Sr. Product Development Engineer
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 Sr. 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
Desired 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 preferred
- Demonstrated experience bringing products from concept to market
- Working knowledge of FDA QSR and ISO 13485 regulations
- Proficiency in SolidWorks
- Strong statistical understanding
- Excellent communication skills and customer-facing experience
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