Staff Quality Engineer

Staff Design Quality Engineer – Class III Implantable Medical DeviceSan Francisco Bay Area | Full-Time | HybridA fast-growing medical device company developing next generation implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform.This is a highly technical, hands-on role embedded directly with R&D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages.You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment.ResponsibilitiesPartner closely with R&D and systems engineering teams to integrate design quality into product developmentLead and support design control activities throughout the product lifecycleDrive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategiesSupport verification and validation planning and executionEnsure compliance with FDA design control requirements and global quality standardsParticipate in cross-functional design reviews and technical decision makingHelp translate regulatory and quality requirements into practical engineering processesQualificationsBS or MS in Engineering (Biomedical, Mechanical, Electrical, or related)7+ years of experience in medical device product development or design qualityStrong experience with design controls and risk managementExperience supporting Class II or Class III medical devicesAbility to collaborate closely with R&D in early-stage product developmentExperience supporting IDE, PMA, or complex regulatory pathways is highly valuedWhat Makes This Opportunity UniqueWork on cutting-edge implantable technologyJoin a highly technical engineering-driven teamBe involved early in the development lifecycleSignificant opportunity for technical ownership and influenceCompetitive compensation, bonus, and equity packageIf you are interested in learning more, feel free to reach out directly.