Staff Mechanical Engineer

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 RoleYou’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 DoIntegrate mechanisms, electronics, motion, fluidics, and packaging into a cohesive, user-centered productTranslate user needs into design requirements, partnering with industrial designLead risk analysis to drive design decisions and mitigations from the earliest stagesOwn electronics integration within the mechanical system alongside electrical engineeringDesign molded and machined assemblies using tolerance analysis as a core design toolPartner with regulatory, quality, and manufacturing on design controls, V&V, biocompatibility, sterilization, human factors, and design transferCoordinate projects, timelines, and budgets; mentor junior engineers as the team growsWhat You BringBS in Mechanical Engineering or related field (MS a plus)8+ years of mechanical product design experience, including medical devices or other safety-critical systemsTrack record taking a product from design through verification into volume manufacturingExperience as the technical integrator across mechanical, electrical, industrial design, and user requirementsExperience designing mechanisms and moving assemblies, ideally compact motorized electromechanical devicesDeep 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