Manufacturing Engineer

Manufacturing Transfer Engineer Location: Salt Lake City, UT (Onsite) Duration: 12-Month Contract | W2 Only Travel: Costa Rica as needed (Expenses Paid) Job Description: Seeking a Manufacturing Transfer Engineer with 6+ years of medical device manufacturing experience to support manufacturing transfers, technology transfer, and product line duplication across Contract Manufacturing Organizations (CMOs). The ideal candidate will have hands-on experience with IQ/OQ/PQ, equipment qualification, Design Transfer, Design Controls, ECOs, Change Control, CAPA, FMEA, and manufacturing scale-up while ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and GMP. Must-Have Skills Manufacturing Transfer Technology Transfer Contract Manufacturing (CMO) Product Line Duplication Manufacturing Readiness Process Validation (IQ/OQ/PQ) Equipment Qualification Design Transfer Design Controls Engineering Change Orders (ECO) Change Control CAPA Deviations FMEA / Risk Management Manufacturing Scale-Up New Product Introduction (NPI) FDA 21 CFR Part 820 ISO 13485 GMP Lean Manufacturing Six Sigma Root Cause Analysis SAP / Oracle (Preferred) PLM Systems (Preferred) Cross-Functional Collaboration