Manufacturing Engineer
JCW Group
Posted: 29/05/2026 Location: Maple Grove, Minnesota, United States Job type: Contract
Senior/Principal Manufacturing Engineer - Catheter Production | Contract | Northwest Metro
We are partnered with a leading medical device contract manufacturer to identify an experienced Senior or Principal Manufacturing Engineer for a 6-month contract engagement. This position is supporting an active commercial catheter manufacturing operation and is expected to begin as soon as the right candidate is identified.
Our client operates high-volume catheter production lines supporting multiple customers across active commercial and clinical programs. This is a backfill role covering a senior team member on leave, and the expectation is that the selected candidate integrates quickly and contributes from day one. This is a hands-on, floor-present position - not a documentation or project management role. What You Will Be Doing
- Providing day-to-day manufacturing engineering support across high-volume catheter production lines including process troubleshooting, yield improvement, and line-down resolution
- Investigating and dispositioning nonconformances and process deviations; initiating and driving CAPAs through closure
- Owning and executing process validation activities (IQ/OQ/PQ) and supporting process changes through applicable change control workflows
- Authoring and revising manufacturing procedures, work instructions, and process documentation to reflect current state
- Collaborating cross-functionally with quality, operations, and production teams to maintain regulatory compliance
- Serving as a senior technical resource for production technicians and operators on the floor
- 10 or more years of manufacturing engineering experience in a regulated medical device environment
- Direct, hands-on experience with high-volume catheter manufacturing processes such as extrusion, braiding, tipping, bonding, UV adhesive assembly, reflow, or end-of-line testing
- Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820
- Demonstrated ability to troubleshoot process and equipment issues independently and drive them to resolution without significant oversight
- Proven experience authoring and executing IQ/OQ/PQ validation protocols
- Prior experience in a CDMO or contract manufacturing environment supporting multiple OEM customers is strongly preferred
- Location: Northwest Metro - fully on-site, 5 days per week
- Duration: 6-month contract
- Compensation: $50-$70/hr W2 depending on experience
Resumes are being reviewed as they are received. Apply Now
Vacancy posted 2 days ago
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