Senior Software Design Assurance (Sr Software Design Quality) Engineer
Core
Ensuring software design conformance to safety and quality regulations for cloud-based, data platform, and AI/ML-enabled medical devices.
Role type
Senior Software Design Assurance Engineer
Builds
Cloud-hosted services, data pipelines, and AI/ML components for continuous glucose monitoring systems
Domain
Medical device software / Cloud infrastructure / AI/ML
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software design assurance (IEC 62304, 21 CFR 820, ISO 13485), Software Hazard Analysis (SHA), design FMEA, requirements traceability, software configuration management, tool validation, risk management, change control assessment, regulatory compliance review
Preferred skills
AI/ML experience, ASQ CSQE certification
Technologies
Cloud services, data pipelines, API, service-oriented systems
Responsibilities
Provide technical guidance on software development processes and regulations; lead application of software development and validation practices; drive pre-market risk management deliverables; review and approve software design control deliverables; support post-market activities and CAPA; author and maintain technical documentation; assess change control activities
Seniority
Senior, hands-on IC
