Senior Manufacturing Engineer
Domico Med Device LLC•Fenton, MI
•$100,000 - $110,000•Hybrid
About The Position
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.
Requirements
- Bachelor’s in Mechanical or Industrial Engineering (or equivalent experience).
- 5+ years in manufacturing/mechanical engineering and product development.
- Strong SolidWorks/EPDM skills; ERP experience (Global Shop preferred).
- Lean familiarity and strong analytical/problem‑solving skills.
- Excellent communication and documentation skills.
- Highly organized, quality‑focused, and collaborative.
Nice To Haves
- Medical device experience.
- CNC programming experience.
- Technical writing experience.
- Compression Molding experience.
Responsibilities
- 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.
- Evaluate new or revised product designs for manufacturability and process fit.
- Work with OEM engineers to refine requirements and ensure production feasibility.
- Develop, validate, and document production processes for repeatability and efficiency.
- Design/validate tools, fixtures, molds, and work instructions.
- Conduct PFMEAs, process capability studies, and prototype builds.
- Train production personnel on new processes.
- Support and lead where required assessment and qualifications of suppliers.
- Support and lead where required sourcing and qualification of materials.
- Apply Lean principles to reduce waste and improve efficiency.
- Lead/participate in root‑cause investigations and corrective actions.
- Develop error‑proofing tools, test new materials, and assess ROI for improvements.
- Implement changes through Change Control and CAPA.
- Resolve production issues, review documentation, and initiate updates.
- Participate in NCR/MRB activities and help define acceptance criteria.
- Represent Domico with professionalism
- Travel as needed (domestic and international)
- Champion Domico Med-Device, LLC vision, purpose, and values
- All other duties, as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
