design-history-file jobs in San Diego

This Systems Engineer role at a medical device company requires decomposing regulatory and stakeholder requirements into testable system specifications, leading design reviews and verification/validation activities, and supporting risk management under FDA and ISO frameworks. The position demands 2+ years in a regulated medical device environment, with responsibility for traceability documentation, design history files, failure investigation, and CAPA activities.…See more Key competencies include FDA design controls, ISO 14971 risk management, human factors/usability per FDA guidance, and cross-functional communication of complex system interfaces to diverse audiences.

Lead the Sensor Technology workstream for Dexcom's Innovation, Ventures & Sensor Technology PMO, managing biosensing technology development from concept through product lifecycle. Own integrated program timelines, Work Breakdown Structure, and design controls compliance under 21 CFR 820 regulations.…See more Manage budget, resources, risk, documentation in the PLM system, and coordinate build/test activities while serving as the primary stakeholder liaison. This role requires significant medical device development expertise, strong project management skills across waterfall and hybrid methodologies, and preferably a technical background in Material Science or Electrochemistry.