Principal Scientist, Human Factors

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

Job Description

The Human Factors team plays a pivotal role in combination product development (both design and process), commercialization, and lifecycle management. This person will lead several Human Factors scientists to perform and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products 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:

• The Principal Scientist is responsible for managing a Human Factors team that applies knowledge of human performance (perceptual, cognitive, and motor skills) and Human Factors techniques to a wide range of systems’ issues across the product lifecycle, including customer needs identification, early product device concept selection/screening, user profiles, task analysis, user interface design, use error analysis, risk assessment and mitigation, usability testing, hazard analysis, and post‑launch outcomes analysis.
• Coach and mentor junior scientists, fostering their professional growth and development within the organization.
• Perform and manage human factors activities throughout the whole product design and development cycle within the constraints of a regulated environment, including creating human factors plans, working with other disciplines to identify customer needs, intended use, and potential hazard/harm, providing product and packaging design inputs/requirements, performing task analysis and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post‑market surveillance, and training needs.
• Strategic planning of HF assessment for innovative product design.
• Collaborate with cross‑functional colleagues to create innovative and intuitive‑to‑use products and ensure regulatory compliance through risk management. The cross‑functional team includes marketing, product planning/project management, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging, and labeling.
• Responsible for key development deliverable documents, ensuring the management and maintenance of documents, records, and databases that support regulatory compliance (such as human factors study protocol and report, task analysis, and use error analysis documents, etc.).
• 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.
• Support other quality and GMP compliance activities relating to combination products and medical devices.
• Perform other job‑related duties or special projects as required.

Qualifications:

• B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management plus 10 years of related experience.
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
• Prefer to have experience in team and people management.
• Excellent communication, leadership, and problem‑solving skills.
• Ability to work in a dynamic and fast‑paced environment, managing multiple priorities effectively.

Required Skills:

Adaptability, Combination Products, Data Analysis, Finite Element Analysis (FEA), Innovative Thinking, Leadership Mentoring, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Strategic Thinking, Technology Transfer

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$156,900.00 - $247,000.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R413361