Hybrid Director, Human Factors

at MSD

• Job title: Director, Human Factors
• Job type: Full Time
• Experience level: Lead
• Salary: $156,900 - $247,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Lead Human Factors activities ensuring compliance for combination products in medical device development. Collaborate with cross-functional teams for product launch and monitoring.

Responsibilities

• Coach and mentor junior scientists, fostering their professional growth and development within the organization.
• Lead Human Factors Project Work (Strategy and Execution), including, but not limited to Own HF strategy from early concept through validation and post-market for devices and combination products.
• Build HF plans and study roadmaps; select methods (user research, task/use-error analysis, risk mitigation, formative/summative usability testing).
• Turn user insights into design inputs for device UI, packaging, labeling, and IFU; guide intuitive, safe designs.
• Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF and manage risk.
• Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR).
• Maintain compliant HF documentation and traceability; ensure audit readiness.
• Monitor post-market use-related issues and drive corrective actions and training.
• Define and continuously improve HF process, standards, and templates per IEC 62366-1 and FDA guidance.
• Set clear governance (gates, criteria, documentation) for consistent HF quality across programs.
• Create reusable methods for needs discovery, user profiling, task analysis, and use-related risk assessment.
• Provide portfolio-level guidance for UI, labeling, and IFU to reduce use-related risk.
• Train cross-functional teams on HF practices and compliant documentation.
• Establish metrics and feedback loops (study quality, defects, post-market signals) to prioritize improvements.
• Maintain centralized HF libraries and tools to enable reuse and speed development.

Requirements

• B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management plus 15 years of related experience.
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
• Prefer to have experience in team and people management.
• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days