St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 22:49:15.318215USAMinnetonkaSoftware 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/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/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/job