The Software Design QA Engineer 2 provides technical oversight and guidance to software development teams to ensure compliance with medical device regulations (IEC 62304, 21 CFR 820, ISO 13485, ISO 14971) and quality standards. Responsibilities include leading design assurance activities, reviewing and approving design control deliverables, managing pre-market risk assessments (SHA, design FMEA, cybersecurity risk management), supporting configuration management and tool validations, and driving post-market activities including anomaly assessment and CAPA.… The role requires deep knowledge of FDA and international medical device regulations, SDLC processes, and software development methodologies (Agile, Waterfall), with cross-functional collaboration across engineering, test, regulatory, and project management teams.
21-cfr-820 jobs in San Diego
This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.… The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.
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.… 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.… 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.