Staff Mechanical Engineer

BioTalent; San Diego (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

BioTalent in San Diego is seeking a Staff/Principal Mechanical Engineer for a medical device startup developing a wearable insulin delivery system. You will own the hardware system from design to volume manufacturing, hands-on with proofing and testing.

You’ll coordinate interfaces across mechanical, electrical, and industrial design, lead risk analysis, and ensure design controls, V&V, biocompatibility, sterilization, and human factors are integrated.

Qualifications

• 8+ years of mechanical product design experience, preferably medical devices or safety-critical systems.
• Experience as the technical integrator across mechanical, electrical, industrial design, and user requirements.
• Experience designing mechanisms and moving assemblies, ideally compact motorized electromechanical devices.
• Hands-on expertise with molded and machined parts and advanced tolerance analysis.
• Knowledge of design controls, V&V, risk analysis, biocompatibility, sterilization, and human factors.

Responsibilities

• Integrate mechanisms, electronics, motion, and packaging into a cohesive, user-centered product.
• Lead risk analysis to drive design decisions and mitigations from early stages.
• Own electronics integration within the mechanical system alongside electrical engineering.
• Coordinate projects, timelines, and budgets; mentor junior engineers as the team grows.

Skills

System integration

Mechanical design

Tolerance analysis

Risk analysis

V&V

Biocompatibility

Human factors

Hands-on prototyping

Education

BS in Mechanical Engineering

MS preferred

Job description

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 analysisWorking knowledge of design controls, V&V, risk analysis, biocompatibility, sterilization, and human factors