Principal Manufacturing Engineer

Medtronic • Jacksonville, FL

1d • Onsite

About The Position

Medtronic is hiring a Principal Manufacturing Engineer in Jacksonville, Florida, to coordinate and execute site Verification and Validation (V&V) deliverables for supplier transfers within the Supplier Optimization group (Transfer Office), part of the Operations Innovation team. The role assists in defining the Quality Impact Level (QIL) of supplier-qualified product and is responsible for the Production Part Approval Process (PPAP) for supplier-provided goods.

The engineer designs assembly and holding fixtures; coordinates supplier fabrication; and develops protocols, reports, process instructions, preventive maintenance plans, and calibration schedules. The role applies relevant regulations and standards, including FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and Good Manufacturing Practices. It uses IQ, OQ, and PQ, along with Minitab and statistical methods such as Test Method Validation (TMV), capability analysis (Ppk/tolerance intervals), and Statistical Process Control (SPC).

The position also provides Control Plans, Process Flow Maps, and PFMEA; coordinates creation and approval of V&V protocols and reports, including test acceptance criteria, sample sizes based on component or feature criticality, and sampling plans; uses AGILE, SAP, and ERP systems according to site requirements; executes and summarizes First Article Inspections; and updates Bill of Material (BOM) structures within the appropriate Quality Management System (QMS). Relocation assistance is not available.

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; or a bachelor’s degree in one of those fields 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 a 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 with 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.
• Manage the PPAP process for supplier-provided goods.
• Use IQ, OQ, and PQ, and apply statistical tools and methods including TMV, capability analysis, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal