Software Design Assurance Quality Engineer
Core
Embed quality, risk management, and design controls throughout the development of AI-enabled healthcare software to ensure patient safety.
Role type
Quality Engineer (Software Design Assurance)
Builds
AI-enabled cardiac monitoring products, data algorithms, and AI cloud-platform activities
Domain
Healthcare / Medical Devices / AI
Deliverable
production ML models | product features
Required skills
Software engineering fundamentals, regulated software development knowledge, risk management, design control processes, requirements review, test procedure evaluation, technical evidence assessment, AI technical understanding
Preferred skills
French language proficiency
Technologies
None explicitly stated
Responsibilities
Partner with engineering teams to review requirements and drive risk management from early design stages; Review design documentation, test procedures, performance evidence, complaints, and non-conformances to identify gaps and assess patient risk; Drive corrective actions in collaboration with engineering, regulatory, and medical safety teams; Build expertise across regulated software, patient safety, and AI-related risk.
Seniority
Mid-level, hands-on IC
