Contract | Hybrid | Maple Grove, MN

Supplier Engineer – Medical Device (Contract)

Life Sciences · Quality & Engineering

We’re seeking a driven Supplier Engineer to lead critical remediation activities for contract-manufactured finished medical devices. This is a high-impact, cross-functional role where you’ll own supplier process validation reviews, collaborate with internal engineering and quality teams, and work directly with 10–20 contract manufacturers to close compliance gaps. If you’re hands-on, solutions-oriented, and not afraid to pick up the phone — we want to hear from you.
 

What you’ll do

• Review, remediate, and approve supplier process risk documentation (PFMEA) against newly defined criteria
• Evaluate and approve supplier process and inspection validations (IQ/OQ/PQ/TMV) to statistical requirements
• Execute change management activities to close gaps in supplier documentation and validations
• Partner cross-functionally with supplier engineering, quality engineering, and contract manufacturers to drive remediation to completion
• Operate independently as the lead for remediation activities across all applicable contract manufacturers
• Uphold patient safety and product quality in all actions

Required qualifications

• Bachelor’s degree in Engineering
• 1–2 years of experience in a manufacturing environment (operational experience preferred over design)
• Hands-on experience with IQ, OQ, PQ, and test method validation (TMV)
• Ability to travel up to 15% (primarily domestic)
• Must be local to Minnesota — no relocation assistance available
• Must be authorized to work in the U.S. without current or future visa sponsorship

Preferred qualifications

• Experience in medical device or regulated manufacturing
• Background working with suppliers or in supply chain management
• Strong project management and communication skills
• Familiarity with statistical methods, Six Sigma, or structured problem-solving methodologies
• Self-motivated with a strong bias for action

Important: W2 engagement only — Corp-to-Corp (C2C) arrangements will not be accepted. Candidates requiring visa sponsorship now or in the future will not be considered.