St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 22:47:45.653187USAIrvineQuality 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/jobUSAMinnetonkaSoftware Quality Engineer II Job Requisition #: 12878 Date Posted: 05/01/2012 Category: Software Quality Control Engineering Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview The Software Quality Engineer II is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. This position focuses on testing and validation. Essential Functions: • Develop and conduct training of company personnel for the divisional software development and validation program. • Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. • Create and execute or direct software validation protocols traceable to system/software requirements. • Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. • Assist in the completion and maintenance of risk analysis, focused on software related risks. • Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. Qualifications: • BS degree in Engineering or Technical Field • 2-5 years Software Quality Engineering experience. • Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485 • Solid communication and interpersonal skills • Advanced computer skills, including statistical/data analysis and report writing skills • Advanced Information Technology and data mining skills. • Prior medical device experience preferred • ASQ CSQE certification desired |E-mail this position Submit Resume or C.V.2012-05-18 19:27:23United StatesSt. Jude MedicalMinnesota12878MNMinnetonka, MN28797887http://jobs.sjm.com/xml/28797887/jobUSADallasSr. Quality Systems Engineer Job Requisition #: NMD3196 Date Posted: 05/02/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Working without appreciable supervision. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Provides quality system engineering support to site functions to ensure sub-system implementation complies with the NMD quality system requirements and governing regulations. This includes ensuring that system changes do not have an adverse effect on other sub-systems abilities to meet their requirements. Provide project management duties of quality system improvement projects. Major, On-Going Responsibilities: • Collaborate with cross functional management teams to define or improve quality system processes • Determine if organizational units are performing their defined processes and procedures in compliance with the NMD quality system and governing regulations, document deficient conditions • Act as Lead to plan, report on, follow-up and close scheduled and unscheduled quality system projects. • Obtain and analyze objective evidence as a basis for preparing an informed, objective report on the compliance of the process, discuss deficiencies and recommend corrective action, as requested. • Evaluate, or assist in evaluating, the adequacy of the corrective action to improve deficient conditions. • Perform or assists in the performance of special reviews as requested Experience and Training: • Bachelors degree Quality Engineering or related discipline • 5-8 years of experience with quality systems engineering in a regulated (FDA) industry. • Knowledge of FDA CFR part 820, ISO 13485:2003, CMDCAS, AIMD • Project Management experience a plus • Excellent communication skills, including written, verbal and interpersonal • Excellent organization and administrative skills • Ability to work independently with minimal supervision • Takes initiative to perform tasks that benefit the organization Other Skills/Characteristics: Equipment: Computer keyboard; standard office equipment Working Conditions: Normal office environment |E-mail this position Submit Resume or C.V.2012-05-02 18:54:00United StatesSt. Jude MedicalTexasNMD3196TXDallas, TX28332987http://jobs.sjm.com/xml/28332987/jobUSAMinnetonkaSenior Engineer - Quality Job Requisition #: 13093 Date Posted: 05/01/2012 Category: Engineering Quality Location: Minnetonka - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka. Job Overview Position Summary: Senior Supplier Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Cardiovascular Division and regulatory requirements. Primary responsibility is for plastics commodities. Duties and responsibilities: • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits. • Manages development of supplied product inspection procedures and first article requirements. • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions. • Contributes to the development, maintenance and improvement of CVD supplier quality program policies, procedures and forms. • Evaluates and develops Supplied Data Agreement partnerships with suppliers. • Provides engineering guidance to CVD Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures. • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies. • Reviews and approves all supplied product drawings and component quality plans. • Works with Manufacturing engineering to assess and address purchased product issues. • Provides project direction, coaching, and mentoring for technical team personnel. • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements. • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews. • Contributes and participates in supplier performance reviews. • Participate in or lead teams in supporting Supplier Assurance program requirements (e.g., represent the Supplier Assurance function as a Core Team Member) • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement Minimum Qualifications: • BS degree in Engineering or Technical Field • 5+ years experience preferred • Previous Supplier Quality engineering experience and demonstrated use of Quality tools/methodologies. • Prior medical device experience preferred with detailed knowledge of FDA and ISO 13485 regulations • Plastics commodity expertise preferred (injection molding and extrusion) • Advanced computer skills, including statistical/data analysis and report writing skills • ASQ CQE and CQA certification preferred |E-mail this position Submit Resume or C.V.2012-05-01 19:14:54United StatesSt. Jude MedicalMinnesota13093MNMinnetonka, MN28305043http://jobs.sjm.com/xml/28305043/jobUSADallasQuality Engineer II Job Requisition #: NMD3188 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision: Supervision will be from Senior or Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:45:10United StatesSt. Jude MedicalTexasNMD3188TXDallas, TX28179860http://jobs.sjm.com/xml/28179860/jobUSADallasSenior Quality Engineer Job Requisition #: NMD3186 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead, coach, and mentor non-exempt and entry level exempt personnel • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Supervision will be from Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 5+ years experience • Demonstrated supervisory experience preferred • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:44:58United StatesSt. Jude MedicalTexasNMD3186TXDallas, TX28179857http://jobs.sjm.com/xml/28179857/jobUSADallasSenior Quality Engineer Job Requisition #: NMD3187 Date Posted: 04/25/2012 Category: Engineering Quality Location: Dallas - TX - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead, coach, and mentor non-exempt and entry level exempt personnel • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of Critical to Quality parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Supervision will be from Principal Quality Engineers or Quality Manager Relationships: Internal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development External: Suppliers Equipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems. Working Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning. Physical Demands: Average eye-sight, ability to lift 20 lbs Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 5+ years experience • Demonstrated supervisory experience preferred • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-25 19:44:58United StatesSt. Jude MedicalTexasNMD3187TXDallas, TX28179858http://jobs.sjm.com/xml/28179858/jobUSAWestfordEngineer Principal - Quality Job Requisition #: 13060 Date Posted: 04/20/2012 Category: Process Development Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support. Essential Functions: • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel. • Leads multifunctional teams in completing program directed or continuous improvement activities. • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Expected to independently and effectively make data based decisions with respect to individual and project team deliverables. Able to independently perform core team member role. Able to manage and mentor technicians and lower levels of engineering. Qualifications: • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred • 10+ years experience • Demonstrated supervisory experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Demonstrates technical leadership within the department and outside the department • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-20 18:08:30United StatesSt. Jude MedicalMassachusetts13060MAWestford, MA28034677http://jobs.sjm.com/xml/28034677/jobUSAScottsdaleSenior Quality Engineer Job Requisition #: 13049 Date Posted: 04/19/2012 Category: Quality Location: Scottsdale - AZ - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Scottsdale, Arizona: Job Overview This is an exciting opportunity for a skilled quality engineer who is interested in building life saving devices while interacting with multiple sites across the U.S. and globally. Working within a small team, within the first 6 months on the role, the Senior QA engineer will come up to quick speed on the daily component and process issues that happen within the hybrid build process while providing guidance to the inspectors on visual criteria interpretation. On a long term basis, the expectation is to have the engineer be fully integrated in the hybrid manufacturing culture while participating in activities and investigations related to our customers at other manufacturing sites (Sylmar, Puerto Rico, Malaysia and South Carolina). Will work closely with Engineering to define hybrid acceptance criteria for new components/ products; to create Quality plans for new products Requirements/Education: Bachelors Degree in Electrical or Mechanical Engineering. Minimum 5years of QA experience, working directly on a microelectronics manufacturing environment, solving day to day problems and dealing with people at all levels of the organization. Broad cross-disciplinary and in-depth knowledge of the quality engineering profession. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering quality engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required. |E-mail this position Submit Resume or C.V.2012-04-19 18:48:23United StatesSt. Jude MedicalArizona13049AZScottsdale, AZ28008616http://jobs.sjm.com/xml/28008616/jobUSANoneSenior Quality Engineer Job Requisition #: 12975 Date Posted: 04/13/2012 Category: Production Location: Arecibo - - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD): Job Overview This position has a dual purpose (1) to ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing failures, complaints, defect reports, and audit findings in order to coordinate corrective action and (2) perform internal and vendor/supplier audits to determine such compliance. This position will have responsibility for quality compliance for all products produced in the SJM-PRLLC facility. This position works with minimum supervision and has appreciable latitude for interviewed actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion. Requirements/Education: Bachelors degree in Engineering required, advanced degree or process towards advanced degree is a plus. Must have 4+ years experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry. Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP, auditing principals, and contamination control. Prior experience auditing FDA regulations preferred. Must be bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines. Credentials of a Certified Quality Engineer are a plus. Must be able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:42United StatesSt. Jude MedicalNone12975NoneVirtual, USA27883013http://jobs.sjm.com/xml/27883013/jobUSASt. PaulPrincipal Quality Engineer Job Requisition #: 12790 Date Posted: 04/02/2012 Category: Engineering Location: St. Paul - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul: Job Overview The Principal Quality Engineer is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within manufacturing and system/services support. Requirements: • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel • Leads multifunctional teams in completing program directed or continuous improvement activities • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 8+ years experience • Demonstrated supervisory experience • Engineering experience and demonstrated use of Quality tools/methodologies • Must have experience with commercializing / validating new products • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Demonstrates technical leadership within the department and outside the department • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-03 03:22:30United StatesSt. Jude MedicalMinnesota12790MNSt. Paul, MN27603034http://jobs.sjm.com/xml/27603034/jobUSAWestfordEngineer - Quality Job Requisition #: 12635 Date Posted: 03/30/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-03-31 03:43:28United StatesSt. Jude MedicalMassachusetts12635MAWestford, MA27532236http://jobs.sjm.com/xml/27532236/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/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/jobUSAWestfordEngineer - Quality Job Requisition #: 12565 Date Posted: 02/24/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-27 23:58:45United StatesSt. Jude MedicalMassachusetts12565MAWestford, MA26798151http://jobs.sjm.com/xml/26798151/jobUSAWestfordEngineer II - Quality Job Requisition #: 12344 Date Posted: 02/21/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within remanufacturing/Service Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-21 21:40:43United StatesSt. Jude MedicalMassachusetts12344MAWestford, MA26658112http://jobs.sjm.com/xml/26658112/job