Senior Extrusion Engineer (Medical Device)

TL;DR

Senior Extrusion Engineer (Medical Device): Serving as the extrusion subject matter expert for high-volume manufacturing processes with an accent on process stability, yield optimization, and long-term equipment strategy. Focus on driving continuous improvement, leading process validations (IQ/OQ/PQ), and solving complex technical challenges to ensure high-quality medical device production.

Location: Must be based onsite in Plymouth, Minnesota

Salary: $100,000–$150,000

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Serve as the technical owner for extrusion processes, ensuring stable and capable manufacturing operations.
• Define and execute long-term strategies for equipment, tooling, and process controls.
• Lead validation and revalidation efforts (IQ/OQ/PQ) for process changes and capacity expansions.
• Resolve complex extrusion issues on the shop floor, performing root cause analysis and implementing corrective actions.
• Drive continuous improvement initiatives to enhance yield, reduce scrap, and optimize costs.
• Mentor engineers and technicians to elevate overall technical capability across the facility.

Requirements

• Bachelor's degree with 4+ years of relevant experience OR Master's degree with 2+ years of experience OR PhD with 0 years of experience.
• Must be based onsite 5 days a week in Plymouth, MN.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Background in a regulated manufacturing environment such as FDA or ISO 13485.
• Proven ability to perform technical root cause analysis and lead process validations.
• Proficiency in process characterization and data-driven optimization tools.

Nice to have

• Experience with medical-grade polymer extrusion (multi-lumen or tight-tolerance tubing).
• Proficiency with SPC, DOE, and Lean/Six Sigma methodologies.
• Experience with extrusion equipment lifecycle management and obsolescence planning.
• Strong background in supplier qualification and technical collaboration.

Culture & Benefits

• Competitive salary with short-term incentive plans (MIP).
• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) retirement plan with employer contribution and match.
• Paid time off, paid holidays, and short-term/long-term disability.
• Employee Stock Purchase Plan and tuition assistance programs.
• Commitment to professional growth, cross-functional collaboration, and patient-first values.