Principal Manufacturing Engineer

Medtronic • Jacksonville, FL

1d • Onsite

About The Position

Responsible for coordinating and executing 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 with defining the Quality Impact Level (QIL) of supplier-qualified products and is responsible for Production Part Approval Process (PPAP) activities for supplier-provided goods.

The position involves designing assembly and holding fixtures, coordinating supplier fabrication, and developing protocols, reports, process instructions, preventive maintenance plans, and calibration schedules. It requires working with government and industry regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP).

The engineer uses IQ, OQ, and PQ, as well as Minitab and statistical methods such as Test Method Validation (TMV), capability analysis (Ppk / tolerance intervals), and Statistical Process Control (SPC). The role also develops Control Plans, Process Flow Maps, and PFMEAs; coordinates V&V protocols and reports; performs First Article Inspection activities; and updates BOM structures in the appropriate Quality Management System (QMS). The position is located at Medtronic, Inc., 4102 Southpoint Blvd, Jacksonville, FL 32216. 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 each of the following: 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/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 Medtronic 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 products.
• Design assembly and holding fixtures and coordinate supplier fabrication.
• Develop protocols, reports, process instructions, preventive maintenance plans, and calibration schedules.
• Manage PPAP for supplier-provided goods.
• Use IQ, OQ, and PQ, along with Minitab and statistical tools including TMV, capability analysis (Ppk / tolerance intervals), and SPC.
• Provide Control Plans, Process Flow Maps, and PFMEAs.
• Coordinate creation and approval of V&V protocols and reports, including top-level assembly or sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans.
• Use AGILE, SAP, and ERP systems according to Medtronic Operating Unit/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
• Employee referral bonus program at the $1,000 level

What This Job Offers

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