Director, Human Factors

Merck • Upper Gwynedd Township, PA

1d • Hybrid

About The Position

The Human Factors team plays a pivotal role in combination product development (both design and process), commercialization, and lifecycle management. This person will lead and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in our Company's portfolio and pipeline, including acquisition products.
This position will interact extensively with all subject-matter experts within the Device Development team as well as with members of numerous internal cross-functional product development teams from concept through product launch and post-market surveillance.

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.
• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

Nice To Haves

• Prefer to have experience in team and people management.

Responsibilities

• Coach and mentor junior scientists, fostering their professional growth and development within the organization.
• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees