Process Development Engineer I-Ii

Judge GroupOsseo, MN

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Job Description

Location: Osseo, MNDescription:

Job Title:Senior / Principal Process Development Engineer – Balloon Catheter

Location: Maple Grove 55369

Summary:A senior-level process development engineer role focused on the development, scale-up, validation, and transfer of balloon catheter manufacturing processes from early feasibility through commercial production. The position serves as a technical leader and subject-matter expert for balloon catheter technologies, working cross-functionally with design engineering, operations, quality, suppliers, and clients to deliver robust, scalable, and compliant manufacturing solutions. The role combines hands-on engineering, equipment development, automation exposure, and technical leadership within a regulated medical device environment.

Required / Mandatory Skills:

Hands-on balloon catheter process development and manufacturing experience
Balloon forming, bonding, shaft assembly, tipping, welding, and secondary operations
Design for Manufacturability (DFM) collaboration with product/design engineering
Process development, optimization, and scale-up from prototype to production transfer
Equipment and process specification development (URS, equipment specs, process flows)
FAT, SAT, IQ, OQ, PQ, and process characterization execution
Statistical tools: DOE, SPC, capability studies, hypothesis testing
Medical device regulated manufacturing experience (ISO 13485, FDA QSR)
Cross-functional technical project leadership
Technical documentation (protocols, reports, risk assessments, work instructions)

Qualification:

Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related discipline
10+ years of medical device experience with significant balloon catheter process development exposure
Experience with balloon catheter materials such as PET, Nylon, and Pebax
Background in extrusion, injection molding, precision components, and catheter assembly
Master’s Degree in Engineering (preferred)
Experience with automation in catheter manufacturing (preferred)

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Contact: kswaroop@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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This job at Judge Group is located in Osseo, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Judge Group?

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