Principal Scientist, Human Factors

Job Description

Principal Scientist, Human Factors

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, such as pre-filled syringes, 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.

Key Responsibilities and Activities:

• 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 and manage compliant HF documentation and traceability; ensure audit readiness.

• Monitor post-market use-related issues and drive corrective actions and training.

• Lead Human Factors Project Work (Strategy and Execution), including, but not limited to

• Define and continuously improve HF process, standards, and templates per IEC 62366-1 and FDA guidance.

• Establish and maintain a defined governance framework (stage gates, decision criteria, documentation) 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 (study quality, defects, post-market signals) 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 and have the ability to represent our company in external communities and exert influence.

Qualifications:

• 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 OR

• 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

• Excellent communication, leadership, and problem-solving skills.

• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

Required Skills:

Preferred Skills:

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US and Puerto Rico Residents Only:

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