coordinator Job Requisition #: Corp 11048 Date Posted: 06/20/2011 Category: Information Technology Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview The Release Cutover Analyst is responsible for the effective execution of cutover activities within the program for new SAP implementations and projects. Responsibilities include coordination and managing the SAP cutover plan which encompasses activities necessary to transition users from their legacy system on to SAP. The Release Cutover Analyst is responsible for all documentation related to planning, preparing and executing the SAP cutover project plan ensuring successful timings and execution of all master data conversions, transport migrations and assisting with legacy shut down processes for the various business units. Job Duties: Lead cutover activities with consistent direction and project focus as directed by the Project Management Office (PMO) and GCC Release Management. Act as an integrating mechanism to ensure release activities adhere to SAP GCC process in terms of Ascendant documentation, change control, cutover, release management, and validation. Responsible for detailed project management of the cutover and conversion deliverables in all environments, resolving discrepancies or process issues related to cutover. Responsible for ensuring successful planning and execution of integrated Release cutover activities and associated SAP outages. Responsible for creating and maintaining the Cutover Project Plan as per the GCC Cutover Standards. Monitor and manage team progress to meet cutover milestones; schedules and facilitates cutover status meetings. Track and report cutover status including identifying, categorizing and escalating cutover issues that require management attention. Ensures effective communication channels exist between divisional and functional team resources regarding Release cutover activities. Act as an integrating mechanism to ensure cutover activities are in sync with GCC and EIT processes and groups; EIT Enterprise Command Center, Interface Partners, other projects, change control, release management, validation, testing and production support. Serve as the Integration SME for other project managers and groups involved in releases. Involved in coordination of legacy shut down activities for each business unit. Liaison with the Production Support team in determining outage and Hypercare transition. Responsible for coordinating various SAP outages; identifying integration points and working closely to communicate and engage IT and business partners as needed. Lead cutover activities for Pre Go-Live, Go-Live weekends and Post Go-Live. Partner with Production Support and EID BW groups to obtain business approval on outage timings. Manages inter/intra-team relationships within the program and fosters/maintains positive working relations and collaboration within the team for preparation of implementation. Operates without appreciable direction within the scope of the project and related cutover activities. Maintains good relationships with managers and directors; staying informed on the goals, objectives and overall business requirements of the SAP program. Responsible for maintaining the Cutover Competency Guide. Serve as backup resource for overall SAP Release Management activities. Qualifications: Bachelors degree Business, Computer Science or a related field. 5+ years progressively more responsibility in the areas of operations or technology. 2+ years directly managing ERP implementations or involved in management of key activities, preferably SAP. Well developed planning, organizational, and problem-solving skills. Must be accomplished in managing very detailed project plans. Exhibit the ability to work effectively across the team and to build positive working relationships. Possess strong analytical and problem-solving skills. Highly developed business acumen with working knowledge/understanding of business processes as they relate to cutover activities. Proven project management experience with the ability to troubleshoot issues, manage timelines/deadlines and foresee opportunities to improve and harmonize business processes across the project team and initiate appropriate action. Possess strong analytical and problem-solving skills. Exhibit the ability to work effectively across the team and to build positive working relationships based on mutual respect. Highly organized, capable of multi-tasking and capable of coordinating/aligning resources under an integrated project plan. Ability to work independently to successfully complete projects against the defined timelines/milestones and budget. Experience with managing aspects of SAP projects and SAP Change control mechanisms a plus. SAP Functional and Technical knowledge preferred. Excellent verbal and written communication skills with the ability to influence within and across organizations, functions and business areas. Able to present and defend design decisions across business units. Ability to travel domestically and internationally, up to 25%. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-06-20 19:32:52MinnesotaMNMinnetonka, MN21915684http://jobs.sjm.com/xml/21915684/jobUSAMinnetonkaSr. SAP Manufacturing Business Analyst Job Requisition #: Corp 12001 Date Posted: 01/12/2012 Category: Information Technology Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at one of our Minnetonka, MN locations. Job Overview Leads projects to implement changes on behalf of the business. Analyzes business and technical processes, documents business requirements, defines changes to business processes and assists in modifying them, configures, tests and implements enterprise-wide business systems. Interviews business partners to define detailed business requirements. Maps current processes to the desired state and identifies gaps, such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls. Where appropriate, translates business requirements to functional specifications and technical requirements. Serves as the primary point of coordination and communication for a business domain to the business process owner. Coordinates 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. 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. Proactively identify areas for continuous improvement(CI) measures to reduce overall support requirements; implement CI measures within the L2 team. 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. Leads 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. Assists as requested in refining and updating existing service level agreements and specifications to ensure they reflect the needs of the broader SAP user base. Participates in the execution of post release Hypercare operations. Executes and measures Level 2 Operations team performance against a defined set of performance metrics. 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. Provides management reporting for team goals, timelines and status. Acts 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 Bachelors 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. 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. Technical Qualifications: Vast understanding of Planning and/or Manufacturing processes in an ERP* system. 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. Minimum of five years experience in a lead role deploying ERP* Operations Functionality within Demand Planning and / or APO and / or Production Planning and / or Manufacturing and / or Procurement. 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. * ERP preferred system is SAP |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-12 18:50:22MinnesotaMNMinnetonka, MN25857855http://jobs.sjm.com/xml/25857855/jobUSASt. PaulIntellectual Property Attorney II Job Requisition #: AF13660 Date Posted: 01/19/2012 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. - 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. - 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: - Masters degree in science or engineering. - Applied legal experience in the medical devices, biomedical, pharmaceutical or related industries. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 18:29:30MinnesotaMNSt. Paul, MN25984914http://jobs.sjm.com/xml/25984914/jobUSAPlymouthDirector - Clinical Job Requisition #: 12188 Date Posted: 01/18/2012 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 Position Summary: Oversees, designs, plans and develops clinical projects to support the Cardiovascular Division business objectives. Prepares protocols and conducts clinical studies that have been determined to satisfy a medical need and/or offer a commercial potential. Serves as a medical/scientific consultant to marketing and functions within the Product Division. Monitors and/or interprets results of clinical investigations in preparation for device applications. Essential Functions: Accomplishes results through delegation of responsibility to subordinate management levels Determines and establishes organizational structure and supervisory relationship, subject to approval by Sr. Clinical Director Provides leadership, coaching, and career development Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, and ethical behavior Design, implement and maintain Clinical Studies so that the rights of the subjects are protected and that internal and external personnel involved in each study are trained and compliant to regulations They will ensure that the clinical research department is aligned with the business objectives. Essential Requirements: Bachelor's degree in health sciences, biostatistics, or biological sciences Minimum 10 years experience in clinical research for medical device or pharmaceutical company Minimum 10 years progressive leadership experience in functional area A solid knowledge of clinical biostatistics and applicable clinical trial regulations both US and OUS is required for this position. Demonstrated leadership skills in the achievement of company goals and objectives Must possess strong oral and written communication skills Good interpersonal skills Skillful in formulating strategies, tactics, and action plans to achieve results Ability to work in a fast paced environment Must be adept at working across cross-functional teams Ability to work well under pressure and maintain positive, enthusiastic attitude Able to travel 25% on average Preferred Requirements: Master's degree preferred Preferred experience in cardiovascular therapeutic area for both pre-market and post-market approval clinical trials |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 08:11:56MinnesotaMNPlymouth, MN25977264http://jobs.sjm.com/xml/25977264/jobUSAMinnetonkaSoftware Engineering Intern Job Requisition #: 12193 Date Posted: 01/18/2012 Category: Internship 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 Position Summary: This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Essential Functions: 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. Evaluate Software and assess Part 11 audits. Qualifications: Current student working towards a degree in Engineering or Technical Field (Mechanical, Manufacturing or Software degree preferred) Must be enrolled in the 2012 fall semester Software Quality Engineering lab experience Exposure to FDA regulatory, GMP, IEEE 1012 and ISO 13485 Solid communication and interpersonal skills Computer skills Experience in statistical/data analysis and report writing skills Information Technology and data mining skills Assignment: Summer Internship Please Note: No housing, transportation, or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 08:11:30MinnesotaMNMinnetonka, MN25977256http://jobs.sjm.com/xml/25977256/jobUSASt. PaulSoftware Engineering Intern Job Requisition #: 12194 Date Posted: 01/18/2012 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 in our Cardiovascular Division: Job Overview Position Summary: This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Essential Functions: 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. Evaluate Software and assess Part 11 audits. Qualifications: Current student working towards a degree in Engineering or Technical Field (Mechanical, Manufacturing or Software degree preferred) Must be enrolled in the 2012 fall semester Software Quality Engineering lab experience Exposure to FDA regulatory, GMP, IEEE 1012 and ISO 13485 Solid communication and interpersonal skills Computer skills Experience in statistical/data analysis and report writing skills Information Technology and data mining skills Assignment: Summer Internship Please Note: No housing, transportation, or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 08:11:29MinnesotaMNSt. Paul, MN25977254http://jobs.sjm.com/xml/25977254/jobUSAPlymouthIntern - Health Economics & Reimbursement Job Requisition #: 12253 Date Posted: 01/19/2012 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 our Cardiovascular Division: Job Overview Position Summary: The need to deliver compelling economic value messages about St. Jude's Cardiovascular Division (CVD) product to hospital and physician customers has become increasingly evident. As such, the CVD function is tasked with the development of economic tools and strategies for key CVD growth drivers in various geographies. The intern will support the development of this new organization and will be expected to impact on patient care and the CVD business. Duties and Responsibilities: Develop economic value programs for selected CVD technologies. Conduct literature reviews Develop economic models and selling tools Identify the unique economic needs of CVD's customers in collaboration with other CVD and St. Jude personnel Develop broad knowledge of CVD's business and technologies. Develop good working relationships with key opinion leaders across SJM and in the medical technology industry Provide analytical support, including economic analysis and value message development, to clinical research, sales, marketing and management on health economics. Conduct reimbursement and health economic assessments for selected CVD technologies Qualifications: Four year degree required; finance or economics degree preferred. Current student enrolled in accredited MBA program or PharmD program required. Must be enrolled in fall semester of 2012 Experience in reviewing peer-reviewed medical literature and developing economic models required. Experience in health economics and reimbursement strongly preferred. Minimum of four years of consulting, marketing, finance or business development experience preferred. 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 have excellent interpersonal skills and strong strategic management skills. 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: Summer Internship Please Note: No housing, transportation, or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 18:30:21MinnesotaMNPlymouth, MN25984948http://jobs.sjm.com/xml/25984948/jobUSASt. PaulPrincipal APD Engineer Job Requisition #: AF13716 Date Posted: 01/19/2012 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 We are seeking a talented, results-oriented Principle Engineer to join our Advanced Process Development group. 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 a Principle Engineer, the individual will execute activities on key projects and participate in the design and development of automated test systems. Impacts this role will have: Uses test system development knowledge in designing and developing test systems primarily using LabView and National Instruments hardware. Develop Test System Specification and requirements. Uses multidisciplinary engineering knowledge to participate in the manufacture and development of innovative medical devices or components/subsystems in support of companys strategic plan. Conducts process development work as part of a major project. Oversees and performs analyses to develop process specifications. Provides technical information concerning manufacturing techniques, components, and test algorithms. Mentors others in LabView and Test System Development principles and activities. The Senior Engineer may work on process design and development for Cardiac Mapping Systems, Recording Systems or Therapy Systems. Work with R&D, Quality, Manufacturing and external suppliers to understand test needs. Test Systems Verification and Validation activities. Qualifications: Bachelors Degree in electrical engineering or related field, advanced degree preferred 9+ years experience in test systems development for electrical systems. Experience with development of medical devices preferred. Experience with a variety of test systems including test systems for Large/Capital systems, High Voltage testing preferred. To learn more or to apply, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 18:30:19MinnesotaMNSt. Paul, MN25984947http://jobs.sjm.com/xml/25984947/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: AF13725 Date Posted: 01/18/2012 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, 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 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). 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. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-19 08:11:15MinnesotaMNMinnetonka, MN25977239http://jobs.sjm.com/xml/25977239/jobUSAMinnetonkaGroup Leader I - 2nd Shift Job Requisition #: AF13768 Date Posted: 02/07/2012 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 at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Group Leader for our Minnetonka location. The successful candidate will be responsible for assisting the Supervisor in all daily activities on the production lines. This is a 2nd shift position. Impacts this role will have: • Assembly of product per detailed process including R&D and miscellaneous testing. • Provide administrative support to production area including monitoring and scheduling work, monitoring inventory and demonstrating a working understanding and support of the MRP inventory system. • Notify production supervisor or engineering of discrepancies with the product process, tools, and/or equipment. Participate in problem solving through root cause analysis of defects for non-conforming product and area specific problem solving. • Train and mentor assemblers. • Maintain traceability through device history record and complete production inspection procedures. • Participate in the development or improvement of process work instructions through the approved documentation system. • Other duties as assigned, such as assisting the Supervisor with employee screening, development, discipline, and performance appraisals. Qualifications: • High school diploma or equivalent. • 2+ years experience in medical device assembly. • Must be detail-oriented, self motivated, and have ability to handle multiple tasks. • Must be able to work within close tolerances and have manual finger and hand dexterity. • Ability to read and understand detailed processes essential. • Must demonstrate knowledge of Lean manufacturing and various types of inventory control methods and computer skills. • Proven ability to work well with others. • Previous lead experience in a manufacturing environment desired. • Must be able and willing to work overtime. Preferred Qualifications: • BA/BS. • Medical device manufacturing experience. To learn more or to apply, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-08 07:38:25MinnesotaMNMinnetonka, MN26394627http://jobs.sjm.com/xml/26394627/jobUSAPlymouthClinical Research Coordinator Job Requisition #: 12412 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 Coordinator II will implement functions of clinical research. Works under direct supervision. Develops alternatives solutions for problems of limited scope and complexity. Responsibilities: Creates and manages study files, regulatory binders, agreements, site approvals, etc Assist with study material tracking and accountability First and second pass data entry Initiate clinical investigations by arranging proctoring and staff training In-house case report form auditing and data verification Assist with reports the FDA Work independently on specific study projects Assist CRA in setting up sites (IRB approvals, Investigator agreements, and study start up) Assist with monitoring visits by assuring protocol compliance per applicable regulations 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 Participate in professional activities outside of normal business hours Other duties as requested Requirements: BA/BS in Science or Nursing 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.United StatesSt Jude Medical2012-02-08 07:38:58MinnesotaMNPlymouth, MN26394662http://jobs.sjm.com/xml/26394662/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.United StatesSt Jude Medical2012-02-08 07:39:11MinnesotaMNPlymouth, MN26394667http://jobs.sjm.com/xml/26394667/jobUSASt. PaulSupv, Customer Service Job Requisition #: USD 9061 Date Posted: 03/06/2011 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 The position leads a team of Customer Service Representatives within the USD Division of St. Jude. The position requires the supervisor to train, motivate and coach employees to continuously improve the quality and productivity of department output and introduce innovative methods to support this effort. Requirements/Education: High School diploma required; College degree preferred. 4-6 years of Customer Service call center experience. 2+ years of Supervisory experience required. Demonstrated ability to train and mentor others required Medical Device Industry experience preferred |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-05-18 23:42:04MinnesotaMNSt. Paul, MN21348932http://jobs.sjm.com/xml/21348932/jobUSASt. PaulSr. System Administrator - UNIX Job Requisition #: Corp 12015 Date Posted: 02/09/2012 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 The Sr. Unix Systems Admin position provides enterprise support for server and data center administration. This position will be the technical authority on incident management and responsible for determining business risk. Essential Functions: • Oversees installation, configuration and maintenance of existing computing server environments and platforms. • Monitors and acts to ensure: user access, security and data integrity for specified servers; the absence of negative business interruptions relative to server uptime performance; user acceptable response times; and the identification of server related problems. • Participates as a member of a corporate-wide server administration team to ensure consistency in the application of management and administrative policies and procedures relative to computer servers. • Working closely with members of upper management, drafts proposals or papers, acts as a vendor liaison, conducts presentations to customer or client audiences and/or professional peers. • Assist in evaluating new requirements and recommend new processes and standards and appropriate. • Mentors less experienced system administrators in the performance of day-to-day and project-related duties as directed. • Troubleshoots and solves problems with existing systems quickly and completely. Responsible for diagnosing the problem, impact analysis and implementing a solution to prevent future problems. • Assist in defining standards, guidelines, best practices and metrics. • Provide 24x7 on-call support as part of rotating team coverage. Other Duties: • Participates, as requested, in the Information Technology strategic planning process. • Designs/implements complex local and wide-area networks of machines. • Develops and executes function and performance tests. • Performs related functions and responsibilities, on occasion, as assigned or required. Qualifications Required: • 8+ years of technical experience in Sun Solaris/HP-UX/Linux based operating systems administration in a medium to large completer server environment. • In-depth knowledge and application of advanced concepts and practices in knowledge of and experience with paging and swapping, inter-process communication, devices and what device drivers do, file system concepts ("inode", "superblock"), can use performance analysis to tune systems. • A demonstrated understanding of networking/distributed computing environment concepts; knowledge of and experience with principles of routing, client/server programming, the design of consistent network-wide file system layouts. • Ability to program in an administrative language (Tk, Perl, a shell, DCL). • Able to travel between multiple sites within the Twin Cities (up to 25% of time). • Good consultative and communication skills. • Ability to work effectively within a team and as an individual contributor. • Ability to effectively work in a fast paced changing environment. Qualifications Desired: • A relevant advanced degree and/or appropriate professional certification. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-09 23:07:20MinnesotaMNSt. Paul, MN26442357http://jobs.sjm.com/xml/26442357/jobUSASt. PaulTechnology Program Mgr II (R&D) Job Requisition #: AF13670 Date Posted: 02/09/2012 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, Technology Program Manager. The successful candidate will be responsible for managing the Atrial Fibrillation technology portfolio and identifying new technology opportunities. This position will work cross-functionally with Marketing, Engineering and Research groups across sites. Impact this role will have within the AF division: • Manage technology portfolio driven by both the AFD 5-year product roadmap and identified new technology opportunities. • Guide new technologies from inception to product integration readiness. • Manage technology intercept strategy. • Works with Marketing, Engineering and Research groups across sites to define and manage technology development efforts. • Defines and executes technology development plans. • Provides initial product definition (Charter) • Defines top-level system requirements and architecture. • Transition technology development efforts to development teams for program execution. • Work with appropriate functions to define Regulatory, Quality, and Clinical assumptions and plans for technology development projects. • Collaborate with Advanced Process Development and Operations in the creation of top-level design for Manufacturability requirements. • Define new technology claims with input from Marketing. • Identify/evaluate new technology and product proposals. • Focal point for R&D organization in the portfolio management process. Required Qualifications: • BA or BS with a major in math, engineering, life sciences, business, or other relevant degree required. • 5-7+ 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. • 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. • Prior experience managing others preferred. • Successful experience in the development of class II and class III medical devices. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-09 23:08:02MinnesotaMNSt. Paul, MN26442376http://jobs.sjm.com/xml/26442376/jobUSAPlymouthTechnician - R&D Job Requisition #: 12190 Date Posted: 01/30/2012 Category: Technician 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 position will be to support all lab activities associated with the development of braided nitinol devices and delivery systems. Duties and Responsibilities: Perform equipment validations and preventive maintenance on R&D equipment. Work with quality to maintain calibrations on measurement equipment. Maintain raw material inventories and order consumables for R&D area. Cleaning and organization of R&D spaces (Lean Efforts) Logging of hazardous waste. Conducting testing Assist in the design, build, and assembly of fixtures Identify and establish relationships with key suppliers for R&D and production components. Other duties as assigned. Physical Requirements: Frequent use of computer keyboard and monitor. Frequent standing or sitting for long periods of time. Occasional use of microscope. Occasional lifting up to 10 pounds. Education, Experience, Personal and Technical Skills: High school diploma or equivalent minimum and 2yr Technical degree preferred |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-30 22:06:17MinnesotaMNPlymouth, MN26198166http://jobs.sjm.com/xml/26198166/jobUSAPlymouthIntern - Biostatistician Job Requisition #: 12273 Date Posted: 01/30/2012 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 our Cardiovascular Division: Job Overview Position Summary: This Biostatistics intern is within Clinical Department of CVD, SJM. This intern will report to Biostatistics Supervisor and provide statistical support to the Biostatistics Supervisor and the Clinical group on the clinical studies. The primary responsibility will include statistical programming, validation, analysis or simulation for specified studies or project-type assignments. Duties and Responsibilities: Write the SAS or other statistical programs; clean and manipulate data; create/validate analysis datasets and statistical tables/summaries; explore the statistical analysis methods and application; perform simulation; interpret the analysis results obtained and determine if the data/assumption is valid; create SAS macros and other study tools as necessary; help with the other tasks assigned Qualifications: - Current student pursuing M.S. or Ph.D. Degree in Statistics or Biostatistics or relevant, having completed at least one year of graduate study. - Must be enrolled in the 2012 fall semester - Experience with data manipulation, statistical analysis and graphing with a common statistical software package such as SAS, S-Plus or R. Strong programming skill in computing packages, mathematical calculations, data simulation, and Bayesian analysis are a plus. - Familiarity with basics and statistical methods that apply to clinical trials. - Some experience or schooling in Computer Science - Good oral and written communication skills, ability to work in a team environment - Excellent attention and accuracy with details - Familiarity with Microsoft Office suite (e.g., Word, Excel, Power Point). Assignment: Summer Internship Please Note: No housing, transportation or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-30 22:04:26MinnesotaMNPlymouth, MN26198113http://jobs.sjm.com/xml/26198113/jobUSASt. PaulSupervisor - Manufacturing Job Requisition #: 12331 Date Posted: 01/30/2012 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 This 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. 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. Qualifications: 5 -7 years of solid supervisory experience in a manufacturing operation. Requires high school diploma or equivalent, bachelors 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 Experience working with new product development preferred. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-30 22:04:14MinnesotaMNSt. Paul, MN26198105http://jobs.sjm.com/xml/26198105/jobUSASt. PaulAttorney, Intellectual Property Job Requisition #: 11564 Date Posted: 09/07/2011 Category: Legal Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Assist the Chief Intellectual Property Attorney for the CVD division with creating and managing domestic and international intellectual property portfolios. Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. Essential Functions: 1. (a) Collect, screen and manage invention disclosures; (b) conduct meetings with inventors and management teams to review invention disclosures; and (c) prepare and prosecute patent applications. 2. Participate in due diligence initiatives as they relate to intellectual property. Analyze competitors portfolios. Assist with patent clearance activities for new products/services and formulate non-infringement and invalidity positions as necessary. 3. Assist in managing outside patent and trademark counsel, including the assignment of matters, oversight of work, and the review of invoices. Assist outside litigation counsel with intellectual property litigation. 4. 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 or intellectual property assets. Help develop electronic and hardcopy training materials and give presentations on substantive legal areas related to intellectual property. 5. Draft and negotiate technology agreements, including, for example, research and development agreements, confidentiality agreements, license agreements and consulting agreements. Qualifications: JD from accredited law school-admitted to practice law in the state where office is located (i.e. Minnesota) or eligible for admission. USPTO registration. 3 - 5+ years of experience prosecuting mechanical and/or electro-mechanical patent applications with a law firm and/or large corporation. Experience counseling clients with their patent, trademark and copyright issues. Strong academic credentials, excellent analytical, communication and organizational skills. Ability to weigh legal risks against business factors; ability to deliver proactive and innovative legal advice in a fast-moving, team oriented environment. Ability to multi-task and work under deadlines. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-07 18:51:33MinnesotaMNSt. Paul, MN23465478http://jobs.sjm.com/xml/23465478/jobUSASt. PaulIntern - Regulatory Affairs Job Requisition #: 12225 Date Posted: 01/17/2012 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 in our Cardiovascular Division: Job Overview Position Summary: This position is responsible for supporting the Regulatory Affairs department in the area of global product registration to ensure timely marketing approvals. Duties and Responsibilities: Assist in supporting/preparing global regulatory submissions to secure/maintain marketing approvals Assist in updating STEDs for global submissions Assist with electronic filing RA records/submissions Assist with maintaining databases to support international regulatory affairs Qualifications: Current student, in Jr. or Sr. year, pursuing a BA, BS or MS in a technical discipline or Regulatory Affairs Must be enrolled in Fall Semester of 2012 Some experience with medical device industry preferred Some cursory knowledge of medical device regulations preferred Microsoft Access, Microsoft Sharepoint working knowledge desired Assignment: Summer Internship Please Note: No housing, transportation or relocation allowance provided. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-17 21:18:57MinnesotaMNSt. Paul, MN25941991http://jobs.sjm.com/xml/25941991/jobUSASt. PaulSenior Technical Writer Job Requisition #: AF13654 Date Posted: 11/07/2011 Category: Quality Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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 Technical Writer to develop and maintain guidelines, formats and standards for Instructions for Use (IFUs) or Physicians Manuals within AFD. This Senior Technical Writer will also coordinate the translation of released documentation and labeling through approved translation vendors. This Writer will create and lead others to develop IFUs within the established guidelines to create and maintain an AFD and SJM consistent product and a world-wide compliant labeling product. Impact this role will have: Develops an IFU strategy with guidelines consistent with worldwide regulatory requirements, while following AFD/SJM branding and web publishing guidelines. Delivers IFUs that are developed guidelines and provides relevance and ease of use for the customers. Works with project teams to plan, create, and complete customer technical user manuals within project goals. Leads and develops IFUs within the guidelines and translates technical details into organized and easily understood information. Evaluates, maintains and works with translation and graphics suppliers to provide cost effective solutions for translations and layouts of IFUs. Interfaces with SJM reviewers to obtain translated text and associated translation review certificate. Required Qualifications Bachelors degree. Medical device industry experience. Polished communicator- written documentation and oral presentations/ discussions/ meetings. Excellent reputation for building cross-functional relationships. Organized, on-time, and detailed project management skills. Energized attitude. Proven track record for delivering consistent, effective technical communication. Desktop publishing experience in Adobe InDesign and Framemaker. Effective organizational skills, ability to coordinate multiple tasks, manage priorities and yet exhibit provide critical detail orientation. Experience in a FDA and ISO quality system environment. Preferred Qualifications: Completed coursework focused on Technical Writing. Web Desktop publishing experience. SAP. Windchill. Documentation control with sound revision control processes in a FDA and ISO quality system environment. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-07 18:32:31MinnesotaMNSt. Paul, MN24726786http://jobs.sjm.com/xml/24726786/jobUSASt. PaulEngineer - Quality Job Requisition #: 12059 Date Posted: 12/16/2011 Category: Engineering Quality Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul. 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 technical experience Previous Quality experience and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner Advanced computer skills, including gap analysis and report writing skills Prior medical device experience preferred Six Sigma certification preferred SQ CQE, CQA certification preferred |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-12-16 21:24:43MinnesotaMNSt. Paul, MN25426648http://jobs.sjm.com/xml/25426648/jobUSASt. PaulProduct Manager, ICD & ICD Leads Job Requisition #: ID11728 Date Posted: 11/22/2011 Category: Finance Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our International Sales Division located in St. Paul, MN: Job Overview St. Jude Medical, Inc. in St. Paul, MN seeks an International Product Manager, ICSs and ICD Leads to provide product marketing leadership and strategy for ICDs (Implantable Cardiac Defibrillators) and ICD Leads sold internationally. Act as a key interface between international customers, geographic sales team and Product Division. Develop specific marketing plans and activities for specific products to establish, enhance, or distinguish product placement. Develop business plans and product positioning in international market place. 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. Requires a U.S. Master of Business Administration Degree plus two years of experience as a marketing and/or sales manager at a multi-national medical device company, marketing and selling medical devices including cardiac therapies and products to hospitals in international markets. All experience may be gained concurrently. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-22 19:36:45MinnesotaMNSt. Paul, MN25004143http://jobs.sjm.com/xml/25004143/jobUSASt. PaulScientist - R&D Job Requisition #: 11710 Date Posted: 09/30/2011 Category: Research Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division: Job Overview Duties and Responsibilitites: The successful candidate will serve as a Subject Matter Expert (SEM) 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 interdisciplinary area of materials properties, failure analysis, effects of processing on materials, test method selection, development and validation. Candidate must have strong ability to apply knowledge of materials science and 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. Individual must be able to identify unique material challenges associated with material interactions. Train and direct other members of the staff. Analyze, interpret and draw conclusions from materials evaluation. Remain current with technology and testing standards. Education and/or Experience: Expertise in materials science or engineering with focus on biomedical materials 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: -Extensive background in Biomaterials (such as Nitinol, stainless steel, titanium, carbon, polyurethanes, silicone and others ) and their interactions with biological systems - Knowledge of hemocompatibility, biocompatibility and toxicology assessment - Extensive 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. - Knowledge of industry standards for biomaterials characterization - Knowlage in corrosion science Experience in RF ablation and/or in electrode stimulation devices is prefered 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 2-4 years MS with 3-6 years BS with 5-8 years of relevant product development expertis |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-30 22:01:12MinnesotaMNSt. Paul, MN23953886http://jobs.sjm.com/xml/23953886/jobUSASt. PaulResearch Engineer Job Requisition #: AF13616 Date Posted: 09/30/2011 Category: Research Engineering Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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, 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. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-09-30 22:01:15MinnesotaMNSt. Paul, MN23953890http://jobs.sjm.com/xml/23953890/jobUSASt. PaulMarketing Manager II Job Requisition #: AF13612 Date Posted: 09/19/2011 Category: Marketing Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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.United StatesSt Jude Medical2011-09-19 19:38:36MinnesotaMNSt. Paul, MN23703439http://jobs.sjm.com/xml/23703439/jobUSASt. PaulRegulatory Affairs Specialist II Job Requisition #: 12040 Date Posted: 01/06/2012 Category: Regulatory Affairs Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul. Job Overview The Regulatory Affairs Specialist II position will develop and implement regulatory strategies in collaboration with regulatory and product development staff. This position will focus primarily in the Asia Pacific region. Responsibilities: Manage International Regulatory submission in the Asia Pacific region and other regions as needed Develop and maintain effective working relationships with in-country offices & regulatory agencies in countries where Cardiovascular Division products are marketed Actively participate in medical device industry working groups as a representative of St. Jude Medical s Cardiovascular Division Negotiate directly with agencies on complex submission issues Acquire and maintain current knowledge of applicable regulatory requirements and scientific or technical issues Evaluate proposed manufacturing/product changes on regulatory submission strategies and existing licenses, and determine the level of change and consequent submission requirement for assigned markets Qualifications: BS/BA in a technical discipline required 3+ years experience in the medical device industry Chinese language proficiency desired International Regulatory Affairs experience desired |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-06 19:27:04MinnesotaMNSt. Paul, MN25740055http://jobs.sjm.com/xml/25740055/jobUSASt. PaulField Clinical Evaluations Sr. Manager Job Requisition #: USD 9392 Date Posted: 01/04/2012 Category: Clinical Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position available in our US Sales Division. Job Overview Acting independently and within broad policy, has primary management responsibility for Field Clinical Engineering (FCE) activities related to the function of sales support through clinical evaluation and demonstration. Provides applications training and technical support to Health Care Professionals (HCPs) and St. Jude Medical sales personnel. Interfaces with services and sales management to efficiently administer account development requirements. 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. Identifies and routinely uses the most effective, cost efficient business practices to execute processes. Remains current on developments in field(s) of expertise. Requirements/Education: A Bachelors Degree in Engineering, Biological Sciences, a related field or equivalent; typically ten plus years of progressively more responsible clinical experience in cardiology, electro-physiology, or working with Implantable Cardiac Defibrillators (ICDs), pacemakers, or cardiac electro-physiology procedures. A minimum of four plus years of demonstrated experience at a supervisory/managerial level is typical. Requires highly developed leadership skills/people-management experience sufficient to assume the complex range of personnel issues inherent in this position, 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 adept at delegation, follow-up, and team building. The ability to work cooperatively/productively with others is also needed. The ability to change the thinking of, or gain acceptance of, others in sensitive situations is also necessary. Comprehensive verbal and written analytical/problem solving, communication, negotiation, interpersonal, training and presentation skills are essential. Documented record of delivering Field Clinical Engineering information that 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. Proficient personal computer skills including spreadsheet skills, word processing, data base management, and other relevant applications. Desired Requirements: An advanced credential in a relevant discipline/concentration (i.e. MS degree in engineering/science). Professional Health Science certification or designation. 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.United StatesSt Jude Medical2012-01-04 18:48:35MinnesotaMNSt. Paul, MN25690424http://jobs.sjm.com/xml/25690424/jobUSASt. PaulSr. Telephony Engineer Job Requisition #: Corp 11105 Date Posted: 11/08/2011 Category: Information Technology Location: St. Paul - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Corporate Headquarters in St. Paul. Job Overview 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 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. Leads 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 maintain 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. 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: BS degree in computer science, engineering or telecommunications and/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 20%. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-11-08 20:40:52MinnesotaMNSt. Paul, MN24757501http://jobs.sjm.com/xml/24757501/jobUSAMinnetonkaSAP Basis Administrator Job Requisition #: Corp 12005 Date Posted: 01/10/2012 Category: Information Technology Administrative Location: Minnetonka - MN - USA About Us St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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 is responsible for performing BASIS functions that include, but are not limited to: application support; performance monitoring and tuning; assisting with planning; designing, managing, and implementing SAP within a defined landscape; and adhering to the current BASIS policies and best practices with process development and documentation. Job Duties: Work closely with team leaders to understand current project and support priorities and provide support for day to day deliverables as prioritized and requested by management. Develop, maintain, and continually improve documentation for SAP Basis Policies and Procedures. Attend regular Change Control Board meetings to represent the SAP Basis team. Planning for SAP Installations, System Sizing (Capacity planning), Disk / Storage / Server Layout, and System Installation Plan. SAP Software Installation and Support: Installation of SAP Components based on SAP WAS 6.xx & 7.xx, SAP Solution Manager 7, SAP Business Warehouse 7, SAP CRM 5.0, SAP SCM 5.1 (including APO), SAP ECC 5.0 and SAP Enterprise Portals 7.0 GTS 7.2. Post Installation Setup of SAP Components: Initial System Backup, Configure SAPs Transport Management System, Request / Set-up SAP Developer Keys, Setup SAPROUTER connection to SAP, Install support packages, Client Copy, Install OSS notes, Configure SAP Note Assistant, SAP DBA configuration, Tuning / Modification of SAP and instance parameter files, Configuration of the SAPLOGON entries for the newly installed system, and setup of printers. Daily System Monitoring: Execution of all System Administration Assistant activities and troubleshoot / resolve problems reported by project teams. Particiapte in on-call rotations. Qualifications: Bachelor's degree in Business, Management of Information Systems, Computer Science or related field or equivalent 6 years work experience. 4+ years experience as a SAP Basis administrator providing support and guidance to SAP Basis team or large contribution to several SAP Basis projects. 3+ years in a SAP production support environment or multiple full life cycle projects. SAP Certification on UNIX platform a plus. Strong time management skills. Highly self-motivated and directed. Strong project management skills with excellent attention to detail. Experience working in a team oriented, collaborative environment. Ability to learn new technologies with minimal training or supervision. Experience with SAP applications operating system administration (Unix and Windows). Strong troubleshooting, analytical, problem-solving, conceptual and performance tuning skills. Strong customer focus and management of client expectations. Work with minimum supervision. Excellent communication (written/documentation and verbal) and interpersonal skills. Ability to travel up to 10%. Ability to take on complex projects and assignments without detailed specifications and provide leadership direction to other SAP Basis personnel as appropriate. Should be willing to work on a 24x7x365 support environment. Experience in working in a SOX regulated environment. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-10 20:57:05MinnesotaMNMinnetonka, MN25811130http://jobs.sjm.com/xml/25811130/jobUSAMinnetonkaManager - Supply Chain Job Requisition #: 12280 Date Posted: 01/23/2012 Category: Manufacturing Logistics 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: This position is accountable for the overall supply chain leadership and management of planning, sourcing, buying, inventory management, and logistics processes for an assigned product family or value stream. As a problem solver and key process leader, this role is responsible for setting and executing global supply chain planning and purchasing strategies for assigned goods and services required for their product family or value stream. In conjunction with these defined operational supply chain expectations, this position will also directly contribute to overcoming supplier technical issues, managing supplier requested changes for existing components, and processes improvements where suppliers or supply items are involved. This position may supervise planning, buying, and component engineering resources that will be responsible for leading and coordinating cross-functional sourcing projects, defining supplier process improvement actions, facilitating internal process development activities impacting suppliers, and coordinating product/process validations with other cross-functional technical teams. Key deliverables for this position are leading and managing supply chain and purchasing focused actions and projects, identifying opportunities for total cost reduction, risk elimination, and developing and executing strategies to achieve them for an assigned value stream. Essential Functions: Duties and Responsibilities: Customer focused supply chain and purchasing management and overall team leadership across multiple functional areas of a supply chain or value stream. Problem solving and team facilitation to meet cost, quality, and delivery expectations. Implement sourcing strategies to support objectives in the area of indirect or direct commodities, providing the assigned supply chain, project, and division competitive advantage in the areas of materials, supplies, and services Locate, analyze and develop a consolidated supplier base to meet current and future supply chain and purchasing needs Provides technical leadership and direct contribution toward the development of new and existing supplier processes for assigned supply chain or project products or services Directly contributes to resolving technical issues and technical design work related to existing processes and designs as requested by the supply chain or project teams Negotiate and manage contracts/agreements for assigned supply chain or project Help implement system configuration and data requirements required for SAP set up as requested and needed 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 products or services Qualifications: Education and Experience: Minimum of 8 years of progressive Materials/procurement experience and technical knowledge in the area of medical devices, therapies, or solutions Excellent verbal and written communication skills Advanced knowledge of procurement principles BA/BS in Business, Engineering, Supply Chain, Finance or equivalent Proven ability to lead, influence and motivate others |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-23 22:55:58MinnesotaMNMinnetonka, MN26054921http://jobs.sjm.com/xml/26054921/jobUSAPlymouthAssociate - Clinical Research Job Requisition #: 12267 Date Posted: 01/23/2012 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 designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department. Duties and 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 Education, Experience, Personal and Technical Skills: BA/BS in business, medical science or nursing 2 - 4 years experience in clinical research, preferably with a medical device company 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.United StatesSt Jude Medical2012-01-23 22:56:15MinnesotaMNPlymouth, MN26054924http://jobs.sjm.com/xml/26054924/jobUSASt. PaulSenior Manufacturing Technician Job Requisition #: 12294 Date Posted: 01/23/2012 Category: Manufacturing 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: A Senior Manufacturing Technician will 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 experimental 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.United StatesSt Jude Medical2012-01-23 22:56:46MinnesotaMNSt. Paul, MN26054931http://jobs.sjm.com/xml/26054931/jobUSAMinnetonkaSenior Buyer/Planner Job Requisition #: AF13721 Date Posted: 01/27/2012 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 at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber, Senior Buyer/Planner to join our Minnetonka, MN based supply chain management team. Under the direction of the supply chain manager, the Senior Buyer/Planner will be responsible for planning production to meet customer demands and planning and ordering supplier sourced materials in support of the mission of the business unit. Impact this role will have within the AF division: Plan and schedule weekly build plans for production. Adjust schedules accordingly and manage inventory to assure 100% customer service levels. Track schedule vs. actual production, investigate over/under production. Make decisions on future build plans and finished goods inventory impact. Place purchase orders with suppliers based on SAP system reports and non-inventory requirements, and follow up with suppliers to assure on time deliveries. Set and maintain SAP system parameters (i.e. safety stocks, lead-time, yields, etc.) Work with suppliers and SJM supplier quality on implementing material pull system utilizing SAP while eliminating receiving inspection. Lead SAP implementation team for the operations departments on material planning, purchasing, production scheduling and advanced SAP functionality like supplier portal and Kanban. Coordinate work load and set priorities for the other buyer/planners working in the supply chain department. Other duties as needed Required Qualifications: Bachelors Degree. 7+ years of experience. APICS certification or greater than 75% complete. 3+ years experience in a FDA/cGMP/ISO environment. SAP experience in production scheduling, planning and purchasing of materials. SAP knowledge and implementation skills. Excellent communication skills and the ability to successfully interact with all levels of the organization. Experience with master scheduling, lot control, lean and/or six sigma continuous improvement methodologies within a regulated environment. Proven ability to represent company with outside suppliers in a professional manner. Proficient computer skills in a Windows based environment. Excellent reputation for building relationships across various levels of an organization. Organized, on-time, and detailed project management skills. Energized attitude. Preferred Qualifications: Medical device industry experience To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-27 19:09:00MinnesotaMNMinnetonka, MN26158774http://jobs.sjm.com/xml/26158774/jobUSAMinnetonkaSenior Labeling Engineer Job Requisition #: AF13726 Date Posted: 01/27/2012 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 at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, hands-on Engineer to develop and drive AFD wide instructions for use (IFU) strategy (brand, regulatory, format) for Labels and Label printing. The Labeling Engineer will develop and influence relationships with cross functional teams associated with the labeling process. Youll set the standard for developing a library of labeling practices and format for the division. The Engineer will define an innovative and flexible approach to labeling design and label printing for all AFD sites. Impact this role will have within the AF division: Leads others to develop, design and create labeling that meets the developed strategy and guidelines that provide ease of use for the operations team. Learn and provide technical expertise on label printing processes and schema. Prepares and executes a strategy for mistake proofing the label printing process. Designs and creates labeling that meets the developed strategy and guidelines that provide ease of use for R & D, manufacturing engineering, operations, quality, regulatory and internal labeling team members Develops, drives, validates, and documents AFD wide consistency for labels and label printing. Analyzes various label formats, printing technologies, printing process flows and the factors that drive simplification of the labeling process. Required Qualifications: Bachelors of Science in Engineering Minimum experience of 8 years with a BS or 6 years with a MS. 3-5 years medical device experience working with product labeling, packaging, design dossiers and/or regulatory labeling Strong engineering skills- component specifications, assembly drawings, manufacturing procedures, validation processes and the ability to transfer engineering knowledge to paper Familiarity with standards for bar coding, UDI, label printing processes, software and printer hardware and a drive to understand all factors critical to compliant labeling. Microsoft Office Suite, Microsoft Project, Label printing programs Ability to self prioritize multiple and conflicting tasks 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: MS in Engineering Experience leading a Labeling program Ten+ years experience in a development and/or manufacturing environment To learn more and apply visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-01-27 19:09:07MinnesotaMNMinnetonka, MN26158781http://jobs.sjm.com/xml/26158781/jobUSASt. PaulSr Quality (Microbiology) Engineer Job Requisition #: AF13752 Date Posted: 02/06/2012 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 Quality Engineer that will focus on Microbiology for the division. The engineer will focus on microbiology, biocompatibility, materials, and chemical characterization to ensure final devices are safe and efficacious. This individual is also responsible for supporting sterilization, controlled environmental monitoring, and vendor audits. The role will act as the SJM Atrial Fibrillation division (AFD) subject matter expert (SME) with responsibility for harmonizing practices throughout the division and providing biocompatibility and chemical characterization support to the AFD manufacturing sites, the division product development team, and the division R&D team. Impact this role will have within the AF division: • Develops and implements the biocompatibility and chemical characterization requirements for new products or changes to existing products. Partners with Product Development and R&D to ensure products are safe for users. • Provides technical support for division teams and manufacturing sites for issues related to biocompatibility and chemical characterization requirements; act as SME to institute best practices. • Provides technical support for sterilization needs; including but not limited to validation requirements for new or existing products, annual validation of existing sterilization cycles, and audits of sterilization vendors. • Monitors and communicates changes to applicable industry standards and implement them within the business. Author and/or revise division and site documents related to biocompatibility, chemical characterization, etc. Provides training to appropriate division and site personnel. • Effectively communicates and works with other organizations, including Quality Engineers, Research & Development, Product Development, regulatory bodies, and customers. Supports global SJM initiatives. Required Qualifications: • Engineering degree or BA/BS in microbiology and engineering experience. • Minimum 5-7 years in medical device or pharmaceutical industry with direct experience with microbiology and biocompatibility. Demonstrated trouble shooting skills in complex situations outside of routine testing or monitoring. • Strong knowledge of FDA Quality System Regulations and ISO (11135, 11137, 10993) regulations. • Experience with Quality System auditing. • 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: • ASQ CQE, or equivalent. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-06 21:22:30MinnesotaMNSt. Paul, MN26341873http://jobs.sjm.com/xml/26341873/jobUSASt. PaulProduct Data Mgmt Systems Analyst Job Requisition #: AF13754 Date Posted: 02/06/2012 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, Systems Analyst to provide application development and configuration support to existing users as well as providing technical expertise to ongoing implementation activities. The role is responsible for understanding business requirements and user needs, and communicating them to IT for implementation. The position also involves assisting with implementation by participating in testing, developing training materials, updating SOPs, and delivering training to users. The PDM Systems Analyst focuses on the division’s implementation of tools and processes for document, records, and change control to ensure they provide significant business value. Impact this role will have within the AF division: User Support & Training: • Creates and maintains training materials • Delivers new user training • Provides follow-on training including targeted “How-To”, Tips & Tricks sessions, system updates, functional group, and one-on-one. IT Liaison: • Creates, reviews, and prioritizes system modification requests • Participates in or leads data preparation or cleansing activities • Participates in software validation and smoke testing activities SharePoint Site Administration: • Improves and maintains the department’s internal and customer-facing sites • Works with IT to implement and maintains Windchill access sites Special Projects / CR Processing Backfill: • Augments or fills in for Document Control resources as needed to create or process Change Requests for special projects or during times of increased workload. Metrics Management: • Prepares process metrics for use by management to identify process improvement opportunities and to present at quarterly quality management reviews. Required Qualifications: • Bachelor’s degree in Engineering, Business, IT, or a related technical or professional field. • 3+ years medical device experience working with documentation, records, and/or quality systems. • Ability to bridge communication between technical and business areas for a full and complete understanding of expectations. • Strong technical writing and presentation/educational materials skills. • Strong understanding of FDA and ISO 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: • Extensive experience with the Windchill PDM software and related applications including Creo Elements (Pro/ENGINEER), ArborText, PPMLink, MathCAD, or Integrity Requirements & Software Lifecycle Management. • Experience with SharePoint development. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-06 21:22:19MinnesotaMNSt. Paul, MN26341866http://jobs.sjm.com/xml/26341866/jobUSASt. PaulSr Regulatory Affairs Specialist Job Requisition #: AF13755 Date Posted: 02/06/2012 Category: Regulatory Affairs 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, experienced, Senior Regulatory Affairs Specialist. The Specialist will ensure that AFD products and procedures comply with regulatory agencies. The Specialist will contribute on cross functional teams, partner with the FDA, lead AFD regulatory projects and standards supporting all AFD products. Impact this role will have: • 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 products with self certified CE Marks • Provide leadership and guidance to other members of the RA staff • Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations. • Provide Regulatory leadership to development teams: o Provide global strategic input (including all feasible alternatives and associated risks) o Drive cross functional alignment with issues that could have Regulatory ramifications • Build partnerships with competent authorities (FDA, Notified bodies, Health Canada). • Build strategic partnerships to further departmental and organizational objectives • Update Technical Files on annual basis • Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations • 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 Required Qualifications • BA or BS in a technical discipline with at least 5-8+ years technical experience • 5+ years regulatory experience • Working knowledge of FDA regulations including 510(k), IDE, PMA, compliance, labeling and advertising • Strong technical and product knowledge • Experience with EU and Canadian medical device regulations and submissions • Motivating leadership and partnership skills • Strong written and oral communication and negotiations skills • Proven experience in managing multiple complex projects Preferred Qualifications • Regulatory Affairs Certification (RAC) preferred. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-06 21:22:20MinnesotaMNSt. Paul, MN26341867http://jobs.sjm.com/xml/26341867/jobUSASt. PaulSr. Engineer - Research & Development Job Requisition #: 11731 Date Posted: 10/03/2011 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 Summary: This position will take an active role on specific projects to develop new test methods, model development, and preclinical activity. This individual 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. This candidate must have a strong ability to apply knowledge of engineering techniques to provide imaginative solutions to a wide range of difficult problems. The candidate should have a fundamental understanding of biomedical materials, biological systems, and test method development and validation methodology. Out of the box thinking is a key area for this position to merge the in-vitro and in-vivo experience to collect data and drive new medical device design. This individual will eventually train and direct other members of the staff to utilize test methods and models for future development needs. Education and or Experience: - MS with 5+ years experience, or BS with 5-7 years experience. Expertise in mechanical and/or biomedical engineering is required. - Must have extensive background in test method development for medical devices. - Ability to develop test methods and teaching models to simulate in-vivo environments. - Proficient in designing fixturing and medical device design. Capable of bringing an idea to a practical application with a new test method or device. - Ability to design and develop experimental test setups to evaluate new concepts in cardiovascular therapy. - Proficient with computers and using 3D design software (ex. Solidworks) - Previous experience with R&D product development teams in medical device industry desired. - Willingness to perform hands on lab work. - Concise, organized, can multitask with the ability to prioritize. - Excellent written and verbal communication skills. - Communicates well with all levels of management and employees. - Candidate must work well in collaborative environment across functional areas. - Some familiarity with Fluoroscopic and Echostenography based medical techniques. - Experience utilizing clinically based analysis tools (CT scan analysis software) preferred. - Experience in RF ablation and/or in electrode stimulation devices is a plus. - 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 preferred. - Knowledge of the electrode/tissue interface of electrical based systems for cardiovascular therapy preferred. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-10-04 08:27:55MinnesotaMNSt. Paul, MN24025099http://jobs.sjm.com/xml/24025099/jobUSASt. PaulSr. Director, HR Business Operations Job Requisition #: Corp 12014 Date Posted: 02/03/2012 Category: Human Resources Information Technology Information Services 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 newly created position is responsible for the strategic direction and operational effectiveness of the Human Resource Information System (HRIS), Learning Management System (LMS) and HR Shared Service Center. The position will be responsible for aligning processes and technical solutions with current and future business needs. Responsibilities: HRIS: • Lead the coordination of overall HR information standards within all divisions. • Lead the process to define the prioritization of new projects and support needs. • Ongoing analysis of the HR information system processes and recommending improvements. • Serve as project manager for significant HRIS projects. • Recommendation of specifications and user test plans for any new HR functionalities. • Development of requirements and testing plans for any new HR functionalities. • Establish and maintain HRIS security and integrity controls, ensuring that a disaster recovery plan is implemented and tested regularly. • Serve as the HR liaison to IT and partner with the IT department to accomplish results. • Assist with the relationship management of existing and future technology partners. • Provide recommendations and direction on HRIS related best practices, policies and procedures. • Drive the process for determining resource allocation and project prioritization. Shared Services: • Manages the delivery of the HR shared services including employee record maintenance, HR data stewardship, HR policy documentation, HR call center, and general HR administration. Ensures service levels are maintained to meet or exceed standards. • Responsible for hiring 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 insures safety requirements for work areas are met within department. • Accountable for the performance of subordinate managers’ team effectiveness. Maintains a strong client focus. Creates an environment that consistently fosters employee understanding of quality and motivates all employees to actively participate in the process of continuous quality improvement. • Leads change initiatives to increase usage and adoption of enhanced support services. • Collect and analyze operational performance data to drive process improvements and increase efficiency and effectiveness. • Serves on project teams as assigned. • Establish and maintain strong internal controls; driving and maintaining financial processes for the HR shared services function. Learning Management System: • Owner of the global, enterprise-wide LMS. • Establishing strategic direction for LMS with consideration given to business needs and compliance requirements. • Develop and ensure standards and processes are in place to effectively/efficiently manage learning data across the globe. • Own LMS vendor relationship. • Integrate LMS with performance and talent management systems and processes. • Work with divisions/groups to launch, maintain and drive usage of LMS. • Provide guidance and best practices for LMS. • Ensure effective training programs are in place for LMS administrators and govern global LMS administration access to ensure expertise and overall data integrity are maintained. Qualifications: • A four year degree in a related field. A Master’s degree in Business, Human Resources or Computer Science is preferred. •10+ years of experience predominately in a significant systems area (finance, HR, business systems, etc.). • Experience with major ERP packages such as Oracle or SAP *3+ years of experience either managing or providing significant project leadership to the HRIS function. • Additional HR generalist experience is helpful. • Demonstrated project management/leadership skills with significant user side experience. Leading a major conversion or other significant project is desired. • Excellent written and interpersonal communication skills with demonstrated strengths in matrix management, negotiation, influencing and team building. • Demonstrated knowledge and hands-on experience with human resource processes. • Strong organizational skills. • Projects a strong customer service orientation. *Ability to travel domestically and internationally as needed, estimated at 20% |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-03 19:00:35MinnesotaMNSt. Paul, MN26298529http://jobs.sjm.com/xml/26298529/jobUSAMinnetonkaEngineer - Process Development Job Requisition #: 12370 Date Posted: 02/02/2012 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: 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: 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.). Qualifications: BS degree in Engineering or Technical Field; advanced degree preferred 2 - 4 years manufacturing experience Experience designing and testing medical devices required Experience developing manufacturing processes and technologies and designing for manufacturability required |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-02 18:22:12MinnesotaMNMinnetonka, MN26274268http://jobs.sjm.com/xml/26274268/jobUSAMinnetonkaEngineer - Manufacturing Job Requisition #: 12351 Date Posted: 02/01/2012 Category: Manufacturing 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 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 Qualifications: Mechanical Engineering degree required 2-5 years manufacturing engineering experience Medical device experience preferred Strong analytical, problem solving and project management skills |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-01 18:38:28MinnesotaMNMinnetonka, MN26244514http://jobs.sjm.com/xml/26244514/jobUSASt. PaulSoftware V&V Engineer II Job Requisition #: AF13689 Date Posted: 02/02/2012 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 The Software Test Engineer position brings a testing expertise to the Verification and Validation of the EnSite system. This high caliber individual will have significant input into 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 teams 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, Hazards Analysis, and Design Reviews for new features. Evaluate, recommend, and employ software test tools to ensure software quality. Designs new test suites for new features & functionality. Provides V&V perspective to R&Ds 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 field of software test engineering. Perform other duties as assigned Required Qualifications: Bachelors degree in computer science or equivalent experience. Two or more years professional experience in software test engineering or related field. Working knowledge of cardiac anatomy. Polished written and verbal communication, interpersonal, facilitation, presentation skills. Experienced in quantitative, analytical, organizational, and follow-up skills. Effectively engages in conversations with all levels of employees, management and customers. Excellent documentation skills in delivering information that adds value to management's decision making process. Strong technical skill set including spreadsheet, word processing, PowerPoint and specialized applications. Experience with Windows and LINUX operating systems. Experience with software development lifecycle management tools. Two or more years in FDA-regulated industry. Preferred Qualifications: An advanced credential in a relevant discipline/concentration such as Biological Sciences or Engineering. Professional Health Science certification or engineering. Current industry knowledge of electrophysiology and/or cardiac rhythm management. Experience with C++, perl, and python programming languages. Masters degree in computer science or equivalent experience To learn more, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-02 18:22:16MinnesotaMNSt. Paul, MN26274279http://jobs.sjm.com/xml/26274279/jobUSAMinnetonkaBuyer Job Requisition #: 11718 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 Position Summary: To provide Materials Buying and Component Planning support for both production and non-production items. This may include quoting, purchasing, supplier management, production planning, inter-company STO management and administrative support. Responsible for the purchasing and planning of materials, services, and supplies used in the manufacturing of new product development and existing product lines as required. Essential Functions: 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 and SJM development teams. Monitors supplier performance, communicates and take action to maintain a high level of supply availability Sourcing/quoting requirements for goods and services required to support the new product development objectives. Reviews S&OP and independent demand inputs and adjusts component production plans and STO orders to support changes in demand plans Coordinates updates of inventory targets, safety stock levels, and inter-company planning parameters to support changes in build plans Coordinates the return of damaged goods, replacement items, or credit arrangements with suppliers. Arrange for vendor corrective action and works with SQE and supplier to improve quality. Plan and schedule deliveries to optimize inventories in support of production schedules, work with suppliers to maintain supplies to minimize shortages and disruption of SJM production or development schedules With assistance of QA department, audit suppliers and track their performance Prepares POs per requirements of MRP or manual purchase requisitions and monitors delivery of product against POs Works with other manufacturing site buyer / planner and operational team members to optimize Raw, WIP, and Semi-Finished Goods inventory levels and support all production needs Develops end-to-end supply plans and allocation strategies as needed for assigned parts being bought and planned. Material documentation filing and administrative support Maintain and update Supplier Information Database (SID) and Approved Supplier List (ASL) as required Supplier evaluation and management Supply and catalog item materials support for new R&D projects Maintain inventory planning levels based on forecasts internally and at suppliers who are on VMI / SMI programs Communicating clear, concise information via phone, e-mail or other methods Work with inventory control to resolve issues Special projects intended to reduce cost, increase efficiency, etc Other duties as assigned Other Duties: Filing documents and/or records according to policy, organizing skills, meeting participation. 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 work with minimal supervision. Works in accordance with defined policies and procedures, and with discretion and appropriate business ethics Relationships: Internal: 1. Operations - to understand requirements of goods and services and be able to research/recommend suppliers 2. Finance - To insure payments terms are correct and to support actions to correct billing discrepancies 3. Shipping/Receiving - To identify opportunities to improve receipt processing and track goods External: Suppliers - to communicate requirements, place orders and discuss product or service quality or delivery performance. Equipment: Personal computer, calculator, printer, copier, scanner Working Conditions: Typical office environment, largest amount of time is sitting. May need to be in manufacturing area occasionally which requires wearing personal protective equipment due to noise level and safe walking. Travel to other locations and supplier sites may be required. Physical Demands: Reasonable accommodations may be made to enable individuals to perform the essential functions. Qualifications: Education and/or Experience: 2 year Associates or 4 year Bachelors Degree in related business field. (Supply Chain, Finance, Business Admin, etc) Advanced degree is highly desirable. Entry level buying, planning or supply chain work or internship experience (0-2 years) in a Materials or Planning environment expected, preferably in a medical device setting Understanding of MRP, global purchasing, planning, and production principles SAP, JDEdwards, Oracle MRP/ERP software experience a plus High attention to detail Excellent organizational and communication skills Is able to manage entire planning and purchasing cycle from initial quoting to confirmed order and all associated planning and MRP usage functions Is able to work independently on projects Is able to identify cost savings opportunities and implement plans to realize savings Knowledge of ISO, GMP, JIT, ERP, and Lot control required Experience in the medical manufacturing field a plus. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-01 18:38:59MinnesotaMNMinnetonka, MN26244544http://jobs.sjm.com/xml/26244544/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 Position Summary: This position is responsible for setting and executing supply chain and purchasing strategies for assigned goods and services required within the Supply Chain or Project Team they are assigned. In conjunction with these supply chain expectations, this position will also directly contribute to the resolution of technical issues for new and existing products and processes where suppliers or supply items are involved. Resources in this role may be responsible for leading and coordinating cross-functional project activities, defining supplier process improvement experiments, internal process development activities, and coordinating product/process validations with other cross-functional technical teams. Key deliverables for this position are leading and managing supply chain and purchasing focused actions and projects, identifying opportunities for cost reduction, and developing and executing strategies to achieve them. Essential Functions: Duties and Responsibilities: Implement sourcing strategies to support objectives in the area of indirect or direct commodities, providing the assigned supply chain, project, and division competitive advantage in the areas of materials, supplies, and services Locate, analyze and develop a consolidated supplier base to meet current and future supply chain and purchasing needs Provides technical leadership and direct contribution toward the development of new and existing supplier processes for assigned supply chain or project products or services Directly contributes to resolving technical issues and technical design work related to existing processes and designs as requested by the supply chain or project teams Negotiate and manage contracts/agreements for assigned supply chain or project Help implement system configuration and data requirements required for SAP set up as requested and needed 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 products or services Other Duties: Support activities performed by other supply chain or project team leaders Manage inventory supply levels to meet teams objectives Manage product build status and keep team informed of projected completion dates Manage build and shipping logistics to meet clinical trial needs Partner with clinical to develop an inventory strategy to meet clinical trial needs Environmental: Understand the following with respect to the environmental management system (EMS): The Environmental Policy; The employees specific roles, responsibility and authority, The importance of conformance with the environmental policy, procedures and requirements of the EMS, The potential consequences of departure from procedures, Who to contact in the event of questions or concerns related to the EMS, and The notification process in the event of an environmental emergency Accountability/Supervision: Expected to work with minimal supervision, and achieve objectives identified using internal and external resources. Operates within defined policies and procedures and is expected to present recommendations for improvements. Relationships: Internal: 1. Operations - to understand requirements of goods and services and be able to research/recommend suppliers 2. Research and Development to work with teams defining and identifying requirements or specifications for materials or services that have unique properties or specifications not available from CVD approved suppliers. 3. Finance - To insure payments terms are correct and to support actions to correct billing discrepancies related to supplier activities 4. Shipping/Receiving - To identify opportunities to improve receipt processing and track goods and other supply chain logistics activities 5. Executive/Senior Management to present recommendations on areas of policy, process and alternative means of supply as risk or cost challenge arise. External: Suppliers to manage performance and identify opportunities for improvement, to negotiate business terms and conditions, to research potential alternative suppliers. Associations to network with peers at other organizations and to learn best practices of other organizations that can lead to improved Divisional performance. Equipment Utilized: Personal computer, telephones, printer, copier scanner, calculator Working Conditions: Typical office environment, largest amount of time is sitting. Travel to other CVD locations and supplier locations may be periodically required. Some travel outside of the home country may be needed. Physical Demands: Periodic access to manufacturing areas is required, creating the needs for personal protective equipment due to noise levels and materials used. Qualifications: Minimum of 8 years of progressive Materials/procurement experience and technical knowledge in the area of medical devices, therapies, or solutions Excellent verbal and written communication skills Advanced knowledge of procurement principles BA/BS in Business, Engineering, Supply Chain, Finance or equivalent Proven ability to lead, influence and motivate others Other Requirements: Knowledge of ISO, GMP, JIT, ERP, and Lot control required Experience in the medical manufacturing field a plus. Proficient computer skills in a Windows based environment. Understanding of MRP, purchasing, and production principles Core Competencies: Communication Skills Teamwork & Interpersonal Effectiveness Job Knowledge Customer Focus Quality/Continuous Improvement Productivity/Efficiency Leadership Competencies: Business Planning Employee Development Decision Making Leading & Directing Teamwork Results Orientation Affirmative Action/EEO/Diversity Accountability |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-01 18:39:03MinnesotaMNMinnetonka, MN26244547http://jobs.sjm.com/xml/26244547/jobUSASt. PaulSr Electrical Technician Job Requisition #: AF13723 Date Posted: 02/10/2012 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, results-oriented Senior Electrical Technician to provide design and process development support to the Research and Development group in the area of medical device design. Impacts this role will have: • Design prototype/production test equipment including procurement, build and debug. • Electro-mechanical and printed circuit board assembly requiring soldering (SMT and through-hole), wiring, mechanical fabrication, and established production methods. • Understand electrical schematics and mechanical drawings to troubleshoot electro-mechanical systems to the component level. • Write and execute test protocols and reports. • Release controlled documentation. • Work effectively with cross-functional teams. • Assist, train, and communicate technical issues effectively to engineers and operators. Qualifactions: • HS degree and minimum five years electromechanical experience or 2 year degree and 3 years of electromechanical experience. • Required experience operating various laboratory equipment such as oscilloscope, power supply, multi-meter, and function generator. • Required soldering/wiring skills. • Must be able to read and understand electrical schematics. • Strong understanding of digital / analog circuitry. • Strong troubleshooting experience. • Ability to work independently with good organizational skills and attention to detail. • Strong oral and written communication skills. • Working knowledge of Microsoft Word and Excel Preferred Qualifications: • Medical device experience. • Working knowledge of mechanical and electrical CAD tools. • Schematic Capture / PCB Layout experience, Altium preferred. To learn more, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-10 23:21:13MinnesotaMNSt. Paul, MN26467907http://jobs.sjm.com/xml/26467907/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 Associates Degree in equipment technology plus 10-15 years 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.United StatesSt Jude Medical2012-02-10 23:22:04MinnesotaMNSt. Paul, MN26467982http://jobs.sjm.com/xml/26467982/jobUSAMinnetonkaAssembler - 2nd Shift Job Requisition #: AF13785 Date Posted: 02/10/2012 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, 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 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. • 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. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-10 23:21:15MinnesotaMNMinnetonka, MN26467912http://jobs.sjm.com/xml/26467912/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 position Duties and Responsibilities: • Manage the successful and timely execution of all device clinical trials for CVD. • 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. • Ensure all staff maintain relevant professional certifications and remain current with the latest development in interventional cardiology and structural heart defects. • Develop and maintain strong relationships with principal investigators at clinical trial sites. • Ensure that AGA Medical is using the most current tools in the management of clinical trials. Education, Experience, Personal and Technical Skills: • BA/BS in life sciences or nursing. • Advanced degree in life sciences or nursing a strong plus. • 5-10 years experience in clinical research management, preferably medical device company developing products for use in interventional cardiology. • Demonstrated and successful management experience of a clinical team of a minimum of 5-10 professionals. • Demonstrated knowledge of and experience with GCP and all US regulations. • Knowledge and experience with European and Japan device clinical trials a strong plus. • Hands on experience in the preparation of PMAs and 510(k)s or equivalent non-device regulatory submissions. • 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 and willing to travel 40-50%. • Excellent communication, problem-solving and organizational skills. • Computer proficiency including Microsoft Office applications. Physical Requirements: • Frequent computer monitor and keyboard use. • Extensive travel. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-10 23:21:31MinnesotaMNPlymouth, MN26467931http://jobs.sjm.com/xml/26467931/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.United StatesSt Jude Medical2012-02-13 22:34:16MinnesotaMNPlymouth, MN26501390http://jobs.sjm.com/xml/26501390/jobUSAPlymouthPrincipal Regulatory Affairs Specialist Job Requisition #: 11284 Date Posted: 06/27/2011 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 our Cardiovascular Division: Job Overview As a Principal Regulatory Affairs Specialist you will support, develop, and follow SJM CVD and Amplatzer product procedures, compliance programs and ethical guidelines/requirements; evaluate the regulatory environment and provide internal advice throughout the lifecycle of the product (e.g., concept, development, manufacturing, marketing) to ensure product compliance; and provide regulatory intelligence to develop local and regional regulatory strategies. Responsibilities: • Participate in initiatives to identify regulatory requirements and develop submission processes for new AGA markets. • Identify, monitor, and submit applicable amendments or notifications to regulatory authorities to comply with regulations. • Ensure regulatory compliance of labeling. • Evaluate proposed manufacturing changes on pre-clinical and clinical development and regulatory submission strategies. • Comply with product post-marketing surveillance requirements to meet conditions of approval. • Participate in crisis/issue management team (e.g., product recall, counterfeiting) and assess the regulatory impact of an event and proposed resolution. • Maintain product licenses and submit renewals as required. • Provide required information in support of product reimbursement or tenders. • Participate in and/or lead process improvement initiatives to streamline regulatory submission preparation processes for assigned markets. • Maintain records on legislation, regulations, guidelines, standards, and related issues for background purposes to facilitate compliance. • Assist other departments to develop SOPs to ensure regulatory compliance. Basic Qualifications: • Bachelors degree in business, engineering or sciences • 8+ years industry experience in medical device regulatory affairs • 4+ years of regulatory affairs experience with Class III medical devices • Knowledgeable and able to interpret and operate using federal and other regulations (e.g., Quality System Regulation, Code of Federal Regulations, Medical Device Directive) • Excellent organizational, interpersonal and communication (verbal and written) skills • Computer proficiency in MS Word, Excel, and Outlook • Ability to interact with a range of personalities and many levels of the organization Preferred Qualifications: • Masters degree in business, engineering or sciences • International regulatory affairs experience with Class III medical devices |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2011-06-27 18:49:12MinnesotaMNPlymouth, MN22039315http://jobs.sjm.com/xml/22039315/jobUSASt. PaulIntern - R&D Job Requisition #: 12275 Date Posted: 02/07/2012 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 in our Cardiovascular Division: Job Overview Duties and Responsibilities: Position is responsible for data mining current medical device records for materials of construction information. Individual will be responsible for assisting in developing a global environmental management database to document component level chemicals/materials information for products across the division. Position will also assist with continuous improvement of the electronic lab notebook used in the S&T lab. The candidate will work with a cross-functional team including S&T, R&D, Quality, Supply Chain and Operations to collect information, conduct assigned tasks, analyze and organize data, and make recommendations. Education and/or Experience: Current student pursuing a B.S., M.S. or Ph.D. degree in chemical industrial hygiene, materials, or environmental science are preferred. Student must be enrolled in the 2012 fall semester. General interest in Medical Device. Experience with Excel, Word, PowerPoint is a plus. Concise, organized, can multitask with the ability to prioritize. Proficient with computers. Excellent written and verbal communication skills. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-16 19:29:22MinnesotaMNSt. Paul, MN26571289http://jobs.sjm.com/xml/26571289/jobUSASt. PaulOperations Engineer I Job Requisition #: AF13790 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.United StatesSt Jude Medical2012-02-16 19:29:43MinnesotaMNSt. Paul, MN26571333http://jobs.sjm.com/xml/26571333/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.United StatesSt Jude Medical2012-02-16 19:29:43MinnesotaMNSt. Paul, MN26571349http://jobs.sjm.com/xml/26571349/jobUSASt. PaulMechanical Engineer I Job Requisition #: AF13792 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.United StatesSt Jude Medical2012-02-16 19:29:44MinnesotaMNSt. Paul, MN26571357http://jobs.sjm.com/xml/26571357/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: CRT13045 Date Posted: 02/15/2012 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 Cardiac Rhythm Management Division (CRMD): 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 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). • 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. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-16 19:29:46MinnesotaMNMinnetonka, MN26571361http://jobs.sjm.com/xml/26571361/jobUSAMinnetonkaQuality Inspector II Job Requisition #: AF13784 Date Posted: 02/15/2012 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 at our Atrial Fibrillation Division. Job Overview We are seeking a talented, results-oriented Quality Assurance Inspector for our Minnetonka location. The successful candidate will be primary responsible for inspection of incoming components, or manufactured medical devices, and documenting these activities. Impacts this role will have: • Support Quality inspection activities during the manufacturing of Diagnostic and Ablation Catheters. • Support production line including, NCMR, Quality Inspection and GDP adherence of Shop Floor Paperwork. • Documentation of in-process findings on inspection forms/audit reports. • Documentation of non-conformances on NCMR’s as appropriate. • Other Duties as assigned. Qualifications: • Must have a high school diploma/GED. • 0-3 years experience in Quality Assurance performing inspection duties in a medical device environment. • Experience with hand tools, gages, pressure and force gage testing. • Knowledge of FDA QSR and ISO 13485 guidelines. • Good communication and computer skills. To learn more or to apply, visit our web site at www.sjm.com. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-15 19:37:42MinnesotaMNMinnetonka, MN26541092http://jobs.sjm.com/xml/26541092/jobUSAMinnetonkaAssembler - 1st Shift Job Requisition #: CRT13044 Date Posted: 02/15/2012 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 Cardiac Rhythm Management Division (CRMD): 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 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). • 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. |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-15 19:36:11MinnesotaMNMinnetonka, MN26541042http://jobs.sjm.com/xml/26541042/jobUSASt. PaulSr Post Market Surveillance Specialist Job Requisition #: AF13786 Date Posted: 02/15/2012 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 Post Market Surveillance Specialist. Working without appreciable supervision, this successful candidate will be reviewing and investigating medical device complaints and maintaining quality documents as required ensuring compliance with various regulatory agencies. This individual will also coordinate resolution of complaints and ensure that timely investigations are conducted and prepare and file reports as appropriate with regulatory agencies and bodies (including Competent Authorities). The required regulatory reports by geography include but are not limited to; USA (MDR), European Union (Vigilance), Canada, Australia, and Japan. Impact this role will have within the AF division: • Generate customer letters as appropriate upon closure of the investigation. Establish and improve complaint handing procedures. Remains abreast of and consults on regulations tied to complaint management. • Independently conceives, plans, and conducts complex and/or original projects as required. • Identifies relevant sources of information and utilizes them to make decisions. • Responsible for successful completion of moderate risk assignments that will have a significant impact on the department. • Works cooperatively as well as productively on assigned project teams. • Proactively identifies and shares opportunities, concerns, and solutions with coworkers. • Completes comprehensive reports and makes presentations. • Mentors and oversees the technical duties for less experienced staff members including peer review of complaint files • On a daily basis receive, review and investigate medical device complaints / Coordinate return of devices / Manage timely investigation / Manage database input • Prepare, file and maintain correspondence for external regulatory reports for the applicable geographies • Review, interpret and enter investigation results into the database, generate customer letters and ensure timely closure of complaint files to meet performance objectives for processing time • Complaint Handling System Liaison / Complaint Handling System Department Support / Staff Training / Administer Training Manual • Maintain and update the area operating procedures (SOPs) as required. Improve the complaint handling process. • Other duties, as required, including presentations to internal customers and employing change management techniques to implement a robust, compliant complaint handling process. Required Qualifications: • Four-year degree preferred or equivalent experience required (e.g. quality or clinical). • Must possess a high level of knowledge and understanding of a medical device and/or complaint management systems. • Must be able to work independently with minimal supervision. • Candidate must demonstrate strong written and oral communication skills and must communicate and document product performance and complaints clearly and concisely using objective evidence and language. • Candidate must demonstrate computer literacy and proficiency with standard office software applications and the complaint management information system/database. • Candidate must possess a full working knowledge of medical device regulations as it relates to product performance reporting and complaint handling for all effected geographies including but not limited to; USA (MDR), European Union (Vigilance), Canada, Australia, and Japan. • 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: • 3-5 years working experience preferred. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-15 19:36:15MinnesotaMNSt. Paul, MN26541044http://jobs.sjm.com/xml/26541044/jobUSASt. PaulAPD Principal Engineer Job Requisition #: AF13788 Date Posted: 02/15/2012 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 We are seeking an experienced, high caliber, Principal Engineer supporting the installation process development for our latest technologies. Qualified candidates should have a background in capital systems for medical devices, preferably with experience in developing, installing, or maintaining angiography/fluoroscopy imaging systems. The Principal Engineer will partner with the design team and technical services team to support initial installations, develop consistent procedures, and provide diagnostic assistance during and after installation. Travel will be variable up to 50%, with most travel within the US. Impact this role will have within the AF division: • Manufacturing technology readiness level (TRL) assessment and capability analyses. • Serve as Core Team Member on electronic systems development projects. • Conceptualize new processes and testing methods using device knowledge and innovative thinking. • Development of manufacturing assembly procedures and fixturing. • Develop, review, and challenge product and process specifications. • Develop rationale for product and process specifications, including justification and supportive testing. • Create product and test equipment drawings and/or models. • Development of manufacturing test strategy, test procedures and test equipment. • Development of pFMEA. • Development of IQ/OQ/PQ protocols and reports for manufacturing equipment. • Review components for reliability, performance, and standardization. • Development of the refurbishment process, including test strategy. • Specification of DFX criteria: Design for Manufacturability and Test. • 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. • Participate and or lead root cause investigations and corrective action. • Automated test equipment development, installation, and qualification. • 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. • Coordinate and manage resources to meet detailed project timelines and milestones. • Participate in design reviews. • 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. Required Qualifications: • Bachelor’s Degree in engineering or science related field. • 9+ years experience, preferably in process development for electrical systems. • Experience with development of medical devices preferred. • Experience with a variety of manufacturing processes • Experience using Lean Sigma or other Design for Manufacturability toolset required. • Project leadership and management skills preferred. • CAD Experience in Solidworks and/or Altium preferred. • Travel required, up to 50%. Preferred Qualifications: • Advanced degree. • Experience in developing, installing, or maintaining angiography/fluoroscopy imaging systems. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-15 19:36:30MinnesotaMNSt. Paul, MN26541048http://jobs.sjm.com/xml/26541048/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.United StatesSt Jude Medical2012-02-17 20:54:58MinnesotaMNSt. Paul, MN26599535http://jobs.sjm.com/xml/26599535/jobUSASt. PaulSoftware Engineer I Job Requisition #: AF13799 Date Posted: 02/17/2012 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 develop and maintain complex features involving algorithms for the EnSite Velocity and EP-WorkMate systems and related systems. The ideal candidate will have studied 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; • Experience with one of the following: computational geometry algorithms, digital filtering algorithms or image processing. • Experience in C++. Experience working in Linux/UNIX. • Experience with multithreading, OpenMP, Qt or a similar framework. Preferred Qualifications: • Experience with CUDA and OpenGL graphics • Experience with Windows development and MS Visual Studio. To learn more, visit our web site at www.sjm.com |E-mail this position Submit Resume or C.V.United StatesSt Jude Medical2012-02-17 20:54:41MinnesotaMNSt. Paul, MN26599526http://jobs.sjm.com/xml/26599526/job