Research Development Engineer; Process Development
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-03-08
Listing for:
SciPro
Full Time
position Listed on 2026-03-08
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Product Engineer, Process Engineer
Job Description & How to Apply Below
The Staff R&D Engineer (Process Development) develops and improves catheter manufacturing processes from early prototypes through full production. This role leads process development, testing, and validation while working closely with R&D, Operations, Quality, and Regulatory teams to successfully launch new medical devices.
Key Responsibilities- Develop catheter products and manufacturing processes
- Build and test prototypes and proof-of-concept designs
- Develop and validate test methods and manufacturing processes
- Support pilot builds and transition products to production
- Perform testing, analyze results, and recommend improvements
- Create and maintain technical documentation and process drawings
- Support verification and validation testing
- Work with suppliers to source materials and components
- Participate in design reviews and support product commercialization
- Support existing products and continuous improvement efforts
- Ensure compliance with quality systems and FDA regulations
- Support pilot and commercial manufacturing
- Bachelor’s or Master’s degree in Mechanical or Biomedical Engineering
- 6–8+ years of medical device process development experience
- Experience taking products from prototype to production
- Strong knowledge of materials, manufacturing, and DFM principles
- Experience with Solid Works or similar CAD software
- Experience with statistical analysis and DOE
- Strong communication and teamwork skills
Preferred Experience
- Experience with balloon-expandable or self-expanding devices
- Experience with disposable medical devices
- Experience with modeling tools (FEA or CFD)
- Ability to lift up to 25 lbs
- Ability to work in a fast-paced environment
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