Senior Software Design Assurance Engineer
Core
Ensures software quality and regulatory compliance for medical device products through verification, validation, and risk management.
Role type
Senior Software Design Assurance Engineer
Builds
Medical device software products compliant with FDA regulations
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software quality engineering, FDA regulations knowledge, Risk assessment (FMEA), Test case protocol review, Design plan review, Cross-functional collaboration, Training development, Audit support
Preferred skills
Advanced degree, Enterprise business unit experience, Quality tools/methodologies expertise
Technologies
None explicitly stated
Responsibilities
Provide quality oversight for software verification and validation activities, Lead risk evaluation and management activities for software development, Review and approve software test case protocols and reports, Participate in technical reviews to ensure design plans are met, Develop and conduct training for software development programs, Support audits and lead quality system improvement activities
Seniority
Senior, hands-on IC with potential oversight of team members