Domico Med-Device LLC
Fenton, MI
JOB SUMMARY Lead contract manufacturing projects from concept through production, ensuring robust process design, manufacturability, and ongoing improvement. Support production teams, drive continuous improvement, maintain compliant documentation, and collaborate directly with customers and cross-functional teams. Ensure all processes and specifications meet QMS, FDA 21 CFR Part 820, and ISO 13485 requirements. PRINCIPLE RESPONSIBILITIES AND RESULTS Contract Design & Development Lead design and development for OEM/contract manufacturing projects. Manage prototypes, first articles, design risk mitigation, and product testing. Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs). Verify design outputs vs. inputs and support quality planning. Lead project timelines, milestones, and cross-functional meetings. Contract Manufacturing Lead (OEM projects) Evaluate new or revised product designs for manufacturability and...
