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.

About the Opportunity

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

What We Are Looking For

• 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

Engagement Details

• 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.