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