Staff/Principal Mechanical Engineer – Medical Device Startup | San Diego, CA (Onsite)
I’m partnering with a venture-backed medical device startup in San Diego developing a wearable automated insulin delivery system that makes life with diabetes simpler and safer. Their product has reached clinical studies, and they’re now hiring a Staff/Principal Mechanical Engineer to carry the hardware system through verification and into volume manufacturing.
The Role
You’ll be the hub of the hardware design: the system integrator who brings together user needs, risk analysis, mechanics, electronics, and industrial design into one cohesive product, while staying hands-on in detailed design, analysis, and debugging.
What You’ll Do
- Integrate mechanisms, electronics, motion, fluidics, and packaging into a cohesive, user-centered product
- Translate user needs into design requirements, partnering with industrial design
- Lead risk analysis to drive design decisions and mitigations from the earliest stages
- Own electronics integration within the mechanical system alongside electrical engineering
- Design molded and machined assemblies using tolerance analysis as a core design tool
- Partner with regulatory, quality, and manufacturing on design controls, V&V, biocompatibility, sterilization, human factors, and design transfer
- Coordinate projects, timelines, and budgets; mentor junior engineers as the team grows
What You Bring
- BS in Mechanical Engineering or related field (MS a plus)
- 8+ years of mechanical product design experience, including medical devices or other safety-critical systems
- Track record taking a product from design through verification into volume manufacturing
- Experience as the technical integrator across mechanical, electrical, industrial design, and user requirements
- Experience designing mechanisms and moving assemblies, ideally compact motorized electromechanical devices
- Deep hands-on expertise with molded and machined parts and advanced tolerance analysis
- Working knowledge of design controls, V&V, risk analysis, biocompatibility, sterilization, and human factors
Staff Mechanical Engineer in San Diego at BioTalent
This position is listed as full time and onsite. It was posted 2 days ago.