Position SummaryWe are seeking a highly motivated, hands-on
Senior Medical Device R&D Engineer to support the design, development, prototyping, testing, and manufacturing transfer of interventional catheter devices. This is a highly visible
Individual Contributor (IC) role requiring both technical leadership and strong execution skills. The ideal candidate is a "do-er" who enjoys hands-on engineering work, thrives in a startup environment, and can independently drive projects while collaborating across multidisciplinary teams.
Roles and Responsibilities- Lead technical projects related to the design, development, testing, and manufacturing transfer of interventional catheter devices
- Provide technical leadership while remaining highly hands-on in day-to-day engineering activities
- Support development activities for both new and existing products, including sustaining engineering efforts
- Perform hands-on prototyping, troubleshooting, and testing of medical devices
- Generate technical documentation in accordance with Design Control requirements
- Develop test methods, protocols, and reports for:
- concept evaluations
- verification & validation testing
- sustaining engineering product iterations
- component qualification
- packaging and shelf-life validation
- Oversee and support R&D technician activities including testing and prototype assembly
- Generate and maintain:
- Bills of Materials (BOMs)
- manufacturing process instructions
- engineering specifications
- risk management documentation
- Work directly with suppliers to support component development and resolve non-conformance issues
- Collaborate cross-functionally with manufacturing, quality, regulatory, and leadership teams
- Help maintain shared lab and prototype spaces
Minimum Qualifications- Bachelor's degree in Mechanical Engineering
- Minimum 10 years of medical device R&D experience
- Strong working knowledge of ISO 13485 regulated Design Controls
- Experience adhering to document control systems and completing engineering change documentation
- Hands-on catheter prototyping and testing experience required
- Strong hands-on engineering mindset with ability to independently prototype, build, troubleshoot, and iterate device concepts
- Startup and/or small-company experience preferred
- Proven ability to operate effectively as a technical Individual Contributor in a fast-paced environment
- SolidWorks proficiency including:
- 3D component and assembly modeling
- 2D drawings per ASME Y14.5
- Knowledge of catheter manufacturing materials and processes including:
- braiding
- lamination
- laser welding
- adhesive bonding
- packaging
- Strong technical writing and documentation skills required
- Excellent verbal and written communication skills
- Ability to explain technical concepts across multidisciplinary teams
- Ability to manage multiple priorities in a rapidly changing organization
- High level of maturity, accountability, and self-motivation
Preferred Qualifications- Catheter design and development experience strongly preferred
- Experience supporting FDA and/or Notified Body regulatory submissions
- Experience using cloud-based document control systems
- Demonstrated technical project leadership experience preferred
Additional Information- This is a fully onsite role based in San Jose, CA
- No relocation or immigration sponsorship available
- Principals only please
