Location:

Plymouth, MN (On-Site)

Employment Type:

Full-Time Schedule:

Monday

•Friday, 8:00 AM

•5:00

PM Compensation:

$100,000

•$150,000 / year (commensurate with experience) Position Overview The Senior Extrusion Engineer serves as the technical subject matter expert (SME) and operational authority for a high-precision medical extrusion operation. In this hands-on, site-based role, you will take the lead in advancing extrusion engineering functions—troubleshooting and validating processes, spearheading continuous improvement initiatives, executing capital equipment projects, and expanding technical capabilities. Working collaboratively with cross-functional value-stream teams, internal toolmakers, and external precision machine shops, you will design tooling, evaluate new business opportunities, and mentor technicians and junior engineers to sustain a world-class manufacturing standard.

Key Responsibilities Process Development & Optimization:

Troubleshoot, refine, stabilize, and optimize melt extrusion lines and plastic component manufacturing processes. Validation (IQ/OQ/PQ/TMV): Author, execute, and analyze comprehensive validation protocols independently; guide technicians and supporting engineers through execution.

Tooling & Fixture Design:

Collaborate with internal and external machine shops to specify, design, and implement custom tooling and fixtures for new product introductions (NPI) and process improvements.

Continuous Improvement & Scrap Reduction:

Lead Lean Six Sigma projects aimed at driving down scrap, boosting throughput, improving line ergonomics/safety, and increasing overall profitability.

Project & Strategy Management:

Prioritize engineering projects, contribute to strategic operational planning, and evaluate capital equipment investments.

Technical Mentorship:

Serve as the extrusion SME for manufacturing technicians and operators, providing on-the-floor guidance, troubleshooting expertise, and technical training.

Cross-Functional Collaboration:

Actively participate in daily Value Stream alignment meetings, report out on key engineering deliverables, and support product transfers from development to commercial-scale manufacturing.

Qualifications & Experience Required:

Education:

Bachelor's degree in Engineering (Plastics Engineering, Mechanical Engineering, Chemical Engineering, or related discipline).

Experience:

5+ years of hands-on engineering experience in an extrusion manufacturing environment, preferably within medical device or regulated manufacturing.

Quality & Regulatory:

Strong working knowledge of

FDA 21 CFR

Part 820 / ISO 13485 regulations, GMP practices, and Design Controls.

Process Validation:

Demonstrated track record executing IQ/OQ/PQ and Test Method Validations (TMV).

Design & Metrology:

Working knowledge of Geometric Dimensioning and Tolerancing (GD&T) and proficiency with SolidWorks or comparable 3D CAD platforms.

Statistical Methods:

Solid foundation in Statistical Process Control (SPC), process capability analysis, and design of experiments (DOE), with proficiency in Minitab.

Communication & Collaboration:

Excellent technical writing and oral communication skills, with proven ability to generate clear, rigorous manufacturing specifications and work instructions.

Preferred:

Master's degree or BS specifically in Plastics Engineering. Direct experience developing complex, multi-lumen tubing tooling and tight-tolerance micro-extrusion processes. Lean Six Sigma Green Belt or Black Belt certification. Familiarity with secondary manufacturing and assembly processes, such as RF tipping/welding, injection molding, medical wire braiding, centerless grinding, and catheter assembly. Experience utilizing Microsoft Project and Visio.

Location:

Plymouth, MN (On-Site)

Employment Type:

Full-Time Schedule:

Monday

•Friday, 8:00 AM

•5:00

PM Compensation:

$100,000

•$150,000 / year (commensurate with experience) Position Overview The Senior Extrusion Engineer serves as the technical subject matter expert (SME) and operational authority for a high-precision medical extrusion operation. In this hands-on, site-based role, you will take the lead in advancing extrusion engineering functions—troubleshooting and validating processes, spearheading continuous improvement initiatives, executing capital equipment projects, and expanding technical capabilities. Working collaboratively with cross-functional value-stream teams, internal toolmakers, and external precision machine shops, you will design tooling, evaluate new business opportunities, and mentor technicians and junior engineers to sustain a world-class manufacturing standard.

Key Responsibilities Process Development & Optimization:

Troubleshoot, refine, stabilize, and optimize melt extrusion lines and plastic component manufacturing processes. Validation (IQ/OQ/PQ/TMV): Author, execute, and analyze comprehensive validation protocols independently; guide technicians and supporting engineers through execution.

Tooling & Fixture Design:

Collaborate with internal and external machine shops to specify, design, and implement custom tooling and fixtures for new product introductions (NPI) and process improvements.

Continuous Improvement & Scrap Reduction:

Lead Lean Six Sigma projects aimed at driving down scrap, boosting throughput, improving line ergonomics/safety, and increasing overall profitability.

Project & Strategy Management:

Prioritize engineering projects, contribute to strategic operational planning, and evaluate capital equipment investments.

Qualifications & Experience Required:

Education:

Bachelor's degree in Engineering (Plastics Engineering, Mechanical Engineering, Chemical Engineering, or related discipline).

Experience:

5+ years of hands-on engineering experience in an extrusion manufacturing environment, preferably within medical device or regulated manufacturing.

Quality & Regulatory:

Strong working knowledge of

FDA 21 CFR

Part 820 / ISO 13485 regulations, GMP practices, and Design Controls.

Process Validation:

Demonstrated track record executing IQ/OQ/PQ and Test Method Validations (TMV).

Design & Metrology:

Working knowledge of Geometric Dimensioning and Tolerancing (GD&T) and proficiency with SolidWorks or comparable 3D CAD platforms.

Statistical Methods:

Solid foundation in Statistical Process Control (SPC), process capability analysis, and design of experiments (DOE), with proficiency in Minitab.

Communication & Collaboration:

Excellent technical writing and oral communication skills, with proven ability to generate clear, rigorous manufacturing specifications and work instructions.

Preferred:

Master's degree or BS specifically in Plastics Engineering. Direct experience developing complex, multi-lumen tubing tooling and tight-tolerance micro-extrusion processes. Lean Six Sigma Green Belt or Black Belt certification. Familiarity with secondary manufacturing and assembly processes, such as RF tipping/welding, injection molding, medical wire braiding, centerless grinding, and catheter assembly. Experience utilizing Microsoft Project and Visio.

Technical Mentorship:

Serve as the extrusion SME for manufacturing technicians and operators, providing on-the-floor guidance, troubleshooting expertise, and technical training.

Cross-Functional Collaboration:

Actively participate in daily Value Stream alignment meetings, report out on key engineering deliverables, and support product transfers from development to commercial-scale manufacturing. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.