Senior Scientist, Drug/Device Combo Products (Hybrid)
Merck
September 03, 2026
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Senior Scientist, Human Factors
Responsibilities:
- Lead and manage human factors activities across the full regulated product design/development lifecycle (human factors plan; customer needs; intended use; hazard/harm identification; product/packaging design inputs; task and use error analysis; instructions for use; formative/summative studies; regulatory submission materials; post-market surveillance and training needs).
- Partner cross-functionally (marketing, program management, clinical, safety, regulatory, manufacturing, packaging/labeling) to integrate HF, manage risk, and ensure regulatory compliance.
- Maintain regulatory compliance records/databases; support internal HFE process consistency, efficiency, and compliance.
- Lead regulatory deliverables: HF protocols/reports; linkage to ISO 14971 risk management; hazard/use-related risk analyses; submission materials (FDA, EU MDR).
- Perform scientific literature reviews and database research; synthesize findings to support HF research.
Qualifications:
- B.A./B.S. in Human Factors, Ergonomics, Cognitive/Experimental Psychology, Sociology + 3 years related experience, or M.A./M.S. in a related discipline.
- Strong knowledge of human factors and device regulatory requirements/industry standards.
- Prefer experience coaching/mentoring.
- Excellent communication, leadership, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
Required skills: Analytical Method Development; Creativity; Data Compliance; ISO 13485; Policy Compliance/Procedure Adherence; Product Development; Product Launch Planning; (also listed technical areas such as GD&T, manufacturing processes, mechanical design/testing; pharmacology/pharmacovigilance).
Compensation/Benefits (if applicable): $117,000.00–$184,200.00 salary range; annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, 401(k), paid holidays/vacation.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
Responsibilities:
- Lead and manage human factors activities across the full regulated product design/development lifecycle (human factors plan; customer needs; intended use; hazard/harm identification; product/packaging design inputs; task and use error analysis; instructions for use; formative/summative studies; regulatory submission materials; post-market surveillance and training needs).
- Partner cross-functionally (marketing, program management, clinical, safety, regulatory, manufacturing, packaging/labeling) to integrate HF, manage risk, and ensure regulatory compliance.
- Maintain regulatory compliance records/databases; support internal HFE process consistency, efficiency, and compliance.
- Lead regulatory deliverables: HF protocols/reports; linkage to ISO 14971 risk management; hazard/use-related risk analyses; submission materials (FDA, EU MDR).
- Perform scientific literature reviews and database research; synthesize findings to support HF research.
Qualifications:
- B.A./B.S. in Human Factors, Ergonomics, Cognitive/Experimental Psychology, Sociology + 3 years related experience, or M.A./M.S. in a related discipline.
- Strong knowledge of human factors and device regulatory requirements/industry standards.
- Prefer experience coaching/mentoring.
- Excellent communication, leadership, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
Required skills: Analytical Method Development; Creativity; Data Compliance; ISO 13485; Policy Compliance/Procedure Adherence; Product Development; Product Launch Planning; (also listed technical areas such as GD&T, manufacturing processes, mechanical design/testing; pharmacology/pharmacovigilance).
Compensation/Benefits (if applicable): $117,000.00–$184,200.00 salary range; annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, 401(k), paid holidays/vacation.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.