Software Design QA Engineer 2

Summary

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.