Requirements & Risk Management * Solid understanding of systems engineering principles (requirements management, architecture, verification & validation, risk management) * Familiarity with systems engineering tools for requirements, modeling, or risk management is a plus * Develop and manage system-level requirements, workflows, use cases, and specifications * Support risk management activities in compliance with medical device regulations (e.g., ISO 14971) * Work closely with Human Factors Engineering, Systems Integration, Software, Hardware, Verification & Validation, Quality, Product Management, and Operations
mehr