Senior Scientist, Drug/Device Combo Products (Hybrid)
Merck
September 03, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Senior Scientist, Human Factors
Responsibilities
- Lead and manage human factors activities across the full product design/development lifecycle in a regulated environment (human factors plan; identify customer needs/intended use/hazards; provide HF inputs for product/packaging; task/use error analysis; instructions for use; formative/summative studies; regulatory submission materials; post-market surveillance; training needs).
- Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF, manage risk, and ensure regulatory compliance.
- Maintain records/databases supporting regulatory compliance; support internal HFE process consistency/efficiency.
- Lead regulatory deliverables: HF protocols/reports; linkage to ISO 14971 risk management; hazard/use-related risk analyses; FDA and EU MDR submission materials.
- Conduct independent scientific literature reviews and database research; synthesize findings.
Qualifications
- B.A./B.S in Human Factors, Ergonomics, Cognitive/Experimental Psychology, or Sociology + 3 years related experience; or M.A./M.S. in one of the above.
- Strong knowledge of human factors, device regulatory requirements, and industry standards for device systems.
- Preferred: team/people coaching experience.
- Excellent communication, leadership, problem-solving; ability to manage multiple priorities in a fast-paced environment.
Required skills
- Analytical Method Development; Data Compliance; Policy Compliance; Procedure Adherence; Product Development; Product Launch Planning; ISO 13485; Manufacturing Processes; Mechanical Design/Testing; Geometric Dimensioning & Tolerancing (GD&T); plus Pharmacology/Pharmacovigilance; Creativity.
Benefits (if applicable)
- Medical, dental, vision; retirement (401(k)); paid holidays, vacation, compassionate and sick days.
Application instructions
- 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 product design/development lifecycle in a regulated environment (human factors plan; identify customer needs/intended use/hazards; provide HF inputs for product/packaging; task/use error analysis; instructions for use; formative/summative studies; regulatory submission materials; post-market surveillance; training needs).
- Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF, manage risk, and ensure regulatory compliance.
- Maintain records/databases supporting regulatory compliance; support internal HFE process consistency/efficiency.
- Lead regulatory deliverables: HF protocols/reports; linkage to ISO 14971 risk management; hazard/use-related risk analyses; FDA and EU MDR submission materials.
- Conduct independent scientific literature reviews and database research; synthesize findings.
Qualifications
- B.A./B.S in Human Factors, Ergonomics, Cognitive/Experimental Psychology, or Sociology + 3 years related experience; or M.A./M.S. in one of the above.
- Strong knowledge of human factors, device regulatory requirements, and industry standards for device systems.
- Preferred: team/people coaching experience.
- Excellent communication, leadership, problem-solving; ability to manage multiple priorities in a fast-paced environment.
Required skills
- Analytical Method Development; Data Compliance; Policy Compliance; Procedure Adherence; Product Development; Product Launch Planning; ISO 13485; Manufacturing Processes; Mechanical Design/Testing; Geometric Dimensioning & Tolerancing (GD&T); plus Pharmacology/Pharmacovigilance; Creativity.
Benefits (if applicable)
- Medical, dental, vision; retirement (401(k)); paid holidays, vacation, compassionate and sick days.
Application instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.