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Process Development Engineer I-II

Judge Group

  • Osseo, MN
  • 30+ days ago

    Highlights

    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. 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.

    Numbers & Facts

    LocationOsseo, MN
    IndustryComputer/IT Services
    Company Size5,000 to 9,999 employees
    Year Founded1970
    Websitehttps://www.judge.com

    Description

    Location: Osseo, MN
    Description:
    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)

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

    About Company

    The Judge Group Inc., is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better. Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India.

    The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications. If you would like to learn more about The Judge Group visit www.judge.com or call toll free (800) 360-4474.

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