Principal Manufacturing Engineer
About The Position
The Principal Manufacturing Engineer will coordinate and execute Medtronic site Verification and Validation (V&V) deliverables for supplier transfers within the Supplier Optimization group (Transfer Office) under the Operations Innovation team. The role assists in defining the Quality Impact Level (QIL) of supplier-qualified product, designs assembly and holding fixtures, coordinates supplier fabrication, and develops protocols, reports, process instructions, preventive maintenance plans, and calibration schedules. The position applies applicable government and industry regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and Good Manufacturing Practices. It is responsible for PPAP for supplier-provided goods and uses IQ, OQ, and PQ, along with Minitab and statistical methods such as TMV, capability analysis (Ppk / tolerance intervals), and SPC. The engineer provides Control Plans, Process Flow Maps, and PFMEA; coordinates the creation and approval of V&V protocols and reports; and determines test acceptance criteria, sample sizes based on component or feature criticality, and sampling plans. The role also uses AGILE, SAP, and ERP systems according to operating-unit and site requirements; executes First Article Inspection activities and summarizes results; and updates BOM structures within the appropriate QMS. The position is based in Jacksonville, Florida. Relocation assistance is not available. The application window is anticipated to close on December 31, 2026.
Requirements
- Master’s degree in Mechanical, Industrial, or Biomedical Engineering, or a related engineering field, and five years of experience as a manufacturing or design engineer for medical devices; alternatively, a bachelor’s degree in one of these fields or a related engineering field and seven years of such experience.
- At least five years of experience with FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and GMP.
- At least five years of experience with PPAP and IQ/OQ/PQ.
- At least five years of experience with Minitab, TMV, capability analysis (Ppk / tolerance intervals), and SPC.
- At least five years of experience with Control Plans, Process Flow Maps, and PFMEA.
- At least five years of experience creating and approving V&V protocols and reports, including top-level assembly and sub-assembly test acceptance criteria, sample sizes based on component or feature criticality, and sampling plans.
- At least five years of experience with AGILE, SAP, and ERP systems.
- At least five years of experience executing First Article Inspection activities and summarizing results.
- At least five years of experience updating BOM structures within QMS.
Responsibilities
- Coordinate and execute site V&V deliverables for supplier transfers within the Supplier Optimization group (Transfer Office) under the Operations Innovation team.
- Assist in defining the Quality Impact Level (QIL) of supplier-qualified product.
- Design assembly and holding fixtures and coordinate supplier fabrication.
- Develop protocols, reports, process instructions, preventive maintenance plans, and calibration schedules.
- Apply relevant regulations and standards, including FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and GMP.
- Manage PPAP for supplier-provided goods and leverage IQ, OQ, and PQ.
- Use Minitab and statistical tools for TMV, capability analysis (Ppk / tolerance intervals), and SPC.
- Provide Control Plans, Process Flow Maps, and PFMEA.
- Coordinate creation and approval of V&V protocols and reports, including test acceptance criteria, sample sizes based on component or feature criticality, and sampling plans.
- Use AGILE, SAP, and ERP systems in accordance with Medtronic operating-unit and site requirements.
- Execute First Article Inspection activities and summarize results.
- Update BOM structures within the appropriate QMS.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps global well-being program
- Incentive plans
- 401(k) plan with 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
- Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums
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What This Job Offers
Job Type
Full-time
Career Level
Principal
