Lead Extrusion Engineer

Location: Brooklyn Park, MN
Salary: $130,000–$150,000 + bonus

About the Role

We are seeking an Extrusion Engineer to serve as the technical authority for a growing medical extrusion operation. This role is ideal for a senior engineer who wants to expand into leadership responsibilities without moving into a traditional management position. While this position includes oversight of one engineer, the primary focus remains technical leadership, customer engagement, process development, and operational excellence.

The successful candidate will be a key member of a small, highly collaborative team and will play a critical role in developing new products, improving manufacturing processes, and supporting customer programs from concept through commercialization.

Responsibilities

• Serve as the site's technical subject matter expert for medical extrusion.
• Lead process development, optimization, and troubleshooting efforts.
• Develop and execute process characterization studies and Design of Experiments (DOE).
• Lead and support process validation activities, including OQ and PQ protocols.
• Drive New Product Introduction (NPI) projects from development through production launch.
• Interface directly with customers to support technical discussions, development programs, and project execution.
• Provide mentorship, guidance, and technical oversight to one extrusion engineer.
• Collaborate closely with operators, technicians, quality engineers, and manufacturing personnel.
• Develop tooling, systems, standards, and documentation that improve operational performance.
• Lead root cause investigations and implement sustainable corrective actions.
• Support project coordination activities across engineering, quality, and operations.

Requirements

• Bachelor's degree in Engineering or related technical discipline.
• Direct experience operating, setting up, troubleshooting, or developing extrusion processes. (Required)
• Strong background in OQ/PQ execution and process validation within a regulated environment.
• Experience conducting process characterization studies and DOE analysis.
• Demonstrated success supporting customer-facing engineering projects.
• Strong technical problem-solving and communication skills.
• Ability to influence cross-functional teams and lead through technical expertise.

Preferred Qualifications

• Experience with:
  • Single-lumen tubing
  • Multi-lumen tubing
  • Bump tubing
  • Tight-tolerance medical tubing
• Experience working with tubing diameters ranging from approximately 0.015" to 0.350".
• Prior experience as an Extrusion Technician, Process Engineer, Manufacturing Engineer, or Senior Extrusion Engineer.
• Experience supporting medical device product development and NPI programs.
• Informal leadership, mentoring, or supervisory experience.

Benefits

• Leadership-track opportunity without moving away from engineering.
• Direct influence on technology, process development, and customer success.
• High visibility with leadership and customers.
• Opportunity to mentor and develop another engineer.
• Small, collaborative team environment where your expertise will have an immediate impact.
• Significant involvement in new product development and advanced medical extrusion applications.
• Flexible paid time off policy with approximately five weeks commonly utilized.
• Competitive compensation package including bonus opportunity.