Associate Principal Scientist, Human Factors

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 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‑mortem surveillance. Key Responsibilities and Activities Establish and 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. Improve System‑Level Procedures (Methods, Governance, Capability), including, but not limited to Define and continuously improve HF process, standards, and templates per IEC 62366‑1 and FDA guidance. 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, or Chemistry 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 coaching. Excellent communication, leadership, and problem‑solving skills. Ability to work in a dynamic and fast‑paced environment, managing multiple priorities effectively. Required Skills Combination Products Commercialization Design Controls Human Factor Engineering Human Factors Labels Medical Devices Regulatory Requirements Risk Assessments Risk Management Test Method Validation Troubleshooting Usability Testing User Research 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. Please click here if you need an accommodation during the application or hiring process. Equal Employment Opportunity Statement 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. Salary Range $142,400.00 - $224,100.00 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. Bonus and Incentives The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits 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 Application You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 05/30/2026 Requisition ID

R399946