Engineering Manager, Medical Extrusion & Process Validation

Biomerics; Brooklyn Park (MN); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Job summary

Biomerics in Brooklyn Park, MN is seeking an Engineering Manager to lead the Extrusion Engineering & Process Validation group, building and standardizing systems to transfer extrusion processes into manufacturing while meeting regulatory requirements.

The role combines hands-on technical leadership with mentoring, leading DOE studies, validation, and technology transfer in collaboration with Commercial, Quality, Manufacturing, and customers to ensure scalable, compliant medical tubing production.

Qualifications

• Bachelor’s degree in Engineering, Polymer Engineering, Materials Science, or related field.
• 8+ years of engineering experience in medical extrusion, catheter manufacturing, or regulated medical device development.
• 3+ years of engineering leadership experience managing technical teams and projects.
• Demonstrated success developing and validating manufacturing processes for regulated medical devices.
• Extensive knowledge of polymer processing, extrusion tooling, downstream equipment, and process optimization.
• Strong understanding of FDA Design Controls, Process Validation, and ISO 13485 requirements.
• Excellent communication and leadership skills with the ability to engage customers and executive leadership.

Responsibilities

• Lead the Extrusion Engineering team from concept through commercial production.
• Serve as the technical authority for extrusion process development for multi-lumen medical tubing.
• Develop robust extrusion processes using a range of polymers and materials.
• Lead process characterization studies using DOE, statistics and fundamentals.
• Design and optimize extrusion tooling to support complex catheter and medical device applications.
• Oversee validation activities: IQ/OQ/PQ, TMV, process capability studies.
• Partner with Commercial, Quality, Manufacturing, Program Management, and customers for successful launches.

Skills

Engineering leadership

Medical extrusion

Process development

DOE

Statistical analysis

Customer engagement

Regulatory compliance

Education

Bachelor's degree in Engineering, Polymer Engineering, Materials Science, or related

Tools

Extrusion tooling

Process validation tooling

Job description

Biomerics in Brooklyn Park, MN is seeking an Engineering Manager to lead the Extrusion Engineering & Process Validation group, building and standardizing systems to transfer extrusion processes into manufacturing while meeting regulatory requirements.

The role combines hands-on technical leadership with mentoring, leading DOE studies, validation, and technology transfer in collaboration with Commercial, Quality, Manufacturing, and customers to ensure scalable, compliant medical tubing production.