St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 11:00:19.455073USAIrvineQuality Engineer Job Requisition #: AF13886 Date Posted: 05/21/2012 Category: Engineering Quality Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, hands-on experienced Quality Assurance Engineer. This position provides quality support to our EnSite product line and works closely with manufacturing. This Engineer will monitor quality on the production floor working with inspectors. This Engineer will work closely with production engineers during product development activities to ensure quality checkpoints are in place as part of the production process. Impact this role will have: • Performs process and product qualification as outlined in a validation protocol to ensure finished products meet standards. • Works closely with production engineers to ensure quality checkpoints are in place as part of the production process and that processes are clear and concise. • Assists in the implementation of changes required as a result of internal audit findings. • Assists with IQ/OQ during development stage in preparation for process implementation. • Participates on new product development cross-functional teams. • Performs material processing. • Performs statistical analysis reports on a monthly basis. Required Qualifications: • Bachelor’s degree in Electrical Engineering • 3+ years of experience in a quality assurance role within a manufacturing environment • Experience with different types of testing including analytical testing, performance testing, design verification testing, material testing, and chemistry • Knowledge of standards • Experience with materials testing, analytical testing, performance testing, biocompatibility testing, design verification testing • Experience supporting a manufacturing environment • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Soldering certification • Medical device experience |E-mail this position Submit Resume or C.V.2012-05-21 20:25:06United StatesSt. Jude MedicalCaliforniaAF13886CAIrvine, CA28837110http://jobs.sjm.com/xml/28837110/jobUSAIrvineSystems Engineer I Job Requisition #: AF13885 Date Posted: 05/21/2012 Category: Systems Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber APD Systems Engineer I. The Advanced Process Development-Systems (APDS) group develops processes and test systems to manufacture new electronic systems for the Atrial Fibrillation Division. The group also provides ongoing product engineering support for key quality improvements and cycle time reductions. As an Engineer I, the individual will execute activities on key new product development programs and product support initiatives. Impact this role will have within the AF division: Uses engineering knowledge to participate in the development of innovative medical devices or components/subsystems in support of company’s strategic plan. Conducts process development work as part of a major project. Performs analyses to develop process specifications. Provides technical information concerning manufacturing techniques, components, and test algorithms. Completes the following activities as requested: • Conceptualize new processes and testing methods using device knowledge and innovative thinking. • Develop manufacturing assembly procedures and fixturing using mechanical, electrical, and software engineering skills. • Develop test procedures and test equipment using mechanical, electrical, and software engineering skills. • Develop, review, and challenge product and process specifications. • Create product and test equipment drawings and/or models. • Participate in pFMEA activities. • Generate IQ/OQ/PQ protocols and reports for manufacturing equipment. • Review components for reliability, performance, and standardization. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction, quality improvements, and component obsolesence. • Review engineering change orders. • Run empirical and experimental analysis. • Work with outside consultants, vendors, and the medical community. • Conduct work in accordance with design control and quality system requirements. • Participate in design reviews. • Work on process design and development for new atrial fibrillation mapping, visualization, and recording systems. Required Qualifications: • Bachelor’s Degree in Engineering or Scientific discipline, advanced degree preferred. • 0-3 years experience, preferably in process development for electrical systems. • Experience with development of medical devices preferred. • CAD Experience in Solidworks and/or Altium preferred. |E-mail this position Submit Resume or C.V.2012-05-21 20:25:02United StatesSt. Jude MedicalCaliforniaAF13885CAIrvine, CA28837108http://jobs.sjm.com/xml/28837108/jobUSASylmarParalegal/Admin Asst. Job Requisition #: 13097 Date Posted: 05/17/2012 Category: Legal Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working under limited supervision, organizes, plans and performs a variety of secretarial, clerical, and administrative support duties, such as (but not limited to): receiving/screening/directing phone calls/faxes/e-mails; making travel arrangements; scheduling appointments; arranging meetings; preparing correspondence/reports/documents/presentations; collecting/distributing data; and maintaining paper/electronic filing systems. Takes initiative to improve work product and processes. May be accountable for reviewing work of less experienced employees for quality and content. Adapts existing work methods to different situations. Can resolve unusual, nonstandard problems; refers only significant deviations from approved policy/practice to supervisor or more senior level personnel for resolution. Requirements/Education: Paralegal certification.2 or more years of progressively more responsible paralegal experience. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Incumbents are required to work cooperatively and productively with others. Demonstrated organizational skills, attentiveness to detail, and the ability to work under general supervision is required. Must be adept at handling multiple assignments in a timely manner while meeting assigned deadlines. Must also have demonstrated verbal and written communication, interpersonal, organizational and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: Bachelor's. Must be a good listener, compassionate, detail-oriented and meticulous. Must be able to juggle many assignments at once. Must be a team player. Professionalism is of utmost importance. This person is part claims administrator and part warranty administrator. |E-mail this position Submit Resume or C.V.2012-05-17 20:38:19United StatesSt. Jude MedicalCalifornia13097CASylmar, CA28770393http://jobs.sjm.com/xml/28770393/jobUSALos AngelesDatabase Administrator (DBA), Senior Job Requisition #: 13195 Date Posted: 05/15/2012 Category: Information Technology Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview St. Jude Medical, Inc, is looking for a Sr. DBA to join this outstanding IT team! There are many interesting projects within the Security arena that this team member will be working on! Consider joining the IT team at St. Jude Medical! Summary As a part of the Information Technology (IT) organization, the Sr. Oracle DBA will maintain the divisions relational databases including both Decision Support Systems and Online Transactional Processing. • Installs, configures and upgrades database software on various platforms. • Responsible for providing and insuring data availability, data integrity, and data security. • Performs routine database administration functions including database capacity planning, pro-active performance monitoring and tuning, executing security procedures and backup and recovery processes. • Supports activities and acts as a member of and resource to various application development teams in the development, QA (Quality Assurance), and test/production environments. • Efficiently works with server administrators, application administrators, vendors and consultants. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or higher academic course of study. • Remains abreast of database advancements and offers recommendations for use of these technologies. Identifies and routinely uses the most effective and cost efficient best practices/technology to execute processes; continually evaluates their effectiveness and appropriateness. • Works closely with IT Security on special projects Qualifications Requirements/Education Bachelors Degree in Computer Science (CS), Computer Information Systems (CIS), Management Information Systems (MIS), a related field, or equivalent8 • 8 plus years of progressively more responsible Oracle database administration and design work experience. • In-depth knowledge and hands-on experience with: installation and maintenance of current or/and latest versions of relevant Oracle database software; • Experience supporting large-scale databases; expert knowledge and comprehensive application of advanced Structured Query Language (SQL) concepts including PL-SQL, database backup, and restoration methods/techniques; expertise in database modeling (logical/physical) and design; advanced knowledge of database administration and monitoring tools; demonstrated understanding of High Data Availability concepts and methods, specifically Oracle RAC, Oracle Replication and DR methodologies; • Requires excellent written and verbal communication; interpersonal, facilitation, presentation, quantitative, analytical, organizational and follow-up skills. • Have the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. • Documented record of delivering software engineering information which adds value to management decision making process. Demonstrated ability to understand and comply with all applicable regulatory and company operating procedures, processes, policies, and tasks. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: Knowledge of the Oracle Database security products will be considered an advantage. |E-mail this position Submit Resume or C.V.2012-05-16 19:44:03United StatesSt. Jude MedicalCalifornia13195CALos Angeles, CA28739040http://jobs.sjm.com/xml/28739040/jobUSASylmarProgrammer Analyst, Senior Job Requisition #: 13196 Date Posted: 05/15/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Sharepoint Administrator Working independently with rare managerial oversight and direction as a part of the Information Technology (IT) organization, creates and maintains business application systems. Performs all phases of systems and programming development and maintenance by preparing detailed specification from which programs will be written in support of the assigned project(s) or group(s). Works on large complex systems installations, including the development of system specifications and the resolution of complex systems and programming problems. Performs complex programming activities, system analysis; preparing specifications, testing strategies and documenting applications. Directs and performs all phases of systems design including costing. Performs analysis and recommends strategies, determines and develops technical solutions and mentors less experienced employees. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Initiates the planning, organizing, performing, coordinating and/or directing of database work. Performs technical studies. Remains abreast of and consults on business application system advancements. Identifies and routinely uses the most effective, cost efficient and best practices/technology to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of eight plus years of progressively more responsible systems analysis, design, programming and testing experience. A thorough knowledge of software systems architecture principles, as well as databases and procedural languages required. Demonstrated experience working on large or complex projects in a diverse team environment. Ability to translate client requirements into a feasible design solution. Comprehensive ability to use proper coding techniques and efficiencies, testing methodologies, with an understanding of the operating system. Demonstrated planning, organizational, interpersonal and communication skills. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. This includes bridging communication issues between technical areas and business areas for a full and complete understanding of expectations. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. Solid experience with SharePoint 2007 and 2010 administration and configuration. Deep understanding of the SharePoint platform, its application services and architecture. Have relevant experience with SharePoint design, architecture, availability, reliability and security for large environment. Broad knowledge of content management, knowledge management and collaboration concepts. Skillful in business analysis, project coordination, communication and documentation. Maintain smooth operation production and test SharePoint farms, including coordination with IT resources and business stakeholders. Responsible for tuning system performance, installing system wide software and patches. Provides backup and restore recovery. Develops and monitors system performance and trend Evaluate and determines source of problem and uses best judgment to correct them. Resolves and/or facilitates the resolution of problems effectively and efficiently including identifying their causes to prevent re-occurrence. Write or support efforts to generate and maintain technical documentation: user guides, application primers, systems and validation documents and systems Policies and Procedures. Maintain regular, reliable, and predictable attendance. Required to work after hour and weekend to complete projects and tasks if needed. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Must be a team player with excellent oral and written communication skills. Performs other essential functions and responsibilities as determined by the Company from time to time. |E-mail this position Submit Resume or C.V.2012-05-16 19:44:03United StatesSt. Jude MedicalCalifornia13196CASylmar, CA28739041http://jobs.sjm.com/xml/28739041/jobUSASylmarCo-op Job Requisition #: 13019 Date Posted: 05/01/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview The Co-op (i.e., Co-operative Education”) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the student’s university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses’ fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. 1) Good communication and teamwork skills for working with all levels of employment and outside vendors 2) Needs to know the basics of Word, Excel, and PowerPoint 3) Familiar with computer aid software such as Pro-engineering and Windchill 4) Knowledge of drafting techniques and tool design 5) Familiar with product life cycle programs (Teamcenter) 6) Proactive and willing to learn new things; Not afraid of new challenges 7) Ability to multi-task and switch to higher priority tasks with little notice |E-mail this position Submit Resume or C.V.2012-05-16 19:42:25United StatesSt. Jude MedicalCalifornia13019CASylmar, CA28738983http://jobs.sjm.com/xml/28738983/jobUSAIrvineAssembler - 3rd Shift Job Requisition #: AF13883 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 3rd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13883CAIrvine, CA28634580http://jobs.sjm.com/xml/28634580/jobUSAIrvineAssembler - 2nd Shift Job Requisition #: AF13884 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 2nd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13884CAIrvine, CA28634579http://jobs.sjm.com/xml/28634579/jobUSASunnyvaleEngineer, Senior Software Job Requisition #: 12499 Date Posted: 04/13/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Sylmar, CA. Job Overview Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as Development Engineering, IT Engineering, System Engineering, Test Engineering, and/or related areas. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software specifications as well as the troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs technical studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. A demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks is also required. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Specialized experience and/or relevant coursework related to the software applications, programs, and processes. Academic or in-house courses in project management, leadership, training, TQM, and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-05-11 18:45:08United StatesSt. Jude MedicalCalifornia12499CASunnyvale, CA28634552http://jobs.sjm.com/xml/28634552/jobUSASylmarMicrobiologist, Staff Job Requisition #: 13130 Date Posted: 05/09/2012 Category: Microbiology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs a range of specialized duties in the Microbiology Lab to support sterilization validation activities, verify clean-room and environmental systems, and verify biocompatibility of materials. Work requires application of theoretical principles, evaluation, ingenuity and creative/analytical microbiological techniques acquired in a recognized four-year or more course of specialized study. Evaluates results and determines future courses of action to resolve problems. Exercises an appropriate level of independent technical judgment in planning, organizing, performing and coordinating assignments: leads tasks, projects, and microbiology programs; monitors performance and reports status to manager. Work is reviewed for soundness of judgment and overall adequacy/accuracy. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Assures that quality of services meets internal and external customer requirements. Remains abreast of all applicable advancements in field of specialty. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective cost efficient and best practices to execute processes. Requirements/Education: Bachelor of Science degree Microbiology or a related academic field. A minimum of three plus years of progressively more responsible work experience in the pharmaceutical or medical device industry; experience with environmental monitoring, and materials biocompatibility testing. Demonstrated research and investigative skills. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering microbiological information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, work processing, database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement, and various technical applications as noted above. Experience in a regulated medical industry. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:43United StatesSt. Jude MedicalCalifornia13130CASylmar, CA28574457http://jobs.sjm.com/xml/28574457/jobUSASylmarProgrammer, Senior Job Requisition #: 13168 Date Posted: 05/09/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working without appreciable direction, provides ongoing support to all new and existing MIS operating systems. Develops advanced requirements, workflow and systems analysis. Corrects complex programming errors, prepares operating instructions, compiles documentation of program development, and analyzes system capabilities to resolve questions of program intent, output requirements, input data acquisition, programming techniques, and controls. Requirements/Education: Bachelors Degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of eight plus years of progressively more responsible experience with operating systems and databases, including demonstrated experience with C, C++, Visual Basic, Java, MSAccess, Oracle or UDB is highly desirable. (E-commerce applications include.ASP, NT, Visual Basic, SQL Server). Extensive technical knowledge; utilizes very complex computer operations (i.e., advanced programming in 3rd and 4th generation languages, relational databases, and operating systems) and advanced features of software packages (i.e., word processing, spreadsheet, graphics, etc.). Understanding of proper coding techniques, efficiencies and testing requirements. Understanding of job control language, the operating system and file access methods. Proficient in debugging techniques and technical problem analysis, SAS programming and expertise with UNIX, Windows, OS. Demonstrated planning, organizational, interpersonal and communication skills. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. This includes bridging communication issues between technical areas and business areas for a full and complete understanding of expectations. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-05-09 18:01:15United StatesSt. Jude MedicalCalifornia13168CASylmar, CA28574453http://jobs.sjm.com/xml/28574453/jobUSASylmarDirector, Regulatory Compliance and Patient Data Services Job Requisition #: CRMD42712 Date Posted: 05/07/2012 Category: Quality Assurance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working independently and in consultation with executive Quality Assurance management, has primary management responsibility directly or through lower management levels for the compliance of company facilities and related activities with applicable domestic and international regulations; works with U.S. Food & Drug Administration (FDA) and parallel agencies to address regulatory compliance activities and issues. Recommends, interprets, and implements corporate division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems; ensures employee compliance with such policies, practices, and procedures. Assures that quality of services meets internal and external customer requirements. Maintains a safe working environment and a strong customer focus. Exercises judgment in planning and organizing work; monitors performance and reports status. Sets goals, ensures that they are met and is responsible for continuous process improvement. Uses best business practices to ensure success in areas of responsibility. May be responsible for processes across organizational lines. Requirements/Education: A Bachelors Degree in physical/natural sciences, environmental engineering, or a related academic field. A minimum of at least ten plus years of progressively more responsible regulatory experience including experience with medical devices. Expert working knowledge of domestic and international regulations relative to the medical device industry. A demonstrated ability to analyze and evaluate technologically complex devices. A minimum of four plus years of demonstrated experience at a supervisory/managerial level is typical. Seasoned judgment acquired through wide experience and cross-organizational assignments. Ability to work cooperatively/productively with others. Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations. Requires highly developed leadership skills/people-management experience sufficient to assume the complex range of personnel issues inherent in this position. Must be adept at delegation, follow-up, and team building. Comprehensive verbal and written analytical/problem solving, communication, negotiation, interpersonal, training and presentation skills are essential. Documented record of delivering information that adds value to managements decision making process. Must have a demonstrated working knowledge of frequently used personal computer programs and applications used in relevant regulatory processes. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. A comprehensive understanding of cardiac rhythm management technology. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc., are preferred. |E-mail this position Submit Resume or C.V.2012-05-07 18:22:22United StatesSt. Jude MedicalCaliforniaCRMD42712CASylmar, CA28478355http://jobs.sjm.com/xml/28478355/jobUSASylmarScientist, Staff Job Requisition #: 13133 Date Posted: 05/04/2012 Category: Research Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Works independently under broad supervision to provide strategic support in the design, construction, and testing of technology for implantable medical devices such as cardioverter defibrillators. Accountable for project ownership and management of new products from conception through qualification builds and into manufacturing. Identifies scientific problems and applies scientific principles to the solution of a broad range of complex problems. Conducts Research & Development (R&D) efforts involving theoretical and experimental study, conception and planning of clinical objectives and coordination and direction of clinical efforts. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing assigned technical work. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Continuously works towards work product/process improvement. Consults other departments in the field of technical expertise. Requirements/Education: Requires a Bachelors Degree in chemistry, physics, a related field, or equivalent. Typically a minimum of ten plus years research experience in cardiovascular medicine or related fields. Applies an extensive technical expertise and/or a thorough specialized knowledge at the forefront of the biomedical profession; applies, develops, and promotes advanced concepts and practices; required to perform as a recognized authority in the medical device profession. Requires the demonstrated ability to analyze and evaluate technologically complex devices; comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to work cooperatively and productively with others. Demonstrated ability to understand and comply with applicable U. S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet skills, word processing, data base management, and other relevant clinical applications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Demonstrated knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems is desired. |E-mail this position Submit Resume or C.V.2012-05-04 19:21:22United StatesSt. Jude MedicalCalifornia13133CASylmar, CA28440756http://jobs.sjm.com/xml/28440756/jobUSASylmarClinical Data Coordinator II Job Requisition #: 13147 Date Posted: 05/04/2012 Category: Compliance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, is responsible for ensuring the integrity of clinical data both in the clinical database as well as in the clinical files. Responsible for entering, reviewing, verifying, modifying and organizing incoming clinical data. Identifies potential issues that could affect the quality of clinical data and forwarding to appropriate personnel. Provides administrative support for the clinical study as needed and for identifying solutions to continue to improve efficiency and quality in the data management process. Responsible for clarifying missing data with external customers. Exercises basic judgement in planning, organizing and performing work. Assures that quality of services meets internal and external customer requirements. This position will have primary responsibility for assigned studies with a basic knowledge of all studies managed by clinical data group. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of two years of demonstrated experience as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes. Experience with the Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to clinical data management and to the clinical trial process. Demonstrated competence in English spelling, grammar and punctuation, including the ability to successfully pass a reading comprehension pre-employment examination. Requires a demonstrated knowledge of the practices and procedures of the function, company products, polices and programs. Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously. Demonstrated interpersonal skills, including the ability to listen, resolve routine to moderately complex problems, deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators. Must possess demonstrated keyboard and personal computer skills (experience with Microsoft Office including Excel, Word or equivalent applications required), including the ability to pass a 10 key assessment examination. Desired Requirements: Associate Degree in a Computer Science, Health Science, a related curriculum, plus experience in the biotech, bio-instruments or medical devices industries. |E-mail this position Submit Resume or C.V.2012-05-04 19:20:16United StatesSt. Jude MedicalCalifornia13147CASylmar, CA28440701http://jobs.sjm.com/xml/28440701/jobUSASylmarMachinist, Senior Job Requisition #: 12910 Date Posted: 05/04/2012 Category: Tachy Product Development Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Under limited supervision and in support of the manufacture of medical devices: constructs, maintains, calibrates, repairs, sets up and operates manual machine shop equipment; programs, sets up and operates Computer Numerical Control (CNC) equipment. Operates a variety of machine tools and works with designers and engineers to develop or modify tooling. Works from relatively complex blueprints, engineering specifications/diagrams and general engineering instructions to set-up and execute work assignments; checks work using precision inspection instruments and devices. Requirements/Education: High School diploma or equivalent. Typically a minimum of six or more years of relevant manual and CNC machining experience. Demonstrated knowledge and understanding of all aspects of the job, including the ability to set up and operate specialized and sophisticated machining equipment. Requires the demonstrated ability to read complex blueprints in order to determine the best method for manufacturing various components as well as the ability to use, operate, and apply a range of precision inspection instruments and devices, e.g., micrometers, calipers, height gages, etc. Demonstrated verbal and written communication, interpersonal, organizational and basic math skills. Must be able to perform functions utilizing machines and equipment requiring correctable vision, including color discrimination, and be able to demonstrate effective hand/eye coordination at an acceptable level of proficiency in all process certifications. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: AA degree in Mechanical Technology, equivalent trade school/military training, or comparable related experience in biomedical field. |E-mail this position Submit Resume or C.V.2012-05-04 19:20:09United StatesSt. Jude MedicalCalifornia12910CASylmar, CA28440687http://jobs.sjm.com/xml/28440687/jobUSASylmarBusiness Systems Analyst, Senior Job Requisition #: 12717 Date Posted: 05/04/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Working without appreciable direction, provides ongoing application support to SJM CRMD users in order to solve business application related issues. This includes the training of system users in the different major business applications; works across CRMD to research and implement software applications that can improve business processes and in modifying current systems to accommodate changing business requirements. Identifies and routinely uses most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field of expertise. Requirements/Education: Bachelors degree in Information Systems, Computer Science or equivalent degree in a pertinent discipline required and 6 plus years of systems experience, including ERP, PDM, MES. Extensive knowledge of financial systems, financial analysis and sales analysis and reporting, ERP system applications , and/or Manufacturing / Engineering systems, and/or Patient Device Tracking systems and/or Device Master Record or Device History Record reporting systems. Must also possess the ability to understand, document , and enhance manufacturing business processes. Must be highly literate in terms of how mainframe, network and desktop systems operate. A relevant advanced degree is desired. Comprehensive verbal and written analytical/problem solving, communication, interpersonal and presentation skills required sufficient to conduct advanced discussions, interviews, negotiations, and give thorough presentations. Must be able to handle multiple projects simultaneously. Comprehensive personal computer skills including spreadsheet, word processing and data base management capabilities (including, but not limited to, such applications as Access, Excel and Word) are required. Team Center (Siemens-TCE) SQL Development Access Database Development .Net Development |E-mail this position Submit Resume or C.V.2012-05-04 19:19:57United StatesSt. Jude MedicalCalifornia12717CASylmar, CA28440683http://jobs.sjm.com/xml/28440683/jobUSASylmarAdministrative Assistant, Senior Job Requisition #: 13132 Date Posted: 05/03/2012 Category: Administrative Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under limited supervision, organizes, plans and performs a variety of secretarial, clerical, and administrative support duties, such as (but not limited to): receiving/screening/directing phone calls/faxes/e-mails; making travel arrangements; scheduling appointments; arranging meetings; preparing correspondence/reports/documents/presentations; collecting/distributing data; and maintaining paper/electronic filing systems. Takes initiative to improve work product and processes. May be accountable for reviewing work of less experienced employees for quality and content. Adapts existing work methods to different situations. Can resolve unusual, nonstandard problems; refers only significant deviations from approved policy/practice to supervisor or more senior level personnel for resolution. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of five or more years of progressively more responsible office clerical experience. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Incumbents are required to work cooperatively and productively with others. Demonstrated organizational skills, attentiveness to detail, and the ability to work under general supervision is required. Must be adept at handling multiple assignments in a timely manner while meeting assigned deadlines. Must also have demonstrated verbal and written communication, interpersonal, organizational and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: An Associates degree in Business Administration, a related field, or equivalent. Previous secretarial experience to department management. Experience in the biotech, bio-instruments, or medical devices industries are also preferred. Previous experience using Microsoft Outlook and the demonstrated ability to use Outlook Scheduler a plus. |E-mail this position Submit Resume or C.V.2012-05-03 20:20:57United StatesSt. Jude MedicalCalifornia13132CASylmar, CA28411520http://jobs.sjm.com/xml/28411520/jobUSASylmarCo-op Job Requisition #: 13022 Date Posted: 05/02/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview The Co-op (i.e., Co-operative Education”) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the student’s university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses’ fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. 1) Good communication and teamwork skills for working with all levels of employment and outside vendors 2) Needs to know the basics of Word, Excel, and PowerPoint 3) Familiar with computer aid software such as Pro-engineering and Windchill 4) Knowledge of drafting techniques and tool design 5) Familiar with product life cycle programs (Teamcenter) 6) Proactive and willing to learn new things; Not afraid of new challenges 7) Ability to multi-task and switch to higher priority tasks with little notice |E-mail this position Submit Resume or C.V.2012-05-02 18:55:02United StatesSt. Jude MedicalCalifornia13022CASylmar, CA28333006http://jobs.sjm.com/xml/28333006/jobUSASylmarEngineer II, Design Assurance Job Requisition #: 13072 Date Posted: 05/02/2012 Category: Quality Assurance Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, prepares and coordinates the qualification testing of potential new products, accessories and components. Provides training to Quality Control Engineers and Inspectors, and to Manufacturing Engineers for the transference of the product into production. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: A Bachelor of Science Degree in Mechanical Engineering or in a physical science, a related field, or equivalent. Typically a minimum of three plus years of progressively more responsible work experience in a high technology manufacturing environment. Broad technical knowledge of the design assurance profession knowledge; expertise in one or more relevant specialties. Familiarity with commodity and off-the-shelf electronic components. Basic familiarity with industry-wide standards for qualifying components and sub-assemblies. Demonstrated experience in the use of common laboratory-type equipment. Demonstrated verbal and written analytical/problem solving, communication, interpersonal and presentation skills. Ability to work well with others in various disciplines and at various sites. Demonstrated personal computer skills including spreadsheet, word processing, and data base management capabilities. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Experience in a regulated medical industry. |E-mail this position Submit Resume or C.V.2012-05-02 18:53:59United StatesSt. Jude MedicalCalifornia13072CASylmar, CA28332985http://jobs.sjm.com/xml/28332985/jobUSASylmarManager, Senior Product Marketing Job Requisition #: 12263 Date Posted: 05/01/2012 Category: Marketing Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Acting independently and within broad policy, has primary management responsibility for developing comprehensive and integrated portfolio and commercial strategies within core CRM markets and product segments. Responsible for early phase product planning activities including business justification, executing and managing implementation of commercial strategies and development and execution of product commercialization plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible experience in a Marketing capacity, with focus on strategic product planning and commercial execution. Requires highly developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential; Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2012-05-02 18:53:58United StatesSt. Jude MedicalCalifornia12263CASylmar, CA28332984http://jobs.sjm.com/xml/28332984/jobUSAIrvineQuality Control Inspector Job Requisition #: AF13852 Date Posted: 05/01/2012 Category: Quality Control Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Quality Control Inspector. The successful candidate in this position will perform a wide variety of functions, including visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures and be able to utilizing measuring equipment and procedures. Impact this role will have within the AF division: • Perform visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures. • Work closely and cooperatively with area Supervisor or Quality Engineer to ensure quality checkpoints are in place as part of the production process and partner with quality work groups on day-to-day problem solving related to product production and process improvement. • Communicate with Quality/Manufacturing Engineering and Management on quality issues. • Practice Good Manufacturing Practices (GMPs) including documentation practices and proper gowning techniques. • Review device history records for sign-off of completion of operation and accuracy. • When applicable, initiate and complete nonconforming material reports to ensure appropriate disposition of nonconforming material. • Provide and complete required GMP, Issue resolution and task specific training. • Assist in the implementation of changes required. • Support quality inspection functions of other manufacturing cell product lines as needed. Required Qualifications: • High School diploma • Prior experience with Quality Control in a manufacturing environment. • Execute test protocols, final inspection testing under engineer supervision. • Be able to communicate ideas effectively both verbally and in writing and to facilitate change. • Working knowledge of Good Manufacturing Practices (GMPs). • Excellent interpersonal and communication skills are essential for success. • Must be able to work well with others in a team environment and have a hands-on approach to problem solving. • Must possess the ability to handle multiple tasks with attention to detail. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience in an Inspector role. • Prior experience in the medical device industry. |E-mail this position Submit Resume or C.V.2012-05-01 19:14:51United StatesSt. Jude MedicalCaliforniaAF13852CAIrvine, CA28305015http://jobs.sjm.com/xml/28305015/jobUSASylmarManager, Software Development Job Requisition #: PR8006A Date Posted: 04/27/2012 Category: Software Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Software Engineering Manager. Lead team of engineers in the testing of applications software for use in cardiac pacing and associated medical systems products, including responsibility for senior-level engineering services involving the specification, implementation and testing of software incorporating graphical user interface designs, embedded real-time applications, test and simulation features, and device subsystems requirements; the formulation of test strategies; the creation of test design documents; the implementation and execution of manual, interactive and automated test processes; the initiation of value-added process improvements for software verification procedures; the direction of verification, validation, configuration management and defect tracking activities; and the use of requirements software tools (including ClearCase, ClearQuest and DOORS), as well as Java- based programs, Visual Studio and graphical user interface (GUI) applications. Either U.S. or foreign Master’s degree in computer engineering or management, and 1 year of experience in the occupation or in a software developer, programmer, programmer trainee or related capacity; or U.S. or foreign Bachelor’s degree in computer engineering or management, and 5 years of progressively responsible experience in the occupation or in a software developer, programmer analyst, programmer trainee or related capacity. |E-mail this position Submit Resume or C.V.2012-04-27 19:58:25United StatesSt. Jude MedicalCaliforniaPR8006ACASylmar, CA28240313http://jobs.sjm.com/xml/28240313/jobUSASunnyvaleSr. Software Development Engineer Job Requisition #: AF13663 Date Posted: 04/27/2012 Category: Software Engineering Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Senior Software Engineer to meet our standard product development needs as well as increase our ability to deliver integrated hardware and software solutions to meet our project specific requirements. Impact this role will have within the AF division: • The Senior R&D Software Engineer designs and develops application software for RF ablation systems. • This role writes product requirement documents, designs, develops code, unit tests and helps out the verification team. Required Qualifications: • Bachelor’s degree in Computer Science, Computer or Electrical Engineering • 7 + years hands-on development experience with real-time embedded hardware, software design and development, and programming experience in C/C++, QT, Object Oriented programming with knowledge of Hardware interfaces and microprocessors • Experience with Linux, or other real time operation system, OS kernel module, device driver development • Familiarity with software configuration and software defect tracking systems • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks • Effective verbal and written communication skills to interact with associates at all levels of the organization, vendors and other SJM entities • Adaptability to frequent change in the work environment • Ability to prioritize responsibilities and ensure deadlines are met • Proficient working knowledge of MS Word, Outlook, PowerPoint, Excel and Project • Experience with 3D image processing, registration and rendering software design, Wireless protocols • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Masters degree in Computer Science, Computer or Electrical Engineering • Experience with RTOS, debugging tools and good software development processes • Working knowledge of entire software development and test cycle with at least one complete FDA regulated medical device product development cycle. Knowledge of applicable international regulations and standards (QSR, ISO 13485, ISO14971) • Formal training in Program/Project Management or Program Management Professional Certification |E-mail this position Submit Resume or C.V.2012-04-27 19:56:25United StatesSt. Jude MedicalCaliforniaAF13663CASunnyvale, CA28240250http://jobs.sjm.com/xml/28240250/jobUSASylmarEngineer II, Software (requirements) Job Requisition #: 12775 Date Posted: 04/23/2012 Category: Software Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Our Software Requirements Engineering team within the Cardiac Rhythm Management Division located in the suburbs of Los Angeles, CA is seeking talented and skilled Requirements Engineers. The successful candidate for this position will: Gather, analyze, and document detailed software requirements for external instruments supporting implantable cardiac devices, and/or remote patient monitoring and patient care management systems for these devices Write detailed software requirements specifications that describe use cases, functional, user interface, performance, data, and interface requirements Analyze trade-offs between system and clinical requirements, hardware and software architectural constraints, technical capability, and project cost / schedule Perform requirements traceability to system-level requirements, and participate in system / software risk assessment activities Cultivate strong customer and interdisciplinary relationships to acquire product requirements and share information with others to validate assumptions Apply software engineering principles and techniques to solve complex technical problems, identifying potential areas of concern and improvements to products and processes Create and update process definition documentation, including process descriptions, technical specifications, and process models Support the creation of documents necessary for submission to regulatory agencies Requires a BS/MS Engineering-related (EE, CS, or BioMedical) degree and 3+ years of direct experience in requirements engineering discipline. Qualified applicants must have excellent verbal, written, comprehension, analytical, presentation and interpersonal skills. Applicants should have theoretical knowledge and practical experience in software engineering and requirements elicitation methodologies. Additionally, experience in one or more of the following areas is highly desirable: • Cellular communications technology • Database modeling / relational databases • High fidelity UI mockup creation using Fireworks and/or Dreamweaver • Requirements and/or architectural modeling techniques (e.g. UML) • Requirements management and defect tracking tools (e.g. DOORS, Clearquest) • Working with Class III cardiac medical devices • Software lifecycle processes in a highly regulated environment (FDA, ISO, and other regulatory bodies) |E-mail this position Submit Resume or C.V.2012-04-23 20:19:12United StatesSt. Jude MedicalCalifornia12775CASylmar, CA28080470http://jobs.sjm.com/xml/28080470/jobUSASylmarReimbursement Specialist Job Requisition #: 13075 Date Posted: 04/23/2012 Category: Reimbursement Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, collaborates with others to support internal and external customers for Reimbursement. Supports department in reimbursement clinical trial budgetary process. Insures that Clinical Trial compensation processes adhere to Company policies and meet compliance standards. Responsible for assisting sites in the appeal process, and other related matters utilizing a very specialized knowledge of the Medicare Reimbursement procedures as well as private payers. Conducts data analysis utilizing Medicare data, procedure codes, hospital payment codes and other claims data. Promotes the process of continuous quality improvement and applies clinical principles to the solutions for technical issues. Exercises considerable judgment in planning and organizing work. Requirements/Education: Bachelors Degree in Business Administration, Bachelors Degree inof Science, or Nursing Degree, or equivalent academic discipline. A minimum of three years of analytical experience involving coverage policies, procedures, and regulations, including but not limited to: Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals. Demonstrate a working knowledge of coding, Diagnostic Related Group (DRG) assignments, Ambulatory Payment Classification (APC) categorization and process. Demonstrated knowledge of federal, state and industry rules and regulations governing technical aspects of reimbursement and compliance. National and Local Coverage Policies (NCD and LCD) Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, multi-task, prioritize such task, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential. Demonstrated discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet skills, word processing, database management and other relevant applications. Desired Requirements: Previous related experience in reimbursement for medical device, or pharmaceutical company. Registered nurse, legal, clinical research associate experience desired |E-mail this position Submit Resume or C.V.2012-04-23 20:17:54United StatesSt. Jude MedicalCalifornia13075CASylmar, CA28080425http://jobs.sjm.com/xml/28080425/jobUSAIrvineProduct Development Engineer II Job Requisition #: AF13842 Date Posted: 04/17/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Product Development Engineer II to develop design concepts of disposable medical devices for the treatment of cardiac arrhythmias. The engineer will partner with other product development Engineers and perform the necessary developments and validations to advance the state of art designs of products requested from the customers. The engineer will create design history file documentation and write protocols and test reports for verification and validation testing. The engineer will also identify key design concepts for improving sub-assembly and final assembly of finished catheters. In addition, the engineer will assign prototyping and testing tasks to the R&D technicians to maintain continuous flow of product delivery to Advanced Manufacturing and Production. Impact this role will have within the AF division: • Communicates and demonstrates feasibility to customers and management focusing on treatment of cardiac arrhythmias. Evaluation of technologies should be based on the ability of the technology to provide a clinical utility to the user. • Independently focuses on design improvements having merit and meeting the robustness of design for manufacturability. • Maintains workflow with all of the necessary processes pertaining to Change Requests to effectively reduce multiple design changes that tend to slow the progression of each project. • Addresses issues and communicates with interdepartmental personnel to foster a complete understanding of the project scope and direction before releasing the design to the next responsible individual or department. • Identifies key attributes for advancing the state of the art of related products to the core business. Required Qualifications: • Requires Bachelor’s degree • 3+ years as a product development engineer with experience in all aspects of development activity of disposable medical devices • Demonstrated success in bringing new products from concept to market • Knowledge of design controls as well as FDA Quality System Requirements • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Bachelor’s degree in Mechanical Engineering • Familiar with ISO standards, GMP and GLP procedures. • Have high level understanding of design analysis and root cause failure analysis procedures for disposable catheters, preferably electrophysiology catheters. • Experience with design and processes involved in catheter manufacturing including extrusion and injection molding. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:09United StatesSt. Jude MedicalCaliforniaAF13842CAIrvine, CA27948908http://jobs.sjm.com/xml/27948908/jobUSASylmarDevice Monitoring Representative Job Requisition #: 12929 Date Posted: 04/13/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under close and direct supervision on defined work assignments and/or usually following established procedures, answers technical and informational questions. Troubleshoots and resolves website problems and transmissions of patient data. Works in a call center work environment, exercising basic customer service skills in responding to remote patient monitoring inquiries from physicians, health care professionals, field staff, and patients. Responds accurately, promptly, and effectively to such inquiries and provides the basic clinical and technical interface between patients, the remote care medical community, and various Cardiac Rhythm Management Division (CRMD) departments. Proactively questions callers to identify and collect information to answer relatively complex inquiries regarding technical issues and/or complaints, as well as adverse events. Triages calls and may forward them to other CRMD personnel for further assistance when appropriate. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve website navigation and troubleshooting, patient transmitter set-up, and product information for remote care products; usually refers more complex problems to supervisor or more senior level personnel. Remains abreast of remote care advancements within SJM and industry. Routinely uses the most effective, cost efficient and best practices to execute processes. Requirements/Education: High school diploma or other specialized training/equivalent related experience. Typically a minimum of four or more years of progressively more responsible experience in a customer service, product support, IT, telecommunications or related role. Complete knowledge and understanding of all aspects of the job; requires a thorough knowledge of the practices and procedures of the function, company products, polices and programs. Demonstrated organizational skills, attentiveness to detail and the ability to work under close and direct supervision on defined work assignments is required. Incumbents are required to establish/maintain good working relationships and be able to work cooperatively and productively with others. Must be adept at handling multiple assignments in a timely manner while meeting assigned multiple projects/assignments. Must also have demonstrated verbal and written communication, interpersonal, facilitation, presentation, organizational, and basic math skills. The comprehensive ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to use discretion and handle sensitive/confidential information. Demonstrated proficiency in operating a personal computer; the ability to pass a 10 key assessment examination. Must be proficient in using various PC-based software packages including spreadsheet, word processing, database management, and specialized applications. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. This position requires 24/hr., 7 day per week on-call availability. Desired Requirements: Fluently bilingual or multilingual in other languages is preferred. A healthcare, IT or telecommunications background is helpful. Experience in a technical support role to the medical device industry is preferred. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:53United StatesSt. Jude MedicalCalifornia12929CASylmar, CA27883027http://jobs.sjm.com/xml/27883027/jobUSASunnyvaleRF Characterization Engineer Job Requisition #: 12377 Date Posted: 04/13/2012 Category: Electrical Engineering Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a hands-on technical RF Characterization Engineer to work on RF characterization from IC to system level on implantable biomedical products. These implantable pacemakers and implantable defibrillators save lives and provide therapy for serious medical conditions. Our devices are complex, low-power, embedded systems and include custom analog, digital, and mixed signal ICs, hybrids, and discrete components. The successful person in this role will have a good RF background with hands-on RF characterization experience and good breadth of electrical engineering knowledge. The RF Characterization Engineer will comprehensively analyze designs, create appropriate characterization test plans with rationale for choices, critically evaluate results, and trouble-shoot through challenging problems. This person will also work closely with other cross-functional groups such as Design, ATE, Firmware, Clinical Systems, and Manufacturing. Required Skills: • MSEE with at least 2 years RF systems experience or BSEE with at least 3 years RF systems experience • Theoretical and practical understanding of RF at system level • Hands on RF characterization including use of RF bench equipment • Strong technical analysis and troubleshooting skills for products containing RF, analog / digital ICs, discrete components, embedded systems • Excellent interpersonal and communication skills with ability to multi-task • Track record working collaboratively across functions in successful product development • Demonstrated ability to organize, analyze, document, prepare for characterization test plans, reviews, and reports • Ability to pick things up quickly • Motivated to learn about and ability to lead biomedical product development Desired Skills: • RF IC and RF Systems experience including ATE and bench equipment • Programming skills in C, LabWindows CVI |E-mail this position Submit Resume or C.V.2012-04-13 20:07:09United StatesSt. Jude MedicalCalifornia12377CASunnyvale, CA27882978http://jobs.sjm.com/xml/27882978/jobUSASunnyvaleMixed Signal IC Design Engineer Job Requisition #: 12378 Date Posted: 04/13/2012 Category: Electrical Engineering Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mixed Signal IC Design Engineer We are seeking a talented and versatile IC designer to be a part of our Integrated Circuit Development organization. Our team designs ultra-low power mixed-signal IC’s for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The successful person in this role will have a solid mastery of mixed-signal IC design, with breadth and depth of knowledge across digital and analog design. In this role, the engineer will work closely with other members of the Analog and Digital Design groups, and play a key role in growing our mixed-signal design, and system-on-a-chip development capability. Required Skills: - Solid background in analog IC design, knowledge of MOS device physics and design experience with common building blocks such as op amps, bias generators, bandgap references, switched capacitor circuits, etc. - Strong knowledge of simulation test bench development for mixed-signal (analog and digital) simulations, excellent simulation and debug skills, and working knowledge of mixed-signal testing. - Experience with Modelsim, NC-Verilog, VCS or similar digital logic simulators. - Experience with Verilog, C, and/or System Verilog. - Knowledge of the basic elements of writing synthesizable Verilog RTL code, including simple state machines, hardware register interfaces to an embedded MCU, and hierarchical design - Working knowledge of Matlab is desired. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements Education and Experience Requirements: BSEE or equivalent degree required, MSEE or equivalent preferred At least 6 years industry experience in IC design |E-mail this position Submit Resume or C.V.2012-04-13 20:07:09United StatesSt. Jude MedicalCalifornia12378CASunnyvale, CA27882979http://jobs.sjm.com/xml/27882979/jobUSASunnyvaleSenior RF Software/Hardware Engineer Job Requisition #: 12376 Date Posted: 04/13/2012 Category: Software Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a talented and versatile RF Engineer with strong software skills to be a part of our RF Telemetry Hardware organization. Our team is responsible for the RF hardware design for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The RF telemetry system provides a critical communication link between those implantable devices and external programmers and interrogators. The successful person in this role will have a strong background in firmware or software design, and a solid understanding of RF engineering. In this role, the engineer will work closely with other members of the RF and electrical system design groups, and play a key role in growing our RF telemetry capability. Responsibilities: - Software and Firmware design for RF hardware system design and characterization for implantable and external medical devices - Create software for RF system prototypes for output power measurements, optimization, tuning, sensitivity and parametric measurements. - RF laboratory measurements, including: o Measurement of small antenna performance in TEM cells o Evaluation of small inductive/magnetic loop antennas. - Develop, maintain, and support characterization firmware for use in RF system development - Interface with customers, vendors, and other department functions (manufacturing, mechanical designers, etc). Required Skills: - BSEE (MSEE preferred) and at least 5+ years of experience in software and/or firmware design, with a strong background in RF - Programming experience in C, C++, and LabWindows CVI - Firmware programming experience on embedded microcontrollers - Proven ability to develop structured, revision-controlled code used by various other groups/organizations - Excellent RF laboratory skills, including the use of spectrum analyzers, network analyzers, power meters, slide-screw tuners, test automation, etc. - Familiar with BER, polarization, free space loss, S-parameters, Smith Charts, and other RF measurements and performance metrics - Ability to grow and adapt to other work functions. - Capable of independent work as well as part of small teams. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements |E-mail this position Submit Resume or C.V.2012-04-13 20:07:08United StatesSt. Jude MedicalCalifornia12376CASunnyvale, CA27882976http://jobs.sjm.com/xml/27882976/jobUSASylmarTechnical Services Engineer Job Requisition #: 12932 Date Posted: 04/12/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, is primarily responsible for providing clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff. Provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments. •Lead several small teams in developing and testing technical tools and projects, including establishing ROI for projects, project plans, requirements, and test cases. •Provide cross-functional input to various product development teams on field issues and enhancement requests. •Attend advanced training sessions with product development engineering, then develop and present training for the RCTS team. Support questions from the team on an ongoing basis, as a subject matter expert on the remote care products, researching questions or testing behaviors, as needed. •Periodically travel to support customer programs. Requirements/Education: Bachelor of Science Degree in electronic engineering, biomedical engineering, or a related engineering field. A minimum of four plus years experience in a technical support role to the medical device industry, including relevant desired experience in the cardiac pacing industry. •Outstanding leadership skills, ideally with strong management potential. •Communication skills (i.e.: written, verbal, and through presentations). Versatility to be able to communicate effectively and patiently with management, elderly patients, clinicians, field personnel, and various technical and non-technical teams. •4 or more years of engineering experience. •Knowledge of databases would be a strength. •Experience in a cross-functional engineering role and/or a customer-facing role is preferred. •Excellent aptitude for learning complex systems, retaining information, and establishing creative troubleshooting techniques. |E-mail this position Submit Resume or C.V.2012-04-12 20:21:08United StatesSt. Jude MedicalCalifornia12932CASylmar, CA27852709http://jobs.sjm.com/xml/27852709/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12699 Date Posted: 04/11/2012 Category: Technical Services Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. Candidate that can work in a fast-paced environment, with attention to detail, meet deadlines, and has excellent organizational skills. Knowledge in FDA CDRH regulations a plus. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:32United StatesSt. Jude MedicalCalifornia12699CASunnyvale, CA27828034http://jobs.sjm.com/xml/27828034/jobUSASylmarEngineer, Principal Human Factors Design Job Requisition #: 12778 Date Posted: 04/10/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Engineer, Prin Human Fact Desi Summary Working independently without appreciable managerial oversight and direction, creates, develops, and leads teams that execute human factors engineering process for critically important products and product lines with the purpose of meeting divisional growth objectives. Plans, leads and conducts customer and competitive research to identify, prioritize/develop new projects, create detailed usability improvement plans, conceptual design, select/manage external usability design resources, and lead internal and external development resources to conduct customer usability research, conceptual design development, usability testing, interaction design and usability validation. In addition, is responsible for usability initiatives across product/organizational lines, and for training staff members about relevant usability theory, resources, and technology. Primarily supports one or multiple major programs and may advise other multiple efforts. Considered the Human Factors Departments technical product or protocol expert. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year or more of academic studies. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Applies advanced usability improvement principles to the evaluation and solution of complex product design problems. Remains abreast of and consults on usability improvement advancements. Creates and trains others in the use of the most effective, cost efficient and best usability related processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in the planning, organizing and performing work; monitors own and project teams performance and reports status to management and program team. Assures that quality of services meets or exceeds internal and external customer requirements. Qualifications Requirements/Education: Bachelors Degree in Psychology, Human Factors, Engineering, and Marketing, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience with the design of software for complex applications. Requirements include an in-depth knowledge and experience of: human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with research & development teams; customers, trends, governmental factors and emerging research and technologies affecting product usability. A qualified record of implementing new processes to existing human factors and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in human factors engineering, cognitive or experimental psychology, or in a field related to human-computer interaction. Experience with the cardiac pacing and defibrillation device market is also highly desirable. Academic or in-house courses in project management, leadership, training, continuous improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:25United StatesSt. Jude MedicalCalifornia12778CASylmar, CA27828017http://jobs.sjm.com/xml/27828017/jobUSASunnyvaleEngineer, Principal Human Factors Design Job Requisition #: 12779 Date Posted: 04/10/2012 Category: Engineering Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Engineer, Prin Human Fact Design Summary Working independently without appreciable managerial oversight and direction, creates, develops, and leads teams that execute human factors engineering process for critically important products and product lines with the purpose of meeting divisional growth objectives. Plans, leads and conducts customer and competitive research to identify, prioritize/develop new projects, create detailed usability improvement plans, conceptual design, select/manage external usability design resources, and lead internal and external development resources to conduct customer usability research, conceptual design development, usability testing, interaction design and usability validation. In addition, is responsible for usability initiatives across product/organizational lines, and for training staff members about relevant usability theory, resources, and technology. Primarily supports one or multiple major programs and may advise other multiple efforts. Considered the Human Factors Departments technical product or protocol expert. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year or more of academic studies. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Applies advanced usability improvement principles to the evaluation and solution of complex product design problems. Remains abreast of and consults on usability improvement advancements. Creates and trains others in the use of the most effective, cost efficient and best usability related processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in the planning, organizing and performing work; monitors own and project teams performance and reports status to management and program team. Assures that quality of services meets or exceeds internal and external customer requirements. Qualifications Requirements/Education: Bachelors Degree in Psychology, Human Factors, Engineering, and Marketing, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience with the design of software for complex applications. Requirements include an in-depth knowledge and experience of: human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with research & development teams; customers, trends, governmental factors and emerging research and technologies affecting product usability. A qualified record of implementing new processes to existing human factors and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering software engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in human factors engineering, cognitive or experimental psychology, or in a field related to human-computer interaction. Experience with the cardiac pacing and defibrillation device market is also highly desirable. Academic or in-house courses in project management, leadership, training, continuous improvement (CI), and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-12 01:39:24United StatesSt. Jude MedicalCalifornia12779CASunnyvale, CA27828016http://jobs.sjm.com/xml/27828016/jobUSASylmarEngineer, Senior Hardware Design Job Requisition #: 12374 Date Posted: 04/11/2012 Category: Tachy Product Development Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview We are seeking a talented and versatile RF Engineer to be a part of our RF Telemetry Hardware organization. Our team is responsible for the RF hardware design for use in St. Jude Medical’s implantable pacemakers and defibrillators. These devices save lives and provide therapy for serious medical conditions. The RF telemetry system provides a critical communication link between those implantable devices and external programmers and interrogators. The successful person in this role will have a solid mastery of RF engineering, with breadth and depth of knowledge across electrical design. In this role, the engineer will work closely with other members of the electrical system design groups, and play a key role in growing our RF telemetry capability. Responsibilities: - RF hardware system design for implantable medical devices - Create RF circuit prototypes for output power measurements, sensitivity and parametric measurements. - RF laboratory measurements, including: o Measurement of small antenna performance in TEM cells o Evaluation of small inductive/magnetic loop antennas. - Performing studies, RF modeling, simulation and other forms of analysis to predict component, interconnect, system and board level performance and to optimize design around complex requirements. - Refine and execute methodologies to carry designs into production. - Interface with vendors for the purchase, evaluation and testing of components. - Interface with customers, vendors, and other department functions (manufacturing, mechanical designers, etc). Required Skills: - BSEE (MSEE preferred) and at least 5+ years of experience in RF design - Thorough understanding of RF components such as dual directional couplers, splitters, programmable attenuators. - Excellent RF laboratory skills, including the use of spectrum analyzers, network analyzers, power meters, slide-screw tuners, test automation, etc. - Experience in antenna matching and matching network design for a miniaturized radio. - Familiar with Link Budget Analysis, BER, Polarization, free space loss, S-parameters, Smith Charts, Modulation standards and Noise figure calculations. - Ability to work with mixed signal domains in creating PCB and subassemblies for small production runs. - Ability to grow and adapt to other work functions. - Capable of independent work as well as part of small teams. - Excellent verbal and written communications skills, and ability to work collaboratively in a team environment. - Demonstrated ability to clearly document design work and present and explain design choices. - Ability to work as part of a cross-functional and cross-site team, and design circuits with consideration for overall System Requirements Desired Skills: - Programming experience in C, C++, LabWindows CVI |E-mail this position Submit Resume or C.V.2012-04-12 01:38:38United StatesSt. Jude MedicalCalifornia12374CASylmar, CA27827376http://jobs.sjm.com/xml/27827376/jobUSASunnyvaleEngineering Group Leader Job Requisition #: 12375 Date Posted: 04/11/2012 Category: Tachy Product Development Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview We are seeking a hands-on highly technical Engineering Group Leader to directly work on and lead a small team of engineers on RF characterization from IC to system level on implantable biomedical products. These implantable pacemakers and implantable defibrillators save lives and provide therapy for serious medical conditions. Our devices are complex, low-power, embedded systems and include custom analog, digital, and mixed signal ICs, hybrids, and discrete components. The successful person in this role will have a strong RF background including hands-on RF characterization and leadership skills. The group lead will play a key role in growing our RF characterization capabilities and setting the example of comprehensive analysis of design, creation of appropriate characterization test plans with rationale for choices, critical evaluation of results, and trouble-shooting. This person will work closely with other cross-functional groups such as Design, ATE, Firmware, Clinical Systems, Manufacturing, and Program Management. Required Skills: • MSEE with at least 3 years or BSEE with at least 5 years of RF systems experience • Theoretical and practical understanding of RF at system level • Hands on RF characterization including use of RF bench equipment • Experience leading / mentoring engineers in RF characterization • Strong technical analysis and troubleshooting skills for products containing RF, analog / digital ICs, discrete components, embedded systems • Excellent interpersonal and communication skills with ability to multi-task • Track record working collaboratively across functions in successful product development • Demonstrated ability to organize, analyze, document, prepare for characterization test plans, reviews, and reports • Ability to pick things up quickly • Motivated to learn about and ability to lead biomedical product development • Recruiting and team building Desired Skills: • RF IC and RF Systems experience including ATE and bench equipment |E-mail this position Submit Resume or C.V.2012-04-12 01:38:12United StatesSt. Jude MedicalCalifornia12375CASunnyvale, CA27827357http://jobs.sjm.com/xml/27827357/jobUSASylmarManager, Senior Product Launch Job Requisition #: 12759 Date Posted: 04/09/2012 Category: Marketing Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mgr, Sr Product Launch Summary Acting independently and within broad policy, has primary management responsibility for developing comprehensive and integrated portfolio and commercial launch strategies within core CRM markets and product segments. Responsible for developing, executing and managing implementation of product commercialization launch plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Troubleshoots complex problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Qualifications Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible experience in medical device or pharmaceutical marketing capacity, with an emphasis on full-cycle product launch activity and commercial execution. Requires demonstrated, meaningful experience in successful launch planning and execution, particularly with product platforms. Requires highly developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Must have the demonstrated ability to understand and comply with applicable regulatory and company operating procedures, processes, policies and rules. Must be able to work cooperatively and productively with others. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential. Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:54United StatesSt. Jude MedicalCalifornia12759CASylmar, CA27772905http://jobs.sjm.com/xml/27772905/jobUSASylmarCo-op - Mechanical Engineering Student - July - Dec. Job Requisition #: 12785 Date Posted: 04/09/2012 Category: CO-OP Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Hardware Development Co-op Job Description - July through mid Dec. (Mechanical Engineering) The co-op program provides practical work knowledge and experience. This co-op engineering position will provide general support to product development in the design, development, testing and manufacturing phase. Co-ops will interface with Research and Development, Product Engineers, Quality Assurance, Regulatory Affairs and Program Managers. Learning experience includes: 1. Applying fundamental engineering principles to real world designs 2. Responsible for designing, fabricating and the assembling all forms of medical devices from initial concept to completion or modification and customization utilizing CAD software such as Pro/Engineer. 3. Designs and executes mechanical & electrical tests of ICDs and Pacers. Data collection and analysis, including writing engineering test procedures and reports. 4. Assist in managing engineering related issues and technical support at a production level. 5. Manage projects and communicate project status including formal presentation to the engineering and management community 6. Working with cross-functional team members to achieve organizational goals 7. Maintain accurate record-keeping of design and fabrication of devices, and prepare documentation such as operating instructions and project records and drawing revision control in a form of engineering change orders (ECO) utilizing product life management software such as Teamcenter. Skills and traits we typically look for, but are not limited to, include: 1) At least a junior level student in Mechanical Engineering or Biomedical Engineering. 2) Very familiar with computer aided design software such as Pro/Engineer or Solidworks. 3) Familiar with product life cycle programs (i.e. Teamcenter) a plus 4) Needs to know the basics of Word, Excel, and PowerPoint 5) Knowledge of drafting techniques and tool design 6) Excellent communication and teamwork skills for working will all levels of employment and outside vendors 7) Ambitious and willing to learn new things; Not afraid of new challenges 8) Ability to multi-task and switch to higher priority tasks with little notice 9) Knowledge of how to apply basic engineering principles to product and/or component specifications. Details: Bachelor's Students - 18/hr Master's Students - 22/hr PhD Students - 25/hr We provide full housing and travel reimbursement. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:43United StatesSt. Jude MedicalCalifornia12785CASylmar, CA27772893http://jobs.sjm.com/xml/27772893/jobUSAIrvineSenior Electrical Engineer Job Requisition #: AF13804 Date Posted: 04/05/2012 Category: Electrical Engineering Advanced Process Development Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview The Advanced Process Development-Systems (APDS) group in AFD-Irvine involves with new product development, product engineering support and develops processes and test systems for instrumentation manufacturing. We are seeking a talented, hands-on Senior Electrical Engineer to provide technical leadership on key projects, provide solutions that meet market and customer needs along with regulatory requirements. Plan, and organize engineering projects to meet company objectives for design, new product development and improvement of existing product lines – from project approval through volume production. Essential Functions: • Serve as technical leader for new product development and product improvement projects. • Provide in-depth analysis and innovative technical solutions. • Maintain and develop expertise on current technology, and apply technology to new product development. • Collaborate with PD (product development) Engineering, Manufacturing and other departments to provide design, development testing and deployment of projects. • Plan and organize projects to ensure timely and effective delivery into production and overall completion. • Manage multiple, parallel projects using formal project planning techniques. • Coordinate and lead project meetings with department representatives to ensure each project is meeting timeline. • Confer with project team members to address work procedure or project status questions, and resolve technical issues/complaints. Required Qualifications • BS in Electrical or Bioengineering and minimum 6 years relevant experience or MS in Electrical or Bioengineering and minimum 3 years relevant experience. • 5 or more years of direct experience in medical device industry. • Experienced in system design, embedded system design, analog and digital circuit design, embedded software. Knowledge of real time operating system. • Demonstrated strong technical and analytical/problem solving skills. • Write test protocols, reports and specifications. Perform bench and design V&V testing. • Experience with engineering change orders, documentation needs, protocol and report writing. Familiarity with d/pFMEA, DOE and QSR design control. • Strong verbal and written communication skills; ability to effectively communicate ideas to facilitate change at all levels of the organization. • Experienced with EE CAD tools. Preferred Qualifications • Adhere to medical device design control processes. Generate and maintain DHF (Design History File) during product development as required by project. • Experience with managing engineering projects and/or formal project management training • System architecture design experience. • Familiar with IEC standard; familiar with AAMI standards; familiar with system electrical safety requirements and EMI/EMC requirements. • Development of IQ/OQ/PQ protocols and reports for manufacturing equipment. • Experience with a variety of manufacturing processes • Experience using Lean Sigma or other Design for Manufacturability toolset required. • Review components for reliability, performance, and standardization. • Supplier technical capability reviews in partnership with supplier quality review. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction and quality improvements. • Ongoing support for component obsolescence. • Review engineering change orders. • Experience with LabView tools. |E-mail this position Submit Resume or C.V.2012-04-05 19:59:04United StatesSt. Jude MedicalCaliforniaAF13804CAIrvine, CA27668571http://jobs.sjm.com/xml/27668571/jobUSAIrvineSenior Product Dvlpmnt Engineer Job Requisition #: AF13825 Date Posted: 04/05/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Develops new test methods and procedures for the characterization of early phase catheter design concepts, as well as device verification testing. • Leads in the development and validation of standardized variable data collection test methods in both discovery and design control environments • Collects, reduces, analyzes and presents empirically derived data using DOE, ANOVA and other statistical tools. • Assists the development of design performance simulation, both closed form & computer aided numerical modeling techniques. • Establishes the definition of material performance and defines the load case required, to understand and develop a match to clinical scenarios. Required Qualifications: • BS in Mechanical, Materials or Biomedical Engineering • 6+ years of product development (R&D) experience • Direct catheter experience. • Familiarity with CAD and FEA software (e.g. ProE, Abacus, ANSYS etc.). • Process development experience – process identification and process characterization. • Demonstrable experience using MiniTab statistical analysis software. • Demonstrated ability to lead technical projects meeting established deliverables. • Direct experience leading and/or performing failure analysis. • Effective communication skills and experience working with cross functional teams. • Excellent documentation writing skills; clear and concise using objective evidence and language. • Superior organizational skills including project management aptitude. • Energized attitude |E-mail this position Submit Resume or C.V.2012-04-05 19:58:22United StatesSt. Jude MedicalCaliforniaAF13825CAIrvine, CA27668542http://jobs.sjm.com/xml/27668542/jobUSASylmarSoftware Engineer I-Firmware Development Job Requisition #: 12770 Date Posted: 04/04/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview St. Jude Medical is seeking talented embedded software developers to join our Firmware Development organization. As a software engineer on our team, you'll work in a dynamic, collaborative environment to develop high quality embedded software for our implantable medical devices that operates within very tight constraints for memory footprint, power consumption, and real-time performance for our implantable medical devices, such as cardiac pacemakers and implantable cardioverter defibrillators. Responsibilities: • Design, develop, test, debug, and maintain firmware for implantable medical devices • Other duties as assigned Qualifications: • Excellent written and oral communication skills • Strong teamwork and leadership skills • Thorough understanding of the software development lifecycle • Knowledge of computer architecture • Ability to write clear, concise code that can be maintained by others • Strong C programming skills in RTOS environments • Experience with assembly programming • Experience using version control systems • Experience with logic analyzers and other lab bench test equipment. Relevant Coursework: • Software engineering • Software algorithms • Data structures • Operating systems • Computer architecture Education: • B.S. degree in computer science, computer engineering, or related fields. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:40United StatesSt. Jude MedicalCalifornia12770CASylmar, CA27644374http://jobs.sjm.com/xml/27644374/jobUSASunnyvaleEngineer I, Software Job Requisition #: 12774 Date Posted: 04/04/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs specialized level software project activities in such areas as Development Engineering, IT Engineering, System Engineering, Test Engineering, and/or related areas. Assignments may include, but are not limited to, analyzing requirements and providing strategic feedback, planning and scheduling data, updating and maintaining different software specifications based on analysis of specifications, needs and improvements, as well as troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code based on strategic analysis. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. • Exposure to writing requirements • Exposure to embedded software • Knowledge of basic electronics, hardware design, and cardiovascular physiology • Knowledge of pacemaker and/or ICD algorithms a plus • Experience with DOORS and ClearQuest a plus • Team leadership skills including, but not limited to, resource planning and employee mentorship a plus • Ability to comfortably work in an FDA-regulated environment as part of a team with clear, well-defined processes • Someone who is high-energy, enthusiastic, and looking to make a significant contribution to the organization • Someone who is extremely meticulous (detail-oriented) Requirements/Education: Bachelor of Science Degree in Computer Science Engineering or a related engineering field. A minimum of six months of relevant software engineering work experience on multiple platforms with varied programming methods is required. Requires demonstrated written and verbal communication, interpersonal, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Evaluation, originality, and/or ingenuity required. Desired Requirements: Relevant coursework and/or a demonstrated understanding of product development/clinical engineering concepts, theory, and applications are desired. Relevant coursework and/or a demonstrated understanding of cardiac electro-physiology. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing, as well as Regulatory Affairs is also desired. Previous experience in the implantable medical device industry is preferred. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:40United StatesSt. Jude MedicalCalifornia12774CASunnyvale, CA27644376http://jobs.sjm.com/xml/27644376/jobUSASunnyvaleSenior Software Verification Engineer (C++, C#) Job Requisition #: 12829 Date Posted: 04/04/2012 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Please only apply if you have 5+ years software verification with C++ and C#. Stable work history is a must too. Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as SW Development and/or automated software Testing. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software test specifications or test libraries as well as the troubleshooting, debugging, and maintenance of software test code or test library code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs technical studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. A demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks is also required. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Required: Proficiency and/or work experience designing and implementing automated software testing is required. Proficiency and/or work experience in software utilizing a variety of programming languages such as C++, and/or C# are required. Strong written/verbal communication, analytical thinking, and problem solving skills are desired. Proficiency and/or work experience with object-oriented methodology including analysis, design, development, and structured software development is desired. Desired Requirements: An advanced credential in a relevant discipline/concentration. Specialized experience and/or relevant coursework related to the software applications, programs, and processes. Academic or in-house courses in project management, leadership, training, and various technical applications as noted above. |E-mail this position Submit Resume or C.V.2012-04-04 20:00:13United StatesSt. Jude MedicalCalifornia12829CASunnyvale, CA27644368http://jobs.sjm.com/xml/27644368/jobUSASylmarEngineer, Senior Software Job Requisition #: 12712 Date Posted: 04/04/2012 Category: Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working without appreciable supervision, performs moderate risk/highly complex software project activities in such areas as SW Development and/or automated software Testing. Assignments may include, but are not limited to, the designing, developing, updating, and maintaining of different software test specifications or test libraries as well as the troubleshooting, debugging, and maintenance of software test code or test library code at a multiple sub-systems or application levels. Assignments may also include capturing, gathering, analyzing, maintaining, and validating applicable product or software requirements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Requirements/Education: Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods. Broad cross-disciplinary and in-depth knowledge of the software engineering profession. A comprehensive familiarity with commodity/off-the-shelf software tools, and programs. A qualified record of implementing new processes to existing software and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, follow-up skills, and the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. A documented record of delivering software engineering information which adds value to managements decision making process is required. Required: Proficiency and/or work experience designing and implementing automated software testing is required. Proficiency and/or work experience in software utilizing a variety of programming languages such as C++, and/or C# are required. Strong written/verbal communication, analytical thinking, and problem solving skills are desired. Proficiency and/or work experience with object-oriented methodology including analysis, design, development, and structured software development is desired. |E-mail this position Submit Resume or C.V.2012-04-04 19:59:57United StatesSt. Jude MedicalCalifornia12712CASylmar, CA27644364http://jobs.sjm.com/xml/27644364/jobUSASunnyvaleServer Administrator Job Requisition #: 12735 Date Posted: 04/04/2012 Category: Information Technology Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under general supervision, oversees and coordinates overall activities relating to the operation and maintenance of computer servers and the installation and configuration of new computer equipment. . Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. The position will also include support of Client PC’s, responsible for the installation, repair and preventative maintenance of personal computers (PCs), networks and related systems. Performs all installations, configurations, upgrades and backups of software (i.e., Microsoft Office, Windows OS) and hardware applications at end user locations. Troubleshoots software and hardware failures and identifies network problems when they relate to PCs. Qualifications: Requirements/Education: Requires a Bachelors Degree in Computer Science or equivalent. Typically a minimum of four years technical experience in computer maintenance and repair including at least two years direct experience in the systems management and administration of a medium to large computer server and client environments supporting at least 200 users. Formal training in computer systems management and administration is also required. Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently. Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MSCE). Specific Job Skill: Solid experience required with Windows OS, VMware, MS Applications, Software Deployment Tools, and Desktop troubleshooting tools. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, virtualization, network, storage/SAN, system backups, security, Client desktop support, Software deployment) This would also include training in deskside automation support and/or service. Must have demonstrated personal computer application (e.g., spreadsheet and word processing), installation and repair skills. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. The ability to work independently. The demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies and rules is essential. Must be able to operate in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Must be a team player with excellent oral and written communication skills. |E-mail this position Submit Resume or C.V.2012-04-04 19:59:50United StatesSt. Jude MedicalCalifornia12735CASunnyvale, CA27644362http://jobs.sjm.com/xml/27644362/jobUSASylmarClinical Research Associate III Job Requisition #: 12769 Date Posted: 03/27/2012 Category: Clinical Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working with limited direction, is responsible for assisting in the coordination of clinical data collection, researching and analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, and ensuring that site administration paper work is both complete and current. In addition, this position ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Coordinates the initiation of the clinical site, conducting clinical site audits, identifying and obtaining missing data and data corrections, maintaining accurate, detailed and complete records of audits and assisting in the reporting of study results. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year course of study. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status to manager. Requirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of six plus years of experience as a Clinical Research Associate or equivalent experience which could include (but not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc.).Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Comprehensive personal computer skills including experience with word processing software and relevant clinical applications. The ability to concentrate on detail and work independently. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A familiarity with cardiac rhythm management technology, such as pacemakers, Heart Rhythm Society Heart Rhythm Society Certification in Electrophysiology (EP) and Implantable Cardioverter-Defibrillator (ICD)/Pacing or an equivalent certification of expertise, and with the clinical trial process is preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:30United StatesSt. Jude MedicalCalifornia12769CASylmar, CA27532238http://jobs.sjm.com/xml/27532238/jobUSASylmarClinical Research Associate II Job Requisition #: 12800 Date Posted: 03/30/2012 Category: Clinical Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, applies clinical judgment to identify/resolve data discrepancies and implements corrections as needed. Is also accountable for analyzing and adjudicating adverse events from research sites, coordinating clinical data collection, analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, assists in the proper reporting of study results. In addition, ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Requirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of two plus years of related work experience as a Clinical Research Associate or equivalent (e.g., Research Coordinator) experience which should include (but is not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc. Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A general familiarity with cardiac rhythm management technology, such as pacemakers, and with the clinical trial process is preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:15United StatesSt. Jude MedicalCalifornia12800CASylmar, CA27532227http://jobs.sjm.com/xml/27532227/jobUSASylmarEngineer, Principal Quality Assurance Job Requisition #: 12720 Date Posted: 03/30/2012 Category: Quality Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working without appreciable direction, designs and delivers design assurance engineering products, or processes. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. - Strong QA leader with demonstrated experience in addressing quality system and technical issues. - A background in electromechanical class III medical devices - Mechanical or electrical engineering degree holder - Demonstrated ability to work with people from diverse cultures and work with individuals/teams at off shore locations - Good knowledge of quality system regulations, ISO13485, and risk management ISO 14971 - Demonstrated ability to work with various levels of employees - A strong background in statistical techniques - Ability to critically analyze and improve upon existing procedures and develop new procedures as needed Requirements/Education: Bachelors Degree in Engineering (e.g., Electrical, Mechanical, Computer, etc.), or in a physical science, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience in a high technology manufacturing environment. Extensive knowledge and expertise at the forefront of the design assurance profession; applies, develops and promotes advanced concepts and practices; recognized authority in field. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems. |E-mail this position Submit Resume or C.V.2012-03-31 03:42:41United StatesSt. Jude MedicalCalifornia12720CASylmar, CA27532214http://jobs.sjm.com/xml/27532214/jobUSASunnyvaleEngineer I, Design Assurance Job Requisition #: 12632 Date Posted: 03/27/2012 Category: Quality Assurance Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Summary Working under close supervision on defined work assignments and/or usually following established procedures, supports the qualification testing of potential new products, accessories and components. Performs failure investigations on electrical circuits and subassemblies. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelor’s Degree in Engineering (e.g., Electrical, Mechanical, etc.), or in a physical science, a related field, or equivalent including relevant coursework and/or work experience in the design assurance profession. Requires demonstrated written and verbal communication, interpersonal, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must have the demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills and be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities. Desired Requirements: Prefer a degree in Electrical or Biomedical Engineering, experience in troubleshooting/failure analysis, specialized training, relevant coursework and/or a demonstrated understanding of design assurance engineering concepts, theory, and applications are desired. Experience in the implantable medical device industry. |E-mail this position Submit Resume or C.V.2012-03-27 20:24:08United StatesSt. Jude MedicalCalifornia12632CASunnyvale, CA27424323http://jobs.sjm.com/xml/27424323/jobUSASylmarTechnical Service Engineering Specialist Job Requisition #: 12789 Date Posted: 03/27/2012 Category: Technical Services Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. |E-mail this position Submit Resume or C.V.2012-03-27 20:23:38United StatesSt. Jude MedicalCalifornia12789CASylmar, CA27424313http://jobs.sjm.com/xml/27424313/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12713 Date Posted: 03/27/2012 Category: Technical Services Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. |E-mail this position Submit Resume or C.V.2012-03-27 20:23:10United StatesSt. Jude MedicalCalifornia12713CASunnyvale, CA27424287http://jobs.sjm.com/xml/27424287/jobUSASylmarServer Administrator, Senior Job Requisition #: 12787 Date Posted: 03/26/2012 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Server Administrator, Sr Summary Working without appreciable direction, oversees, operates and coordinates large multi-tier systems, typically operational 24x7 basis with global users, and typically comprised of multiple technologies. Integrates multiple Information Technology (IT) technologies for delivery of system services. Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. Work requires the application of technical as well as business principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Implements St. Jude Medical Cardiac Rhythm Management Division (SJM/CRMD) and IT specific policies, practices and procedures to accomplish assignments and resolves a broad range of issues and problems. Performs special assignments and projects as directed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Assures that quality of services meets requirements. Remains current on developments in field(s) of expertise. Qualifications Requirements/Education: Requires a Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of technical experience in server, network or system operations including direct experience in a medium sized server environment or larger. Must possess demonstrated knowledge and application of advanced concepts and practices in two or more server operating systems, server hardware, file system concepts and management. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, network, storage/SAN, system backups, security, telephony, Internet-based infrastructure, public facing systems). Demonstrated knowledge of and experience with integration of storage, data communications/ networking, and security implementation. Good oral and written interpersonal, communication skills to deliver customer-focused service. Excellent analytical, presentation, and organizational skills and the ability to meet multiple deadlines and work independently. Must be able to manage an assignment from start to completion; must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Ability to use discretion and handle sensitive/confidential information. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. Must also have demonstrated effectiveness in the expeditious execution of IT transactions and the ability to work with clients as a strategic business partner. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MCSE) and/or Cisco Networking certifications. Ability to program in an administrative language (e.g., Perl, shell scripting). |E-mail this position Submit Resume or C.V.2012-03-26 20:58:01United StatesSt. Jude MedicalCalifornia12787CASylmar, CA27398974http://jobs.sjm.com/xml/27398974/jobUSAIrvinePrincipal Product Development Engineer Job Requisition #: AF13821 Date Posted: 03/26/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, leading hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Leads the design and process development of new products • Represents Product Development on cross functional product development teams • Applies engineering/ design/ process knowledge to the development of new products • Manages engineering and technician support assigned to the project • Develops schedules and timelines for project work and tracks to and updates • Authors designs control documentation including specifications, requirements, reports, and protocols • Provides engineering, design and technical support of products introduced currently in release. Required Qualifications: • BS in Mechanical or Biomedical Engineering • 10 + years experience in catheter based product design/ R&D in Medical Device industry • 3+ years project leadership or management experience • Demonstrated knowledge of successful process development- process identification and process characterization • Track record of successful product transfer from Product Development to Manufacturing • Demonstrated ability to work with manufacturing to improve products and processes to increase yield(s) • Experience with medical design from initial concept generation to manufacturing • Strong analytical reasoning • Experience working within medical device regulatory systems (FDA Design Controls, ISO9001, GMP) • Polished communicator • Excellent documentation writing skills; clear and concise using objective evidence and language • Excellent reputation for building relationships • Organized, on-time, and detailed skills • Energized attitude Preferred Qualifications: • MathCAD experience • Knowledge of electrophysiology • Working knowledge of statistics • Experience w/Cardiac anatomy • Tissue ablation • Catheter design To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-26 20:58:00United StatesSt. Jude MedicalCaliforniaAF13821CAIrvine, CA27398973http://jobs.sjm.com/xml/27398973/jobUSASylmarEngineer II, Clinical-Systems Job Requisition #: 12553 Date Posted: 03/20/2012 Category: Systems Engineering Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Engineer II, Clinical-Systems Summary Working under general supervision, supports product development efforts by performing clinical-systems engineering tasks such as investigating, defining, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Responsible for gaining a firm understanding of clinical applications, customer needs to be addressed, behaviors, and architected solution of the assigned portion of the system. Performs additional analysis and/or interviews to determine requirements and constraints on the assigned portion of the system and to resolve cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Demonstrates aspects of technical or organizational leadership within the current projects. Has ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating clinical-systems engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelors Degree in Biomedical Engineering, a related field, or equivalent including relevant coursework and/or work experience in product development (especially definition and validation), cardiology and electrocardiogram interpretation. Typically a minimum of two plus years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is also required. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Documented record of delivering clinical-systems engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Desired Requirements: An advanced credential in a relevant discipline/concentration; a Biomedical Engineering degree is preferred. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Six-Sigma, and various technical applications as noted above. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2012-03-20 20:33:08United StatesSt. Jude MedicalCalifornia12553CASylmar, CA27272207http://jobs.sjm.com/xml/27272207/jobUSASylmarEngineer I, Design Assurance (software) Job Requisition #: 12700 Date Posted: 03/16/2012 Category: Quality Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under close supervision on defined work assignments and/or usually following established procedures, supports the qualification testing of potential new products, accessories and components. Possess a solid understanding of software development, verification and validation activities, processes, approaches, and methodologies. •Work with Software Engineers on the software development process, including document review, technical review meetings, change control meetings and auditing. •Monitor software configuration management, defect tracking and requirements using software tools such as ClearCase, ClearQuest and DOORs. •Implement process improvements that add value to software development projects, contribute to finding bugs earlier, and prevent failures from reaching the field. •Conduct review meetings for issues found during audits and ensure that all issues are resolved before regulatory submission. •Develop, follow and maintain internal SOPs, department work instructions, project audit plans and audit summary reports. •Schedule and perform software validations as needed for quality system software used throughout the company. •Support other departments in the validation of software for quality systems, including in-house and commercially developed software. •Must possess excellent oral and written communication skills with the ability to effectively convey schedules, issues, and results in documents, emails, and meetings. •Must be able to complete projects on schedule with a high quality results. •Must be a detail oriented person who can diplomatically catch mistakes and get corrections made. •Must have high energy and enthusiasm with a history of successful team participation. looking for a mature and responsible new grad (or soon-to-be grad) with a degree in Software Engineering, Computer Engineering or Computer Science and who has elective coursework in some of the following areas: • UNIX • Computer Security • Software Testing • Software Process • Software Quality • Web Programming and Data Management |E-mail this position Submit Resume or C.V.2012-03-16 19:25:34United StatesSt. Jude MedicalCalifornia12700CASylmar, CA27208003http://jobs.sjm.com/xml/27208003/jobUSASunnyvaleTechnical Service Engineering Specialist Job Requisition #: 12621 Date Posted: 03/15/2012 Category: Quality Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Functioning under general supervision in accordance with established policies/procedures, provides independent clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. This level of the Technical Service Engineer (TSE) provides the clinical and technical interface between the medical community and the various Cardiac Rhythm Management departments through consultation. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Requirements/Education: Requires a Bachelors Degree in electronic engineering, biomedical engineering, a related field, or equivalent. Typically a minimum of two plus years of work experience providing medical device industry technical support, including relevant experience in the cardiac pacing industry. Requires the demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. Must be able to meet deadlines on multiple projects/assignments. Must also be able to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical Engineers is required. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing, database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: Biomedical Engineering background. Knowledge of cardiac anatomy/physiology and cardiac pacing/defibrillation systems from a clinical and technological perspective is desired. A demonstrated understanding of electrocardiograms is also preferred. Candidate that can work in a fast-paced environment, with attention to detail, meet deadlines, and has excellent organizational skills. Knowledge in FDA CDRH regulations a plus. |E-mail this position Submit Resume or C.V.2012-03-15 21:38:22United StatesSt. Jude MedicalCalifornia12621CASunnyvale, CA27178514http://jobs.sjm.com/xml/27178514/jobUSAIrvineSenior Design Quality Engineer Job Requisition #: AF13715 Date Posted: 03/13/2012 Category: Engineering Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Design Quality Assurance Engineer to join our organization. This Senior Engineer partners with employees on cross functional teams focused on new product development. This DQE leads and ensures new product designs are in compliance in the following critical areas- marketing/user requirements, technical/engineering specifications, technical drawings, design verification and design validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, and manufacturing procedures. Impact this role will have within the AF division: • Provide guidance to support completion of new product development quality deliverables: risk analyses and reports including FMEAs and Fault Tree Analyses; quality, shelf life, packaging, biocompatibility, and sterility assessments and plans; others. • Review and provide guidance on creation of new product development process deliverables, ensuring deliverables meet internal requirements: marketing/user requirements, technical/engineering specifications, technical drawings, design verification and validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, manufacturing procedures, etc.. Work with process owners to develop procedures and work instructions for design control and new product development. • Ensure new product design compliance to internal Standard Operating Procedures (SOPs) and International Standards Organization 13485 and 21Code of Federal Regulations Part 820 Quality System Regulations. Ensure internal SOP compliance to external regulations. • Support and lead failure investigations including root cause analysis, correction, corrective/preventive actions, Design History File updates. Subject Matter Expert for failure investigation techniques and documentation. • Communicate any quality-related issues to Quality Management, propose and lead implementation of appropriate corrective actions. Prepare corrective action implementation project plan and schedule. • Subject Matter Expert for evaluation of effectiveness and safety of new product designs using understanding of the physiology and electrical systems of the human heart (including phenomena associated with atrial fibrillation), atrial fibrillation-related Electrophysiology (EP) lab procedures and equipment use cases, and knowledge of the design, function, and typical failure modes of devices manufactured by SJM-AFD. Required Qualifications: • B.S. Engineering degree. • Extensive product and process validation experience. • Strong written and oral communication skills. • Successful track record of being organized, ability to prioritize, and working both independently and in teams. • Experience with new product development process through project completion under 21CFR Part 820 or Medical Device Directive regulations. • Understand and able to provide guidance regarding statistical decision-making (ANOVA, hypothesis testing, goodness-of-fit, etc.), data analysis (data types, accuracy vs. precision, mean/range/standard deviation), statistically sound sampling plans and acceptance criteria, measurement system analysis (Gauge R&R, capability), risk/hazard analysis techniques (FMEA/FMECA, FTA). • 7+ years of QA experience within the medical device industry. • Experience with MS Word, MS Excel, MS Visio, Minitab. • Great reputation for leading and driving change on multiple projects. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. • Ability to influence others without authority. Preferred Qualifications: • Preferred degrees are related to medical devices, such as Biomedical or Electrical Engineering degree. • CQE, CQA certification. To learn more, visit our web site at www.sjm.com St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-13 23:44:27United StatesSt. Jude MedicalCaliforniaAF13715CAIrvine, CA27117043http://jobs.sjm.com/xml/27117043/jobUSASunnyvaleClinical Product Surveillance (CPS) Analyst Job Requisition #: 12524 Date Posted: 02/22/2012 Category: Clinical Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under the general direction of the department manager while demonstrating a high degree of discretion and independent judgment, is accountable for the professional medical analysis and validation of product surveillance documents, medical device reports (MDRs), and customer letters. Analyzes customer inquiries to ensure company responses are medically appropriate and include relevant, accurate, and thorough technical, clinical, and educational information while communicating directly with the customer. Makes recommendations to management based on these analyses. Reviews and validates product surveillance documents and medical device reports for patient safety and product efficacy. Stays abreast of and communicates developments to ensure that product surveillance files comply with U.S. Food and Drug Administration (FDA) regulations as well as company policy. Requirements/Education: Bachelors of Science Degree in Nursing (BSN) and a current nursing license or BME degree. A minimum of four plus years of relevant experience in clinical risk analysis/or technical support in the cardiac pacing industry, or equivalent. Candidate must demonstrate strong written and oral communication skills. Demonstrated ability to understand, interpret, and comply with US Food and Drug Administration (FDA) regulations and Company operating procedures. Must be able to demonstrate the ability to read and interpret medical reports as well as product documentation. Candidate must possess demonstrated organizational skills, professional and business judgment, sound decision-making and problem-solving abilities, discretion, and excellent organizational skills for managing multiple ongoing tasks. Candidate must be able to meet deadlines on multiple projects. Must be detail- and team-oriented and be able to function independently in a busy department while working with cross-functional teams and providing support to other team members. Must possess demonstrated personal computer literacy and proficiency with standard software applications, including Excel, Word or equivalent applications are required. Must be able to demonstrate the ability to read and interpret medical reports as well as product documentation. Desired Requirements: An advanced degree in a relevant discipline. Knowledge of cardiac anatomy/physiology and/or cardiac pacing/defibrillation systems from a clinical perspective is desired. RN with background in Cardiac Electrophysiology is preferred. |E-mail this position Submit Resume or C.V.2012-02-22 22:00:35United StatesSt. Jude MedicalCalifornia12524CASunnyvale, CA26691993http://jobs.sjm.com/xml/26691993/jobUSALos AngelesCo-op Job Requisition #: 12289 Date Posted: 02/16/2012 Category: CO-OP Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Co-op Summary The Co-op (i.e., Co-operative Education) program reflects a formal and structured relationship between CRMD and selected colleges and/or universities. The programs role is to provide full- or part-time practical work experience on a short-term temporary basis relevant to students academic programs while meeting the needs of the division for relevant technical and/or administrative support. Using established concepts, knowledge and procedures, performs assignments of various scope and complexity, developing/implementing solutions for routine to complex problems. Qualifications Requirements/Education: Student enrollment at a recognized college or university or having applied for graduate studies following completion of contiguous undergraduate studies in a discipline relevant to the interests and needs of the Division. Such enrollment will include the pursuit of college or graduate academic credit through work experience at the Division under a formal agreement between the Company and the students university. Demonstrated interest and familiarity with the Medical Device industry as applicable to area of study at college or university. Required to work cooperatively and productively with others. Demonstrated organizational skills and attentiveness to detail is required. Engineering students should have basic engineering design classes and have ability to work in areas of college major on engineering projects. The demonstrated ability to read, write and communicate in English is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar, and punctuation. The ability to understand and comply with applicable U. S. Food and Drug Administration (FDA) regulations and Company Operating Procedures, processes, policies and rules is required. Demonstrated proficiency in operating a personal computer. Must be proficient in using frequently used personal computer programs (e.g., Excel, Word, or equivalent) and/or be aware of basic engineering applications for the area of major engineering studies. Must be able to maintain regular and predictable attendance; the ability to work overtime is required. Desired Requirements: Posses fundamental knowledge, skills, and abilities consistent with completion of the junior year of academic study or higher. Student must be able to work up to 6 months at our on-site facilities. Electrical Engineering Students - July - December Please only apply if you can work the 6 months - this is not an internship. |E-mail this position Submit Resume or C.V.2012-02-16 19:29:34United StatesSt. Jude MedicalCalifornia12289CALos Angeles, CA26571300http://jobs.sjm.com/xml/26571300/jobUSALos AngelesServer Administrator, Senior Job Requisition #: 12332 Date Posted: 02/01/2012 Category: Information Services Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Server Administrator, Sr Summary Working without appreciable direction, oversees, operates and coordinates large multi-tier systems, typically operational 24x7 basis with global users, and typically comprised of multiple technologies. Integrates multiple Information Technology (IT) technologies for delivery of system services. Executes activities relating to the operation and maintenance of computer systems including monitoring, backups, installation, configuration and operation of new and existing IT equipment. Work requires the application of technical as well as business principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Implements St. Jude Medical Cardiac Rhythm Management Division (SJM/CRMD) and IT specific policies, practices and procedures to accomplish assignments and resolves a broad range of issues and problems. Performs special assignments and projects as directed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Assures that quality of services meets requirements. Remains current on developments in field(s) of expertise. Qualifications Requirements/Education: Requires a Bachelors Degree in Computer Science, a related field, or equivalent. Typically a minimum of six plus years of technical experience in server, network or system operations including direct experience in a medium sized server environment or larger. Must possess demonstrated knowledge and application of advanced concepts and practices in two or more server operating systems, server hardware, file system concepts and management. Broad cross-disciplinary perspective with demonstrated competency in two or more of key IT technologies (e.g., server operating systems, network, storage/SAN, system backups, security, telephony, Internet-based infrastructure, public facing systems). Demonstrated knowledge of and experience with integration of storage, data communications/ networking, and security implementation. Good oral and written interpersonal, communication skills to deliver customer-focused service. Excellent analytical, presentation, and organizational skills and the ability to meet multiple deadlines and work independently. Must be able to manage an assignment from start to completion; must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines. Ability to use discretion and handle sensitive/confidential information. Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes, policies, and tasks. Must possess advanced computer skills including a working familiarity with system management tools and utilities, spreadsheets and document applications, communication tools, and other directly relevant applications. Must also have demonstrated effectiveness in the expeditious execution of IT transactions and the ability to work with clients as a strategic business partner. Desired Requirements: A relevant advanced degree and/or appropriate professional certification, i.e., Microsoft Certified Systems Engineer (MCSE) and/or Cisco Networking certifications. Ability to program in an administrative language (e.g., Perl, shell scripting). Specific Job Skills Solid experience required with Microsoft Active Directory, Exchange Server 2010 and 2003, Microsoft clustering, Microsoft Certificate Authority, Internet security, transport protocols, server and infrastructure operations. Knowledge of interoperability in heterogeneous environment and system process automation is critical. Demonstrated experience with implementation of multi-tier applications required in medium to large-scale environment (250-1000 servers). Candidates with knowledge of multiple hardware platforms (HP and IBM) are preferred. Experience desired with high availability technologies, storage (EMC/NetApp/ NAS/SAN CIFS), support of database services, Symantec Netbackup, and Active Directory and authentication for public facing applications in a corporate environment. Candidates who have experience with multiple OS or technical skill sets are preferred. Must be a team player with excellent oral and written communication skills. |E-mail this position Submit Resume or C.V.2012-02-02 18:22:16United StatesSt. Jude MedicalCalifornia12332CALos Angeles, CA26274276http://jobs.sjm.com/xml/26274276/jobUSASylmarTechnician, Metrology Job Requisition #: 12272 Date Posted: 01/25/2012 Category: Metrology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles: Job Overview Working under general supervision, performs operational checks, preventative maintenance checks and accuracy verifications of measurement and test equipment used in production, and research and development (R&D). Takes initiative to ensure work is done accurately and completely. Performs assignments and solves problems that may have a variety of solutions. Adapts work methods to different situations. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel. Requirements/Education: High School diploma or equivalent, and Precision Measurement Electronics Lab (PMEL) certification in the U.S. military or equivalent electronics training. Typically a minimum of four or more years of progressively more responsible related work experience in the calibration of test equipment. Demonstrated knowledge and understanding of all aspects of the job, including the ability to set up and operate standard Metrology instruments, including oscilloscopes, counters, function generators, power supplies, and related equipment. Established eye-hand coordination, the capability to work with small precision devices and frequently used hand tools, a comprehensive knowledge of the calibration and test equipment required, and the ability to work independently under minimal supervision. Incumbents are required to work cooperatively and productively with others. Incumbents must also be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment. Demonstrated ability to read, write and converse in technical terminology, and perform a range of mathematical calculations and measurements. Considerable interpersonal, communication, organizational skills are required. The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills. The ability to successfully pass a reading comprehension pre-employment examination is mandatory. The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. The demonstrated ability to lift equipment weighing up to approximately seventy pounds in order to place them in storage racks or test stations. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: An Associate’s degree in Metrology, Electronic Engineering Technology, equivalent trade school/military training, or comparable related experience. Demonstrated technical ingenuity and creativity to support/assist with calibration work. |E-mail this position Submit Resume or C.V.2012-01-25 20:51:23United StatesSt. Jude MedicalCalifornia12272CASylmar, CA26111014http://jobs.sjm.com/xml/26111014/jobUSALos AngelesEngineer II, Hardware Design Job Requisition #: 12300 Date Posted: 01/24/2012 Category: Leads Development Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Engineer II, Hardware Design Summary Working under general supervision, designs hardware to support features that are included as part of new product definitions. Designs verification testing (DVT) protocols. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Qualifications Requirements/Education: Bachelor of Science degree in mechanical engineering, a related field, or equivalent. Typically a minimum of three plus years of relevant hardware design, development, or testing experience including a general familiarity of manufacturing equipment/processes that is compatible with highly reliable electronic medical or similar devices. Ability to implement new design features as part of existing systems. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Ability to deliver research information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Six-Sigma knowledge and experience. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. Engineer II, Hardware Design Summary Working under general supervision, designs hardware to support features that are included as part of new product definitions. Designs verification testing (DVT) protocols. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Qualifications Requirements/Education: Bachelor of Science degree in electrical/mechanical/biomedical engineering, a related field, or equivalent. Typically a minimum of three plus years of relevant hardware design, development, or testing experience including a general familiarity of manufacturing equipment/processes that is compatible with highly reliable electronic medical or similar devices. Ability to implement new design features as part of existing systems. Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Ability to deliver research information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Six-Sigma knowledge and experience. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2012-01-24 20:55:06United StatesSt. Jude MedicalCalifornia12300CALos Angeles, CA26086255http://jobs.sjm.com/xml/26086255/jobUSASylmarEngineer I, Green Belt Continuous Improvement Job Requisition #: 12276 Date Posted: 01/24/2012 Category: Continuous Improvement Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Our Continuous Improvement group has a unique opportunity for a talented and skilled CI Green Belt who will be responsible for our Orange Belt and Green Belt certification programs. This is an excellent opportunity to join a well established program where CI is supported within the culture of the company. This opportunity will allow you to work for a medical device company where your contributions will significantly impact the quality of life of others. Position Duties: Working under Close supervision, have responsibility for our internal Orange Belt and Green Belt certification programs. Within the first six months on the job, the new hire will take ownership of all facets of our Orange Belt program. This includes teaching workshops in Lean and Mistake Proofing, mentoring candidates to implement improvements and create supporting documentation, coordinating and hosting monthly certificate boards and quarterly certification ceremonies, performing needed administrative tasks such as processing award checks and marketing the program internally for greater use. Additionally, within the first 6 months on the job, the new hire will co-sponsor the Green Belt program. This will include providing lectures on all Six Sigma subjects, mentoring candidates and coordinating Gate Reviews. As the new hire adjusts to the role, long term it is expected the person will begin developing new training material for the Orange Belt and Green Belt programs to eventually take full ownership of both programs. This person will also be expected to gain a strong understanding of St. Jude Medical as a company to maximize the benefit they bring to the organization through the application of CI tools and concepts. Requirements: Bachelors Degree in Engineering, or related field. Formal Green Belt certification from ASQ or a leading provider such as Air Academy, George Group, SigmaPro. Minimum three years or equivalent of experience providing training, mentoring candidates, & leading projects. Preferred work history in technical field such as aerospace, medicine, nuclear, or electronics |E-mail this position Submit Resume or C.V.2012-01-24 20:54:03United StatesSt. Jude MedicalCalifornia12276CASylmar, CA26086134http://jobs.sjm.com/xml/26086134/jobUSALos AngelesField Clinical Engineer, AF Job Requisition #: USD 9395 Date Posted: 01/04/2012 Category: Field Engineer Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our US Sales Division: Job Overview Under the general supervision of the Field Service Manager is responsible for demonstration, set-up, testing, installation and service of Company products which include devices and equipment for diagnosis, monitoring, managing and treating arrhythmias. Essential Functions: Provide Support for sales and marketing personnel in the set up and demonstration of Company products including the development and presentation of sales proposals. Provide technical support to customers and prospective customers by responding to inquiries and providing effective and timely resources and /or personal competencies. Provide educational and training support to customers and prospective customers including on-site clinical training for physicians and other medical personnel. Respond to emergency situations involving the use of Company products. Provide on-call or on-site resources to solve equipment and /or usage issues. Provide required support to Field Service personnel in the routine service of Company products. Develop and maintain effective professional relationships with physicians and EP Lab personnel. Represent the Company as a professional and competent resource in support of client and Company objectives. Qualified candidates will have two years of related experience including familiarity with cardiac electrophysiology equipment in EP lab environment including installation and repair of related hardware/software. A good understanding of MS-DOS, MS-Windows and PCs as well as good verbal and written communication skills. A willingness to travel approximately 80% of the time. A college degree in related disciplines is preferred. Ability to travel for long periods (up to 6 hrs) either by airplane or automobile. Ability to stand for long periods in clinical cases (up to 6 hours). Move and manipulate large, heavy objects during installation/demo and service activity (up to 60lbs.) |E-mail this position Submit Resume or C.V.2012-01-04 18:48:24United StatesSt. Jude MedicalCaliforniaUSD 9395CALos Angeles, CA25690399http://jobs.sjm.com/xml/25690399/jobUSASunnyvaleQuality Technician Job Requisition #: 12039 Date Posted: 12/14/2011 Category: Technician Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Working under general supervision, provides quality inspection and support services as required by Company quality provisions. Takes initiative to ensure work is done accurately and completely. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel within the Quality organization. Requirements/Education: High School diploma or equivalent. A minimum of four or more years related experience in quality/inspection activities. Demonstrated knowledge and understanding of all aspects of the job, including common inspection methods. Demonstrated ability to use frequently used hand tools. Demonstrated verbal and written communication, interpersonal, organizational and basic math skills. Demonstrated ability to read and understand engineering drawings. Must be able to maintain regular and predictable attendance; the ability work overtime is also required. Desired Requirements: 1-2 years of experince. An Associates degree in Electrical/Mechanical Technology, equivalent trade school/military training, or comparable related experience in biomedical field. Prior experience working in an air-conditioned clean-room manufacturing environment. |E-mail this position Submit Resume or C.V.2011-12-14 23:10:48United StatesSt. Jude MedicalCalifornia12039CASunnyvale, CA25361322http://jobs.sjm.com/xml/25361322/jobUSASunnyvaleSr. Software Development Engineer Job Requisition #: AF13676 Date Posted: 12/12/2011 Category: Software Location: Sunnyvale - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Atrial Fibrillation Division. Job Overview We are seeking an experienced, high caliber Senior Software Engineer to meet our standard product development needs as well as increase our ability to deliver integrated hardware and software solutions to meet our project specific requirements. Impact this role will have within the AF division: • The Senior R&D Software Engineer designs and develops application software for RF ablation systems. • This role writes product requirement documents, designs, develops code, unit tests and helps out the verification team. Required Qualifications: • Bachelor’s degree in Computer Science, Computer or Electrical Engineering • 7 + years hands-on development experience with real-time embedded hardware, software design and development, and programming experience in C/C++, QT, Object Oriented programming with knowledge of Hardware interfaces and microprocessors • Experience with Linux, or other real time operation system, OS kernel module, device driver development • Familiarity with software configuration and software defect tracking systems • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks • Effective verbal and written communication skills to interact with associates at all levels of the organization, vendors and other SJM entities • Adaptability to frequent change in the work environment • Ability to prioritize responsibilities and ensure deadlines are met • Proficient working knowledge of MS Word, Outlook, PowerPoint, Excel and Project • Experience with 3D image processing, registration and rendering software design, Wireless protocols • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Masters degree in Computer Science, Computer or Electrical Engineering • Experience with RTOS, debugging tools and good software development processes • Working knowledge of entire software development and test cycle with at least one complete FDA regulated medical device product development cycle. Knowledge of applicable international regulations and standards (QSR, ISO 13485, ISO14971) • Formal training in Program/Project Management or Program Management Professional Certification |E-mail this position Submit Resume or C.V.2011-12-12 21:45:19United StatesSt. Jude MedicalCaliforniaAF13676CASunnyvale, CA25308317http://jobs.sjm.com/xml/25308317/jobUSASylmarProgrammer Analyst II Job Requisition #: 12016 Date Posted: 12/08/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Programmer Analyst II Summary Working under general direction, maintains business application systems. Performs all phases of systems and programming development and maintenance by preparing detailed specification from which programs will be written in support of the assigned project(s) or group(s). Performs systems analysis, programming, problem resolution and internal consulting for new and existing technical systems applications, including vendor packages. Analyzes and revises system logic, coding and documentation as necessary. Qualifications Requirements/Education: Bachelors degree in Information Systems (IS), Computer Science (CS), a related field, or equivalent. Typically a minimum of three plus years of progressively more responsible systems analysis, design, programming and testing experience. Broad knowledge of RPG/400, JAVA, C++ and /or Visual Basic; experience with software engineering concepts. Demonstrated experience working on a large projects in a team environment. An understanding of system architecture principles as well as a variety of databases, procedural languages and data communications is required. Ability to translate client requirements into a feasible design solution. Demonstrated ability to use proper coding techniques and efficiencies, testing methodologies, with an understanding of the operating system. Planning, organizational, interpersonal and communication skills. Demonstrated verbal and written analytical/problem solving, communication, interpersonal and presentation skills required sufficient to conduct discussions, interviews, negotiations, and give presentations. Must be able to handle multiple projects simultaneously. Demonstrated personal computer skills including spreadsheet, word processing and data base management. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), and various technical applications as noted above. Specific Job Skills Specific and Preferred: Experience and knowledge of manufacturing processes, SAP, SAP middleware, and labeling systems preferred. Must be a team player with excellent oral and written communication skills and able to travel up to 20%. |E-mail this position Submit Resume or C.V.2011-12-08 18:56:02United StatesSt. Jude MedicalCalifornia12016CASylmar, CA25251483http://jobs.sjm.com/xml/25251483/jobUSASunnyvaleBiostatistician Job Requisition #: 11977 Date Posted: 11/30/2011 Category: Clinical Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Accountable to provide statistical input into the design of clinical studies, investigational plans, case report forms, database setup, edit checks, and clinical reports. Also responsible for providing consulting services to departments other than Clinical Affairs. Monitors own work performance and reports status to management. Coordinates technical decisions across organizational lines. Remains abreast of and consults on biostatistical and related advancements. Assures that quality of services meets or exceeds internal customer requirements. Requirements/Education: Masters of Science degree Biostatistics with 3 years experience of PhD in Biostatistics with 1-2 years experience. Prefer exposure to medical device industry. Requirements include an expert knowledge and experience of: computer science; biostatistical theory and application; and effective methods of working with clinical teams. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering biostatistical information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized statistical software packages with an emphasis on strong skills using Statistical Analysis System (i.e., SAS) software. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. |E-mail this position Submit Resume or C.V.2011-11-30 23:14:47United StatesSt. Jude MedicalCalifornia11977CASunnyvale, CA25120522http://jobs.sjm.com/xml/25120522/jobUSASylmarInformation Security Architect, Specialist Job Requisition #: 11965 Date Posted: 11/29/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Info Security Architect, Spec Summary Working independently with rare managerial oversight and direction, is accountable for the security design of the Divisions information systems and for ensuring that the information technology (IT) systems are protected from any and all threats. Executives on a range of security-related issues including establishing information system boundaries, assessing the severity of weaknesses and deficiencies in information systems, plans of action and milestones, risk mitigation approaches, security alerts, and potential adverse effects of vulnerabilities. Identifies and routinely uses most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness. Work requires the application of business principles/methods, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year academic course of study. Exercises significant independent judgment in the planning, organizing and performing of work assignments; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise. May participate on or lead work teams; may provide work direction or guidance to a group of employees. Qualifications Requirements/Education: A Bachelors Degree in Computer Science, Engineering, or a related technical academic field. A minimum of six plus years of progressively more responsible Information Systems experience. Evaluation, originality and/or ingenuity required. Expert proficiency in all aspects of information security, (e.g. system design, vulnerability management, risk analysis, forensics). Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering IT security information that adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA), information security and privacy regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must be able to maintain regular and predictable attendance. Desired Requirements: An advanced credential in a relevant discipline/concentration. Applicable certifications (e.g. Certified Information Systems Security Professional (CISSP), Certified Ethical Hacker (CEH)) Specific Job Skills CISSP, Certified Ethical Hacker, InfoSec assessments |E-mail this position Submit Resume or C.V.2011-11-29 19:40:33United StatesSt. Jude MedicalCalifornia11965CASylmar, CA25090377http://jobs.sjm.com/xml/25090377/jobUSAIrvineManufacturing Manager II Job Requisition #: AF13629 Date Posted: 11/23/2011 Category: Manufacturing Location: Irvine - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, talented and results-oriented Manufacturing Manager II to join our Irvine, California facility. The successful candidate will manage and lead the production and distribution activities for a three shift manufacturing facility. Impact this role will have within the AF division: • Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development. • Accountable for the development of staff: critiques, instructs, mentors, evaluates and coaches to maintain current industry standards for field of responsibility and that safety requirements for laboratories and chemical handling are met within department. • Maintains a strong customer focus. • Models optimum leadership competencies to inspire an energized, empowered and accountable work force. • Develops/monitors/controls budgets for multiple assigned areas and meets area financial objectives. • Cooperatively develops annual operational build and financial plans and over achievement/continuous improvement plans. • Determines resources to meet project objectives and manage budgets. • Forecasts and reports resource consumption area activity, performance and financial trends. Monitor/reduce inventory levels. • Develops production plans and initiates activity to meet production demand requirements and business needs. • Leads capital improvement projects and prepares capital expenditure requirements. • Conducts feasibility studies and develops project schedules. • Provide vision, strategies and tactics to ensure sustainable competitive advantage of assigned areas. • Maintains regular, reliable, and predictable attendance. • Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other essential functions and responsibilities as determined by the company from time to time. Required Qualifications: • Bachelors Degree in Business, Engineering or Sciences. • 7+ years of leadership experience in a high-volume, multi-product manufacturing environment. • Ability to learn, train, and follow good manufacturing practices (FDA/GMP's) and other applicable regulatory standards (i.e., ISO9000) and ensures operational compliance. • Solid people management skills, including demonstrated ability to coach, mentor and develop employees. • Solid communication, interpersonal, and motivational skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience leading and implementing lean manufacturing/Six Sigma and change initiatives. • Medical device industry experience. • Masters Degree in Business, Engineering or Sciences. • SAP. To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2011-11-23 16:26:07United StatesSt. Jude MedicalCaliforniaAF13629CAIrvine, CA25029408http://jobs.sjm.com/xml/25029408/jobUSASunnyvaleBiostatistician Job Requisition #: 11855 Date Posted: 11/08/2011 Category: Clinical Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Accountable to provide statistical input into the design of clinical studies, investigational plans, case report forms, database setup, edit checks, and clinical reports. Also responsible for providing consulting services to departments other than Clinical Affairs. Monitors own work performance and reports status to management. Coordinates technical decisions across organizational lines. Remains abreast of and consults on biostatistical and related advancements. Assures that quality of services meets or exceeds internal customer requirements. Requirements/Education: Masters of Science degree Biostatistics with 3 years experience of PhD in Biostatistics with 1-2 years experience. Prefer exposure to medical device industry. Requirements include an expert knowledge and experience of: computer science; biostatistical theory and application; and effective methods of working with clinical teams. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering biostatistical information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized statistical software packages with an emphasis on strong skills using Statistical Analysis System (i.e., SAS) software. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. |E-mail this position Submit Resume or C.V.2011-11-08 20:41:09United StatesSt. Jude MedicalCalifornia11855CASunnyvale, CA24757508http://jobs.sjm.com/xml/24757508/jobUSALos AngelesEngineer II, Clinical-Systems Job Requisition #: 11808 Date Posted: 10/13/2011 Category: Clinical-Systems Engineering Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Sunnyvale, CA: Job Overview Engineer II, Clinical-Systems Summary Working under general supervision, supports product development efforts by performing clinical-systems engineering tasks such as investigating, defining, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Responsible for gaining a firm understanding of clinical applications, customer needs to be addressed, behaviors, and architected solution of the assigned portion of the system. Performs additional analysis and/or interviews to determine requirements and constraints on the assigned portion of the system and to resolve cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Demonstrates aspects of technical or organizational leadership within the current projects. Has ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises basic technical judgment in planning, organizing, performing, and/or coordinating clinical-systems engineering work. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes. Qualifications Requirements/Education: Bachelors Degree in Biomedical Engineering, a related field, or equivalent including relevant coursework and/or work experience in product development (especially definition and validation), cardiology and electrocardiogram interpretation. Typically a minimum of two plus years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience. The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is also required. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Documented record of delivering clinical-systems engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly. Desired Requirements: An advanced credential in a relevant discipline/concentration; a Biomedical Engineering degree is preferred. Professional certification or designation. Academic or in-house courses in project management, leadership, training, Six-Sigma, and various technical applications as noted above. Training and experience in manufacturing processes and methods. Experience in the manufacturing of medical devices. |E-mail this position Submit Resume or C.V.2011-10-14 20:11:44United StatesSt. Jude MedicalCalifornia11808CALos Angeles, CA24231647http://jobs.sjm.com/xml/24231647/jobUSALos AngelesManager, Product Marketing Job Requisition #: 11816 Date Posted: 10/13/2011 Category: Marketing Location: Los Angeles - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Mgr, Product Marketing Summary Working under limited supervision, has primary management responsibility for developing comprehensive and integrated portfolio and commercial strategies within core CRM markets and product segments. Responsible for early phase product planning activities including business justification, executing and managing implementation of commercial strategies and development and execution of product commercialization plans. Recommends, interprets and implements corporate, division or organizationally specific policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises discretion and sound judgment in planning/organizing work; monitors performance and reports status to management. Qualifications Requirements/Education: Bachelors degree in Marketing, Engineering, Business, a related field, or equivalent. Typically a minimum of six plus years of progressively more responsible experience in a Marketing capacity, with focus on strategic product planning and commercial execution. Requires developed leadership skills/experience, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team meeting multiple project schedules on time. Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication skills (i.e., English grammar and style), negotiation, interpersonal and presentation skills are essential; Must be able to demonstrate advanced personal computer skills including experience with relevant systems/applications, word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel, PowerPoint, and Access). Desired Requirements: An advanced credential in a relevant discipline/concentration such as an MBA. Professional certification or designation. Academic courses in leadership, training, Continuous Improvement (CI), cycle time improvement, or related programs preferred. |E-mail this position Submit Resume or C.V.2011-10-14 20:11:21United StatesSt. Jude MedicalCalifornia11816CALos Angeles, CA24231634http://jobs.sjm.com/xml/24231634/jobUSASylmarSystems Analyst, Senior Job Requisition #: 11536 Date Posted: 08/25/2011 Category: Information Technology Location: Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Senior Systems Analyst – Information Security Here’s an excellent and exciting opportunity to join a progressive IT group with the responsibility of information security. This is not an operations role but an opportunity that will allow you to do security design work, focusing on architect solutions from the start or design solutions for existing systems. Your primary focus as it relates to information security will be on remote care and protection of health care information. You are responsible for protecting, by design, our complex IT systems against information security vulnerabilities and threats. If you have substantial experience doing information security engineering work and have architected security systems, we want to hear from you. Within this role, if hired, your initial focus will primarily be on information security design work on remote care/health care information. You will be expected to deliver technical Information requirements and review detailed designs from all layers of IT technology such as database, operating system, networking, middleware, etc. You will work with the InfoSec compliance team to map regulatory requirements to IT architecture. Longer term, when these systems are subject to compliance audits the systems that you participated in designing will be found to be sound and compliant with our InfoSec policies and regulatory requirements in information Confidentiality, Integrity and Availability. If hired, you will interact with non-IT personnel as much as with IT personnel, such as SW development, System Engineering, Legal, Product Development, etc. Will work with a small but very dedicated team in IT Information Security that takes their stewardship of our information assets very seriously. Will often work largely independently with no micro-management. Within this role, it is expected you to be a Certified Information Systems Security Professional (CISSP); hands-on experience securing IT infrastructure and/or code; experience in designing and documenting designs of security controls for IT Systems; excellent presentation and communication skills. Must have 5+ years experience with a focus on information security. Desired skills include being a Certified Ethical Hacker (CEH); ISO 27001/27002; software development experience; Information forensics; InfoSec incident management; biotech industry experience. Experience with health care information is a big plus. |E-mail this position Submit Resume or C.V.2011-09-27 19:28:11United StatesSt. Jude MedicalCalifornia11536CASylmar, CA23871408http://jobs.sjm.com/xml/23871408/jobUSASunnyvaleDirector, ATE Job Requisition #: 11370 Date Posted: 07/25/2011 Category: ATE Location: Sunnyvale - CA - USA Sylmar - CA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview Join the Cardiac Rhythm Management Division's Automated Test Engineering group. We are one of the world's leaders in the life-saving field implantable cardiac rhythm management devices, and we are looking to get even better by bringing on the world's best engineering talent! As a manager in the test engineering group, you will plan and manage all areas within test development. Your team will be involved in product development, design for testability, test hardware and software design, hands-on debug, characterization, manufacturing release and sustaining. You will manage 5 to 20 engineers and technicians, with analog, mixed-signal and digital technical focus. You may be involved in wafer level IC test development, test development for partial system assemblies, or device level test of the final product. You will be in charge of a key engineering function in the company's largest business division. Requirements: BSEE or MSEE 10+ years experience in analog or mixed-signal test development 5+ years managing test engineers "Hands-on". Technically savvy, especially with analog and mixed-signal circuits Excellent communication skills. Masterful at avoiding miscommunication, providing clear expectations. Focused and able to meet goals |E-mail this position Submit Resume or C.V.2011-07-25 18:20:57United StatesSt. Jude MedicalCalifornia11370CASunnyvale, CA22602291http://jobs.sjm.com/xml/22602291/job