Director, Human Factors Engineering

Vantive US Healthcare USA•Deerfield, MN

About The Position

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. The role leads the global HFE function, including strategy, governance, and capability building across user research, HF risk analysis, usability, UX design, and HF validation. Operating in a global matrixed environment, the HFE Lead partners across functions to influence product and system-level decisions.

Requirements

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.
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.

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.
Establish credibility and 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.
Provide oversight and direction for complex or high-risk human factors challenges.
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.
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.
Strengthen 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

Benefits

medical, dental and vision coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
the Employee Discount Program
the Employee Assistance Program (EAP)
childcare benefits