Senior Research And Development Engineer
Listed on 2026-08-11
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Engineering
Product Engineer, Biomedical Engineer, Medical Device Industry
Our client is seeking a Senior R&D Engineer to support the design and development of next-generation catheter-based medical devices. This individual will play a key role in driving product development from concept through design transfer, combining hands-on engineering with the technical rigor required to support product documentation, design controls, and cross-functional development activities.
This is a highly visible role for an experienced medical device engineer who has developed catheter-based products within a structured product development environment but still enjoys working in the lab. The ideal candidate is equally comfortable building and testing prototypes, creating high-quality engineering documentation, and leading technical efforts across multiple projects. They are looking for someone who brings the discipline and best practices of a larger medical device organization while maintaining the adaptability and urgency of a startup environment.
Day-to-Day- Lead the design and development of catheter-based medical devices from concept through design transfer.
- Build, assemble, and evaluate catheter prototypes while supporting feasibility and proof-of-concept activities.
- Develop fixtures, tooling, and sub-assemblies to support product development and engineering testing.
- Perform bench testing, analyze engineering data, and drive iterative design improvements.
- Create high-quality engineering documentation including drawings, specifications, design history documentation, engineering reports, protocols, and technical documentation.
- Support design controls, risk management activities, verification planning, and design transfer.
- Collaborate closely with Manufacturing, Process Development, Quality, Regulatory, and Program Management throughout the product development lifecycle.
- Mentor junior engineers and provide technical guidance during development activities.
- Balance hands-on laboratory work with technical documentation and cross-functional project leadership.
- Bachelor's degree in Engineering or a related technical discipline.
- 7-15+ years of Medical Device R&D or Product Development experience.
- Experience with catheter manufacturing processes including extrusion, thermal bonding, reflow, braiding, coil reinforcement, or catheter assembly.
- Strong background working within structured medical device product development environments.
- Extensive experience creating engineering drawings, design documentation, specifications, protocols, and technical reports.
- Strong understanding of medical device design controls and product development processes.
- Experience performing prototype development, bench testing, troubleshooting, and design iteration.
- Excellent technical writing, communication, and cross-functional collaboration skills.
- Experience supporting new product introductions (NPI).
- Experience with DFMEA, pFMEA, and risk management.
- Experience mentoring junior engineers.
- Startup or fast-paced product development experience.
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