Position Description: Responsible for coordinating and executing the Medtronic site Verification and Validation (V&V) deliverables, for supplier transfers within the Supplier Optimization group (Transfer Office) under the Operations Innovation team. Assist with defining Quality Impact Level (QIL) of supplier qualified product. Design assembly and holding fixtures, coordinate supplier fabrication, and develop protocols, reports, process instructions, preventive maintenance plans, and calibration schedules. Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, European Union Medical Device Regulation (EU MDR), ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP). Responsible for the PPAP (Production Part Approval Process) for supplier provided goods. Leverage IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Utilize Minitab and associated statistical tools including TMV (Test Method Validation), Capability (Ppk / Tolerance Intervals), and SPC (Statistical Process Control). Responsible for providing Control Plans, Process Flow Maps, and PFMEA (Process Failure Mode and Effects Analysis). Coordinate the creation and approval of V&V protocols / reports to include top-level assembly or sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans. Leverage AGILE, SAP, and ERP system knowledge based on Medtronic Operating Unit/site requirements. Execute First Article Inspection activities and summation of results. Update all BOM (Bill of Material) structure within the appropriate QMS (Quality Mgmt. System). Relocation assistance is not available for this position. #LI-DNI. NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210 Basic Qualifications: Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a manufacturing or design engineer for medical devices, or, Bachelors’ Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and seven (7) years of experience as a manufacturing or design engineer for medical devices. Must possess at least five (5) years’ experience with each of the following: FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP; PPAP and IQ/OQ/PQ; Minitab, TMV, Capability (Ppk / Tolerance Intervals), and SPC; Control Plan, Process Flow Map, and PFMEA; Creation and approval of V&V protocols, reports for top-level assembly and sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans; AGILE, SAP, and ERP systems; Executing First Article Inspection activities and summation of results; and Updating BOM structure within QMS. The position is located at Medtronic, Inc., 4102 Southpoint Blvd, Jacksonville, FL 32216. Salary: $144,000 to $184,800 per year THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at myworkday.com/medtronic. Go to: Menu > Jobs Hub > Refer a Candidate The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Use this link to hyperlink https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic