• Lead Human Factors Strategy & Execution: Own the usability engineering roadmap across the product lifecycle, from early discovery to market release. • Anticipate user needs, risks, and system-level implications before issues arise. • Define the vision, strategy, and priorities for human factors activities and communicate them across cross-functional teams. • Usability Engineering & Design Controls: Lead the creation and maintenance of Usability Engineering Files in accordance with IEC 62366 and FDA Human Factors guidance. • Identify user profiles, tasks, critical use scenarios, usability risks, and system requirements. • Translate user needs, UX research insights, clinical workflows, and business needs into actionable HFE requirements. • User Research & Study Leadership: Independently plan, design, and execute formative and summative usability studies (hardware, software, or integrated systems). • Manage external vendors and ensure high-quality execution, documentation, and data integrity. • Analyze behavioral and physiological data to uncover deep insights that drive product decisions. • Cross-Functional Collaboration & Influence: Champion usability, safety, accessibility, and quality across R&D, Engineering, UX, Clinical, Regulatory, and Marketing. • Facilitate workshops with customers, clinical partners, and internal teams to capture system-level insights and drive alignment. • Proactively identify gaps, propose solutions, and push initiatives forward with minimal supervision. • Thought Leadership & Mentorship: Serve as a subject matter expert for Human Factors Engineering within the organization. • Mentor and guide junior team members on methodology, study design, analysis, and professional development. • Present insights and recommendations persuasively to technical and non-technical audiences, including leadership.