Director, Human Factors Engineering

About the role

The Human Factors Engineering (HFE) Lead is part of the R&D organization supporting Vantive, setting the direction for Human Factors as a critical discipline shaping safe, effective, user-centered therapy systems across the product lifecycle. The role positions Human Factors as a cross-disciplinary capability spanning human factors science, clinical context, product strategy, and engineering.

Responsibilities

• Serve as a core voice in product and engineering decision forums, shaping system-level design, usability, and risk tradeoffs
• Provide enterprise-level leadership for Human Factors Engineering, usability, UI, and UX across global R&D programs, ensuring the function is positioned as a strategic discipline that complements and strengthens engineering, clinical, and product management decision-making
• Build organizational capability through coaching, mentoring, succession planning, and development of functional leaders and technical experts
• Earn influence at the most demanding engineering and product management decision forums by bringing strong judgment, technical depth, and a compelling Human Factors perspective to complex tradeoff discussions
• Define and drive the long-range strategy, operating model, governance, and capability roadmap aligned with R&D and business priorities
• Drive execution and decision-making across complex, global, and matrixed environments while balancing safety, compliance, technical risk, and program timelines
• Enable scalable HFE engagement models that support both platform and product team operating models, increasing functional integration and enabling faster iteration across programs
• Champion a vision for Human Factors that elevates the company’s home dialysis strategy, bringing deep understanding of home patient care, passion for user-centered innovation, and the ability to guide teams beyond execution toward differentiated patient and clinician experiences
• Lead the global Human Factors Engineering function, including organizational design, resource strategy, talent development, and delivery support across medical device programs
• Ensure Human Factors, principles are consistently applied to the design, development, and evaluation of therapy systems
• Own functional strategy, portfolio prioritization, resource planning, and execution for user research, interface definition, formative and summative usability evaluations, use-related risk analysis, and validation
• Ensure generation, review, and approval of human factors, UI, UX, and usability engineering deliverables in compliance with applicable FDA, ISO, and IEC standards
• Support selection and oversight of third-party vendors for user research, interface development, and formative and summative usability evaluations and testing
• Drive integration of Human-AI interaction considerations and end-to-end therapy journey design across patient and clinician workflows
• Ensure alignment of HFE scope, plans, and deliverables with program milestones, incorporating real-world usage data and post-market insights into continuous improvement
• Ensure a balanced approach across digital, device, and therapy system design, grounded in patient and clinician workflows
• Cross-functional & Program Engagement: Serve as a strategic partner to program teams, functional leaders, and executive stakeholders on human factors, usability, UI, UX, and product interaction topics
• Ensure alignment on scope, risks, timelines, and deliverables, and support effective cross-functional decision-making
• Support product quality, support regulatory outcomes, and improve the patient and clinician experience
• Partner closely with the global R&D team in India to ensure Human Factors is fully integrated into program execution, capability building, and day-to-day decision-making

Qualifications

• Deep knowledge of home patient care and a passion for advancing Human Factors as a differentiating capability in home dialysis and connected care experiences
• Functional management experience leading Human Factors Engineering activities and teams in a regulated environment
• Proven experience in HFE principles and methodologies, including ergonomics, usability evaluations, data collection, and data analysis
• Proven experience applying human factors techniques across the product lifecycle, including user research, prototyping, formative and summative evaluations, and use-related risk analysis
• Demonstrated working knowledge of IEC 60601-1-6, IEC 62366, and FDA Human Factors / Usability Guidance, with experience working in a regulated industry
• Ability to synthesize inputs from Marketing, Quality, Regulatory, and Engineering
• Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope
• Ability to decompose complex problems into actionable task lists and drive execution through cross-functional teams
• Deep understanding of design requirements for development and validation

Education & Experience

• BS or MS in Human Factors Engineering, Engineering, UI/UX, or a related discipline
• Candidates with cross-education or equivalent depth of experience across Human Factors, clinical, product, and engineering domains are strongly preferred
• 12+ years of relevant experience leading Human Factors, UX, product development, or engineering in medical devices or other regulated products, including responsibility for shaping user-centered product strategy and execution
• 10+ years of progressive people leadership experience, including leading managers and building high-performing global teams
• Demonstrated experience working with regulatory and certification agencies