Principal Manufacturing Engineer

Principal Manufacturing Engineer at Medtronic in Jacksonville, FL, responsible for coordinating verification and validation deliverables for supplier transfers, designing fixtures, and ensuring compliance with FDA, EU MDR, and ISO regulations in medical device manufacturing.

Responsibilities

• Coordinate and execute site verification and validation deliverables for supplier transfers
• Design assembly and holding fixtures, coordinate supplier fabrication, and develop protocols and process instructions
• Develop preventive maintenance plans, calibration schedules, and ensure regulatory compliance
• Create and approve V&V protocols with test acceptance criteria, sample sizes, and sampling plans
• Execute First Article Inspection activities and maintain bill of material structures in quality management systems

Requirements

• Master's degree in Mechanical, Industrial, or Biomedical Engineering plus 5 years medical device manufacturing or design experience
• Bachelor's degree in Mechanical, Industrial, or Biomedical Engineering plus 7 years medical device manufacturing or design experience
• 5+ years experience with FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP
• 5+ years experience with PPAP, IQ/OQ/PQ protocols and execution
• 5+ years experience with Minitab, TMV, capability analysis, and statistical process control
• 5+ years experience developing control plans, process flow maps, PFMEA, and V&V protocols
• 5+ years experience with AGILE, SAP, and ERP systems; First Article Inspection; and BOM management

Compensation: $144,000–$184,800 per year