Process Development Engineer I-II

Location:

Osseo, MN Description:

Job Title:

Senior / Principal Process Development Engineer -

Balloon Catheter Location:

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) By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!