Pleasanton, CA30+ days ago
Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation, design reviews, tagging/tracing, non-product tools validation, test method validation, and design transfer are in compliance with Calyxo Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations. Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.