Senior Leader, Human Factors for Medical Devices

Merck & Co.; Rahway (NJ); Hybrid; USD 157,000 - 247,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking a Principal Scientist to lead a Human Factors team focused on design, development, and regulatory compliance for combination products and medical devices. You will guide usability studies, risk assessments, and post‑market activities, interfacing with product, regulatory, and quality teams.

The role requires 10+ years in Human Factors with strong leadership, communication, and problem‑solving skills in a regulated environment.

Qualifications

• BA/BS in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management with 10+ years of related experience.
• Strong knowledge of human factors, device regulatory requirements, and industry standards.

Responsibilities

• Lead and manage a Human Factors team across the product lifecycle, including risk assessment, usability testing, and regulatory submission materials.
• Coach and mentor junior scientists to foster growth within the organization.
• Collaborate with cross‑functional teams to ensure regulatory compliance and user‑centered design across concept through post‑market.

Skills

Adaptability

Combination Products

Data Analysis

Finite Element Analysis

Innovative Thinking

Leadership Mentoring

Pharmaceutical Process Development

Professional Collaboration

Professional Networking

Quality by Design

Regulatory Filings

Strategic Thinking

Technology Transfer

Education

BS in Human Factors

Job description

Merck & Co. in Rahway, NJ, is seeking a Principal Scientist to lead a Human Factors team focused on design, development, and regulatory compliance for combination products and medical devices. You will guide usability studies, risk assessments, and post‑market activities, interfacing with product, regulatory, and quality teams.

The role requires 10+ years in Human Factors with strong leadership, communication, and problem‑solving skills in a regulated environment.