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This is your chance to drive impactful innovation by leading usability studies, guiding risk analysis, and collaborating cross-functionally across R&D, Regulatory, and Marketing teams. Responsibilities: Lead formative and summative usability studies for medical devices. Develop detailed usability and risk analysis reports (IEC -, ISO , etc.). Manage human factors deliverables throughout the product lifecycle. Partner with cross-functional teams to ensure safe and effective device design. Stay ahead of evolving FDA guidance and compliance requirements. Requirements: + years in human factors/usability engineering. Strong command of HFE standards and regulatory frameworks ( CFR Part , ANSI HE). Proven leadership in human factors for medical device development. Skilled communicator and collaborator across disciplines.