Principal Quality Engineer

Division: Cardiovascular Division (CVD) Location: Maple Grove, MN 55311 Status: Full Time, Employee Job Category: Engineering Career Level:Experienced (Non-Manager) Company:St. Jude Medical Principal Quality Engineer PRIMARY FUNCTION:  A Design Assurance Engineer works closely with development/manufacturing engineering to establish/ensure compliance with the quality system. He/she works closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance.  He/she establishes/monitors quality assurance efforts to ensure that the company’s products conform to quality standards.  He/she works with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes.  The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.NORMAL QUALIFICATIONS (EDUCATION and/or EXPERIENCE) Four year degree in technical field, preferably mechanical/industrial quality engineering. Minimum of five (5) years experience in medical device engineering or quality assurance.  Good oral and written communication skills.  TYPICAL DUTIES AND RESPONSIBILITIES 1. Perform leadership role for Quality function as core team member on new product development projects. 2. Ensure company’s adherence to the established Quality System and GMP/ISO standards. 3. Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product specifications. 4. Select or design test equipment as required to accomplish quality responsibilities. 5. Develops and documents test plan protocols, test procedures, and test reports. 6. Perform tests according to various protocol requirements. 7. Lead completion of risk analysis including FMECA. 8. Devise design verification plans for products based on performance specifications and risk analysis. 9. Use decision-making authority to determine conformance to specifications and standards. 10. Conducts technical and statistical investigations concerning compliance to specification. 11. Assist in definition and completion of in vitro testing including applicable animal studies. 12. Assist in defining and measuring process capability, process controls, and process validation. 13. Aide in definition of supplier quality specifications, sampling plans, and vendor qualification. 14. Lead in definition and qualification of sterilization processes. 15. Perform other duties and responsibilities as assigned by senior management.PHYSICAL DEMANDS/WORK ENVIRONMENT The physical demands expected are typical of an exempt employee.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If you are interested in exploring this job opportunity with St. Jude Medical, visit “Careersâ€� on our website at www.sjm.com and apply to requisition 8676 or click apply now.Apply Now! St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.