Permanent position: Leading Medical Device Manufacturer is seeking a Sr. Process Development Engineer in South Florida. The Engineer will determine operations to produce products and develop processes to ensure quality, cost and efficiency requirements. You will also lead and manage key process items to bring new products through the design phase into efficient manufacturing operations. Relocation provided for qualified candidate.
Responsibilities for the Senior Process Engineer• Determine operations to produce products and develop processes to ensure quality, cost and efficiency requirements
• Lead and manage key process items to bring new products through the design phase into efficient manufacturing operations.
• Develop and implement new Mfg processes, execute process validations such as IQ, OQ, PQ protocols and reports
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Perform statistical analyses on data groups
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc
Requirements for the Senior Process Engineer• 4 year engineering degree (B.S. in Engineering) or equivalent experience
• 6+ years of experience in a technical role in the medical device industry
• Project management experience in the medical device industry
• Experience and understanding of quality system regulations (21CFR820, ISO13485).
• Experience with polymers, medical grade metals and medical packaging
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes