Staff Product Development Engineer
Location
Austin, Texas Metropolitan Area
Level
Staff / Principal
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-09-10
Responsibilities
- Serve as a senior mechanical engineering contributor and provide SolidWorks technical mentorship for junior engineers.
- Lead refinement of the Connexus system through design maturity, formal verification/validation (V&V), and into Pivotal and commercial launch.
- Consult with and review designs from the advanced R&D team, guiding them to consider regulatory and quality constraints early in the design process.
- Establish, implement, and embed medical device best practices across the engineering team.
- Ensure all designs, documentation, and processes align with FDA, ISO, and industry standards.
Job Requirements
- Bachelor’s or Master’s degree in Mechanical Engineering or related technical discipline.
- Minimum 8 years of medical device development experience, preferably in the active implantables space.
- Proven experience refining medical devices through V&V and clinical readiness, including DFM, FMEA, TM development, TMV, IQ/OQ/PQ/PPQ.
- Strong foundation in medical device best practices, including design controls, ISO 13485, ISO 14971, and DHF management.
- Advanced SolidWorks expertise (CAD, assemblies, GD&T).
- Hands-on experience with troubleshooting and maturing early-stage medical device designs.
- Demonstrated ability to mentor junior engineers and embed best practices across team workflows.
