Hybrid Extrusion Engineering Manager bei Biomerics LLC

Description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building.

We are seeking a technically proficient and hands-on Extrusion Engineering Manager to lead extrusion engineering efforts at our Brooklyn Park, MN facility. This role is responsible for supporting the development, validation, and production readiness of medical device tubing processes. The ideal candidate will have deep expertise in single, dual, and multi-lumen extrusion using medical-grade polymers such as Nylon, Pebax, Polyurethane, and Polyethylene. Reporting directly to the Sr. Director of Engineering – NPI, this role will focus on translating new designs into scalable extrusion processes, working cross-functionally to ensure robust manufacturability and regulatory compliance.

Responsibilities

• Interface directly with the commercial directors, engineering leaders and sales team to meet customer needs and lead the COE into the proper technical direction.

• Meet with customers to provide technical solutions and updates for projects.

• Lead daily operations and technical execution of extrusion engineering activities related to NPI programs.

• Develop, validate, and document extrusion processes through IQ/OQ/PQ phases, aligned with FDA and ISO 13485 requirements.

• Design and refine extrusion tooling for complex geometries, supporting rapid development timelines.

• Collaborate with the NPI team to transition extrusion processes into production with high reliability and yield.

• Provide technical feasibility assessments for new designs and customer requirements.

• Partner with project management, manufacturing, and quality to ensure efficient scale-up and launch readiness.

• Interface with customers to present technical capabilities, resolve challenges, and support program milestones.

• Contribute to quoting efforts by estimating process capability, tooling complexity, and development timelines.

• Support training and knowledge sharing with technicians and junior engineers.

• Drive continuous improvement in extrusion quality, throughput, and reliability.

Requirements

• Bachelor’s degree in Engineering, Polymer Science, or a related technical field.

• 5–8 years of experience in medical extrusion, preferably within an NPI or development setting.

• Demonstrated proficiency in developing and validating extrusion processes for regulated medical devices.

• Deep knowledge of polymer behavior, extrusion tooling, and downstream equipment.

• Strong documentation and problem-solving skills in a regulated manufacturing environment.

• Ability to collaborate effectively across engineering, manufacturing, quality, and customer-facing teams.

• Comfortable in cleanroom environments and experienced with ISO 13485 / FDA cGMP requirements.

Preferred Experience:

• Experience leading technical teams and providing technical solutions to customers.

• Experience with catheter or interventional product extrusions.

• Familiarity with lean manufacturing, Six Sigma, or DOE practices.

• Track record of successfully transitioning new processes from development to commercial production.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, Onsite Fitness Facility.

The salary estimates are estimates from this job board and not a guarantee from Biomerics salary range.

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.