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 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 required.
• 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