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Process Development Engineer I-II

The Judge Group

Osseo, MN

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JOB DETAILS
SKILLS
Automation, Biomedical Engineering, Catheterization, Component Assembly, Cross-Functional, Equipment Specification, Extrusion, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Industrial Engineering, Injection Molding, Leadership, Manufacturing, Manufacturing Automation, Manufacturing Design, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Process Development, Process Engineering, Process Flow, Process Improvement, Process Manufacturing, Process Validation, Product Design, Product Engineering, Prototyping, Quality System Requirements (QSR), Requirements Management, Risk Analysis, Short Messaging Service (SMS), Technical Leadership, Technical Writing, Technical/Engineering Design, United States Department of Energy (DOE), Welding
LOCATION
Osseo, MN
POSTED
2 days ago
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)


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Contact:

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

About the Company

T

The Judge Group

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.

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Computer/IT Services
FOUNDED
1970
WEBSITE
https://www.judge.com

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