design-fmea jobs in San Diego

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.…See more 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.

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.