[{"country_short": "USA", "city": "Irvine", "description": "Quality Engineer\nJob Requisition #: AF13886\nDate Posted: 05/21/2012\nCategory: Engineering Quality\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have:\n\u2022 Performs process and product qualification as outlined in a validation protocol to ensure finished products meet standards.\n\u2022 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.\n\u2022 Assists in the implementation of changes required as a result of internal audit findings.\n\u2022 Assists with IQ/OQ during development stage in preparation for process implementation.\n\u2022 Participates on new product development cross-functional teams.\n\u2022 Performs material processing.\n\u2022 Performs statistical analysis reports on a monthly basis.\n\nRequired Qualifications:\n\u2022 Bachelor\u2019s degree in Electrical Engineering\n\u2022 3+ years of experience in a quality assurance role within a manufacturing environment\n\u2022 Experience with different types of testing including analytical testing, performance testing, design verification testing, material testing, and chemistry\n\u2022 Knowledge of standards\n\u2022 Experience with materials testing, analytical testing, performance testing, biocompatibility testing, design verification testing\n\u2022 Experience supporting a manufacturing environment\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings\n\u2022 Excellent reputation for building relationships\n\u2022 Organized, on-time, and detailed project management skills\n\u2022 Energized attitude\n\nPreferred Qualifications:\n\u2022 Soldering certification\n\u2022 Medical device experience\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-21 20:25:06", "url": "http://jobs.sjm.com/xml/28837110/job", "country": "United States", "company": "St. Jude Medical", "title": "Quality Engineer", "reqid": "AF13886", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28837110}, {"country_short": "USA", "city": "Irvine", "description": "Systems Engineer I\nJob Requisition #: AF13885\nDate Posted: 05/21/2012\nCategory: Systems Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\n\nImpact this role will have within the AF division:\nUses engineering knowledge to participate in the development of innovative medical devices or components/subsystems in support of company\u2019s 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:\n\n\u2022 Conceptualize new processes and testing methods using device knowledge and innovative thinking.\n\u2022 Develop manufacturing assembly procedures and fixturing using mechanical, electrical, and software engineering skills.\n\u2022 Develop test procedures and test equipment using mechanical, electrical, and software engineering skills.\n\u2022 Develop, review, and challenge product and process specifications.\n\u2022 Create product and test equipment drawings and/or models.\n\u2022 Participate in pFMEA activities.\n\u2022 Generate IQ/OQ/PQ protocols and reports for manufacturing equipment.\n\u2022 Review components for reliability, performance, and standardization.\n\u2022 Facilitating and assembling rapid turn prototype, feasibility, and test product builds.\n\u2022 Ongoing support for cycle time reduction, quality improvements, and component obsolesence.\n\u2022 Review engineering change orders.\n\u2022 Run empirical and experimental analysis.\n\u2022 Work with outside consultants, vendors, and the medical community.\n\u2022 Conduct work in accordance with design control and quality system requirements.\n\u2022 Participate in design reviews.\n\u2022 Work on process design and development for new atrial fibrillation mapping, visualization, and recording systems.\n\nRequired Qualifications:\n\u2022 Bachelor\u2019s Degree in Engineering or Scientific discipline, advanced degree preferred.\n\u2022 0-3 years experience, preferably in process development for electrical systems.\n\u2022 Experience with development of medical devices preferred.\n\u2022 CAD Experience in Solidworks and/or Altium preferred.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-21 20:25:02", "url": "http://jobs.sjm.com/xml/28837108/job", "country": "United States", "company": "St. Jude Medical", "title": "Systems Engineer I", "reqid": "AF13885", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28837108}, {"country_short": "USA", "city": "Irvine", "description": "Assembler - 3rd Shift\nJob Requisition #: AF13883\nDate Posted: 05/11/2012\nCategory: Assembly\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpacts this role will have within the AF division:\n\u2022 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).\n\u2022 Understand and accurately complete necessary paperwork.\n\u2022 Perform general housecleaning activities.\n\u2022 Other duties as assigned, including training support as defined by area Group Leader.\n\nRequired Qualifications:\n\u2022 Qualified candidates will have a High School diploma or equivalent.\n\u2022 Minimum of six months high tech assembly experience required, preferably in medical device industry.\n\u2022 Candidates with at least 4 months specific product line experience may be considered.\n\u2022 Must have demonstrated ability to read and understand written procedures and follow directions.\n\u2022 Must have a high level of attention to detail.\n\u2022 Must be able and willing to work overtime.\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-11 18:46:54", "url": "http://jobs.sjm.com/xml/28634580/job", "country": "United States", "company": "St. Jude Medical", "title": "Assembler - 3rd Shift", "reqid": "AF13883", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28634580}, {"country_short": "USA", "city": "Irvine", "description": "Assembler - 2nd Shift\nJob Requisition #: AF13884\nDate Posted: 05/11/2012\nCategory: Assembly\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpacts this role will have within the AF division:\n\u2022 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).\n\u2022 Understand and accurately complete necessary paperwork.\n\u2022 Perform general housecleaning activities.\n\u2022 Other duties as assigned, including training support as defined by area Group Leader.\n\nRequired Qualifications:\n\u2022 Qualified candidates will have a High School diploma or equivalent.\n\u2022 Minimum of six months high tech assembly experience required, preferably in medical device industry.\n\u2022 Candidates with at least 4 months specific product line experience may be considered.\n\u2022 Must have demonstrated ability to read and understand written procedures and follow directions.\n\u2022 Must have a high level of attention to detail.\n\u2022 Must be able and willing to work overtime.\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-11 18:46:54", "url": "http://jobs.sjm.com/xml/28634579/job", "country": "United States", "company": "St. Jude Medical", "title": "Assembler - 2nd Shift", "reqid": "AF13884", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28634579}, {"country_short": "USA", "city": "Irvine", "description": "Quality Control Inspector\nJob Requisition #: AF13852\nDate Posted: 05/01/2012\nCategory: Quality Control\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have within the AF division:\n\u2022 Perform visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures.\n\u2022 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.\n\u2022 Communicate with Quality/Manufacturing Engineering and Management on quality issues.\n\u2022 Practice Good Manufacturing Practices (GMPs) including documentation practices and proper gowning techniques.\n\u2022 Review device history records for sign-off of completion of operation and accuracy.\n\u2022 When applicable, initiate and complete nonconforming material reports to ensure appropriate disposition of nonconforming material.\n\u2022 Provide and complete required GMP, Issue resolution and task specific training.\n\u2022 Assist in the implementation of changes required.\n\u2022 Support quality inspection functions of other manufacturing cell product lines as needed.\n\nRequired Qualifications:\n\u2022 High School diploma\n\u2022 Prior experience with Quality Control in a manufacturing environment.\n\u2022 Execute test protocols, final inspection testing under engineer supervision.\n\u2022 Be able to communicate ideas effectively both verbally and in writing and to facilitate change.\n\u2022 Working knowledge of Good Manufacturing Practices (GMPs).\n\u2022 Excellent interpersonal and communication skills are essential for success.\n\u2022 Must be able to work well with others in a team environment and have a hands-on approach to problem solving.\n\u2022 Must possess the ability to handle multiple tasks with attention to detail.\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings\n\u2022 Excellent reputation for building relationships across various levels of an organization.\n\u2022 Organized, on-time, and detailed project management skills.\n\u2022 Energized attitude.\n\nPreferred Qualifications:\n\u2022 Experience in an Inspector role.\n\u2022 Prior experience in the medical device industry.\n\n\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-01 19:14:51", "url": "http://jobs.sjm.com/xml/28305015/job", "country": "United States", "company": "St. Jude Medical", "title": "Quality Control Inspector", "reqid": "AF13852", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28305015}, {"country_short": "USA", "city": "Irvine", "description": "Product Development Engineer II\nJob Requisition #: AF13842\nDate Posted: 04/17/2012\nCategory: Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have within the AF division:\n\u2022 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.\n\u2022 Independently focuses on design improvements having merit and meeting the robustness of design for manufacturability.\n\u2022 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.\n\u2022 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.\n\u2022 Identifies key attributes for advancing the state of the art of related products to the core business.\n\nRequired Qualifications:\n\u2022 Requires Bachelor\u2019s degree\n\u2022 3+ years as a product development engineer with experience in all aspects of development activity of disposable medical devices\n\u2022 Demonstrated success in bringing new products from concept to market\n\u2022 Knowledge of design controls as well as FDA Quality System Requirements\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings\n\u2022 Excellent reputation for building relationships across various levels of an organization\n\u2022 Organized, on-time, and detailed project management skills\n\u2022 Energized attitude\n\nPreferred Qualifications:\n\u2022 Bachelor\u2019s degree in Mechanical Engineering\n\u2022 Familiar with ISO standards, GMP and GLP procedures.\n\u2022 Have high level understanding of design analysis and root cause failure analysis procedures for disposable catheters, preferably electrophysiology catheters.\n\u2022 Experience with design and processes involved in catheter manufacturing including extrusion and injection molding.\n\nSt. Jude Medical is an equal opportunity employer.\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-17 18:48:09", "url": "http://jobs.sjm.com/xml/27948908/job", "country": "United States", "company": "St. Jude Medical", "title": "Product Development Engineer II", "reqid": "AF13842", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27948908}, {"country_short": "USA", "city": "Irvine", "description": "Senior Electrical Engineer\nJob Requisition #: AF13804\nDate Posted: 04/05/2012\nCategory: Electrical Engineering Advanced Process Development\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nThe 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 \u2013 from project approval through volume production.\n\nEssential Functions:\n\n\u2022 Serve as technical leader for new product development and product improvement projects.\n\u2022 Provide in-depth analysis and innovative technical solutions.\n\u2022 Maintain and develop expertise on current technology, and apply technology to new product development.\n\u2022 Collaborate with PD (product development) Engineering, Manufacturing and other departments to provide design, development testing and deployment of projects.\n\u2022 Plan and organize projects to ensure timely and effective delivery into production and overall completion.\n\u2022 Manage multiple, parallel projects using formal project planning techniques.\n\u2022 Coordinate and lead project meetings with department representatives to ensure each project is meeting timeline.\n\u2022 Confer with project team members to address work procedure or project status questions, and resolve technical issues/complaints.\n\nRequired Qualifications\n\n\u2022 BS in Electrical or Bioengineering and minimum 6 years relevant experience or MS in Electrical or Bioengineering and minimum 3 years relevant experience.\n\u2022 5 or more years of direct experience in medical device industry.\n\u2022 Experienced in system design, embedded system design, analog and digital circuit design, embedded software. Knowledge of real time operating system.\n\u2022 Demonstrated strong technical and analytical/problem solving skills.\n\u2022 Write test protocols, reports and specifications. Perform bench and design V&V testing.\n\u2022 Experience with engineering change orders, documentation needs, protocol and report writing. Familiarity with d/pFMEA, DOE and QSR design control.\n\u2022 Strong verbal and written communication skills; ability to effectively communicate ideas to facilitate change at all levels of the organization.\n\u2022 Experienced with EE CAD tools.\n\nPreferred Qualifications\n\n\u2022 Adhere to medical device design control processes. Generate and maintain DHF (Design History File) during product development as required by project.\n\u2022 Experience with managing engineering projects and/or formal project management training\n\u2022 System architecture design experience.\n\u2022 Familiar with IEC standard; familiar with AAMI standards; familiar with system electrical safety requirements and EMI/EMC requirements.\n\u2022 Development of IQ/OQ/PQ protocols and reports for manufacturing equipment.\n\u2022 Experience with a variety of manufacturing processes\n\u2022 Experience using Lean Sigma or other Design for Manufacturability toolset required.\n\u2022 Review components for reliability, performance, and standardization.\n\u2022 Supplier technical capability reviews in partnership with supplier quality review.\n\u2022 Facilitating and assembling rapid turn prototype, feasibility, and test product builds.\n\u2022 Ongoing support for cycle time reduction and quality improvements.\n\u2022 Ongoing support for component obsolescence.\n\u2022 Review engineering change orders.\n\u2022 Experience with LabView tools.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-05 19:59:04", "url": "http://jobs.sjm.com/xml/27668571/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Electrical  Engineer", "reqid": "AF13804", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27668571}, {"country_short": "USA", "city": "Irvine", "description": "Senior Product Dvlpmnt Engineer\nJob Requisition #: AF13825\nDate Posted: 04/05/2012\nCategory: Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have:\n\u2022 Develops new test methods and procedures for the characterization of early phase catheter design concepts, as well as device verification testing.\n\u2022 Leads in the development and validation of standardized variable data collection test methods in both discovery and design control environments\n\u2022 Collects, reduces, analyzes and presents empirically derived data using DOE, ANOVA and other statistical tools.\n\u2022 Assists the development of design performance simulation, both closed form & computer aided numerical modeling techniques.\n\u2022 Establishes the definition of material performance and defines the load case required, to understand and develop a match to clinical scenarios.\n\nRequired Qualifications:\n\u2022 BS in Mechanical, Materials or Biomedical Engineering\n\u2022 6+ years of product development (R&D) experience\n\u2022 Direct catheter experience.\n\u2022 Familiarity with CAD and FEA software (e.g. ProE, Abacus, ANSYS etc.).\n\u2022 Process development experience \u2013 process identification and process characterization.\n\u2022 Demonstrable experience using MiniTab statistical analysis software.\n\u2022 Demonstrated ability to lead technical projects meeting established deliverables.\n\u2022 Direct experience leading and/or performing failure analysis.\n\u2022 Effective communication skills and experience working with cross functional teams.\n\u2022 Excellent documentation writing skills; clear and concise using objective evidence and language.\n\u2022 Superior organizational skills including project management aptitude.\n\u2022 Energized attitude\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-05 19:58:22", "url": "http://jobs.sjm.com/xml/27668542/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Product Dvlpmnt Engineer", "reqid": "AF13825", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27668542}, {"country_short": "USA", "city": "Irvine", "description": "Principal Product Development Engineer\nJob Requisition #: AF13821\nDate Posted: 03/26/2012\nCategory: Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have:\n\u2022 Leads the design and process development of new products\n\u2022 Represents Product Development on cross functional product development teams\n\u2022 Applies engineering/ design/ process knowledge to the development of new products\n\u2022 Manages engineering and technician support assigned to the project\n\u2022 Develops schedules and timelines for project work and tracks to and updates\n\u2022 Authors designs control documentation including specifications, requirements, reports, and protocols\n\u2022 Provides engineering, design and technical support of products introduced currently in release.\n\nRequired Qualifications:\n\u2022 BS in Mechanical or Biomedical Engineering\n\u2022 10 + years experience in catheter based product design/ R&D in Medical Device industry\n\u2022 3+ years project leadership or management experience\n\u2022 Demonstrated knowledge of successful process development- process identification and process characterization\n\u2022 Track record of successful product transfer from Product Development to Manufacturing\n\u2022 Demonstrated ability to work with manufacturing to improve products and processes to increase yield(s)\n\u2022 Experience with medical design from initial concept generation to manufacturing\n\u2022 Strong analytical reasoning\n\u2022 Experience working within medical device regulatory systems (FDA Design Controls, ISO9001, GMP)\n\u2022 Polished communicator\n\u2022 Excellent documentation writing skills; clear and concise using objective evidence and language\n\u2022 Excellent reputation for building relationships\n\u2022 Organized, on-time, and detailed skills\n\u2022 Energized attitude\n\nPreferred Qualifications:\n\u2022 MathCAD experience\n\u2022 Knowledge of electrophysiology\n\u2022 Working knowledge of statistics\n\u2022 Experience w/Cardiac anatomy\n\u2022 Tissue ablation\n\u2022 Catheter design\n\nTo learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-26 20:58:00", "url": "http://jobs.sjm.com/xml/27398973/job", "country": "United States", "company": "St. Jude Medical", "title": "Principal Product Development Engineer", "reqid": "AF13821", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27398973}, {"country_short": "USA", "city": "Irvine", "description": "Senior Design Quality Engineer\nJob Requisition #: AF13715\nDate Posted: 03/13/2012\nCategory: Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have within the AF division:\n\u2022 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.\n\u2022 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.\n\u2022 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.\n\u2022 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.\n\u2022 Communicate any quality-related issues to Quality Management, propose and lead implementation of appropriate corrective actions. Prepare corrective action implementation project plan and schedule.\n\u2022 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.\n\nRequired Qualifications:\n\u2022 B.S. Engineering degree.\n\u2022 Extensive product and process validation experience.\n\u2022 Strong written and oral communication skills.\n\u2022 Successful track record of being organized, ability to prioritize, and working both independently and in teams.\n\u2022 Experience with new product development process through project completion under 21CFR Part 820 or Medical Device Directive regulations.\n\u2022 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).\n\u2022 7+ years of QA experience within the medical device industry.\n\u2022 Experience with MS Word, MS Excel, MS Visio, Minitab.\n\u2022 Great reputation for leading and driving change on multiple projects.\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings.\n\u2022 Excellent reputation for building relationships across various levels of an organization.\n\u2022 Organized, on-time, and detailed project management skills.\n\u2022 Energized attitude.\n\u2022 Ability to influence others without authority.\n\nPreferred Qualifications:\n\u2022 Preferred degrees are related to medical devices, such as Biomedical or Electrical Engineering degree.\n\u2022 CQE, CQA certification.\n\nTo learn more, visit our web site at www.sjm.com\nSt. Jude Medical is an equal opportunity employer.\n\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-13 23:44:27", "url": "http://jobs.sjm.com/xml/27117043/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Design Quality Engineer", "reqid": "AF13715", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27117043}, {"country_short": "USA", "city": "Irvine", "description": "Manufacturing Manager II\nJob Requisition #: AF13629\nDate Posted: 11/23/2011\nCategory: Manufacturing\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe 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.\n\nImpact this role will have within the AF division:\n\u2022 Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development.\n\u2022 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.\n\u2022 Maintains a strong customer focus.\n\u2022 Models optimum leadership competencies to inspire an energized, empowered and accountable work force.\n\u2022 Develops/monitors/controls budgets for multiple assigned areas and meets area financial objectives.\n\u2022 Cooperatively develops annual operational build and financial plans and over achievement/continuous improvement plans.\n\u2022 Determines resources to meet project objectives and manage budgets.\n\u2022 Forecasts and reports resource consumption area activity, performance and financial trends. Monitor/reduce inventory levels.\n\u2022 Develops production plans and initiates activity to meet production demand requirements and business needs.\n\u2022 Leads capital improvement projects and prepares capital expenditure requirements.\n\u2022 Conducts feasibility studies and develops project schedules.\n\u2022 Provide vision, strategies and tactics to ensure sustainable competitive advantage of assigned areas.\n\u2022 Maintains regular, reliable, and predictable attendance.\n\u2022 Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.\n\u2022 Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\n\u2022 Performs other essential functions and responsibilities as determined by the company from time to time.\n\nRequired Qualifications:\n\u2022 Bachelors Degree in Business, Engineering or Sciences.\n\u2022 7+ years of leadership experience in a high-volume, multi-product manufacturing environment.\n\u2022 Ability to learn, train, and follow good manufacturing practices (FDA/GMP's) and other applicable regulatory standards (i.e., ISO9000) and ensures operational compliance.\n\u2022 Solid people management skills, including demonstrated ability to coach, mentor and develop employees.\n\u2022 Solid communication, interpersonal, and motivational skills.\n\u2022 Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles.\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings\n\u2022 Excellent reputation for building relationships across various levels of an organization.\n\u2022 Organized, on-time, and detailed project management skills.\n\u2022 Energized attitude.\n\nPreferred Qualifications:\n\u2022 Experience leading and implementing lean manufacturing/Six Sigma and change initiatives.\n\u2022 Medical device industry experience.\n\u2022 Masters Degree in Business, Engineering or Sciences.\n\u2022 SAP.\n\nTo learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer.\n\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2011-11-23 16:26:07", "url": "http://jobs.sjm.com/xml/25029408/job", "country": "United States", "company": "St. Jude Medical", "title": "Manufacturing Manager II", "reqid": "AF13629", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 25029408}]