Principal Scientist, Human Factors

Role Overview

• Lead and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products
• 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 and manage 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
• Establish and maintain a defined governance framework for consistent HF quality across programs
• Create reusable platform 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 to prioritize improvements
• Maintain centralized HF libraries and tools to enable reuse and speed development
• Stay up to date with the latest advancements in human factors within the regulatory and industry landscape

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
• Masters in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management with a minimum of 12 years of related experience
• Ph.D. in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management with a minimum of 10 years of related experience
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems
• Prefer to have experience with coaching and/or mentoring

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