Job Title: Validation Engineer
Location: Kalamazoo, MI (Onsite M-F, 8am-5pm)
Duration: 6+ month W2 contract
Overview:
We are seeking a skilled Process Engineer with medical device experience to join our team. The ideal candidate will have expertise in process validation, production part approval, and vendor management, particularly in electro-mechanical projects with embedded software.
Key Responsibilities:
- Process Validation: Validate entire manufacturing assembly processes, including the development of pFMEA, Risk Analysis, and Process Control Plans.
- Production Part Approval: Collaborate with vendors to ensure parts meet specifications and define processes for consistent part production.
- Supplier/Vendor Management: Manage and work closely with external vendors to procure parts and ensure they meet quality standards.
- Project Management: Contribute to or manage electro-mechanical projects with embedded software.
- Process Development: Engage in process development activities and program management.
Required Qualifications:
- 5 years in process engineering, ideally in medical devices or regulated industries (pharma, automotive, aerospace).
- Experience working with PPAP, pFMEA, EQ, OP, PQ, change controls processes, and risk analysis.
- Experience with pressure leak systems and plastics joining/welding is a plus.
