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Product Development Engineer
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2026-09-13
Listing for:
SkyWater Search Partners
Full Time
position Listed on 2026-09-13
Job specializations:
-
Engineering
Product Engineer, Biomedical Engineer
Job Description & How to Apply Below
We are partnering with a rapidly growing, vertically integrated medical device contract manufacturer specializing in advanced catheter technologies. This team is known for technical depth, speed, and a high-accountability culture. If you thrive in a fast-paced, client-facing environment and want real ownership over your programs, this is a compelling next step.
The Product Development Engineer serves as a technical lead on catheter development programs, driving projects from concept and feasibility through validation and market release. This individual will collaborate cross-functionally while interfacing directly with customers to ensure quality, timeline, and performance expectations are met.
Responsibilities:- Lead product development efforts from concept through commercialization
- Design and develop catheter systems including reinforced shafts, delivery systems, and steerable technologies
- Conduct feasibility studies, risk analysis, and validation activities (IQ/OQ/PQ)
- Generate and maintain detailed design documentation per FDA QSR and ISO 13485
- Prepare project plans and manage timelines, resources, and deliverables
- Interface directly with clients to answer technical questions and provide updates
- Coordinate with suppliers and internal manufacturing teams
Skills And Experience:
- Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent experience)
- 3-10 years of medical device product development experience. Catheter Design experience required.
- Demonstrated experience bringing products from concept to market
- Working knowledge of FDA QSR and ISO 13485 regulations
- Proficiency in Solid Works
- Excellent communication skills and customer-facing experience
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