21-cfr-820 jobs in San Diego

This Software Design QA Engineer role focuses on ensuring software development conformance to FDA, IEC 62304, and ISO 13485 standards in a medical device company. The engineer will lead design assurance activities including risk management (SHA, design FMEA), design control reviews, configuration management, and post-market compliance support.…See more The role requires expertise in medical device software development lifecycle processes, regulatory frameworks, and cross-functional collaboration with engineering, test, and regulatory teams.

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.