Senior Scientist, Drug/Device Combo Products (Hybrid)

Job Description Senior Scientist, Human Factors 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 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. The Senior Scientist in this role will be responsible for performing and managing human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products. Key Responsibilities and Activities: 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 plan, working with other disciplines to identify customer needs, intended use and potential hazard/harm, providing product and packaging design inputs/requirements, performing task and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need. Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF, manage risk and ensure regulatory compliance. In collaboration with cross-functional colleagues, ensure the management and maintenance of records and databases that support regulatory compliance. Collaborate cross‑ functionally to support and maintain the internal HFE processes to ensure consistency, efficiency and compliance. Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO14971), hazard/use‑related risk analyses, and submission materials (FDA, EUMDR). Perform scientific literature reviews and database research on various topics independently and synthesize relevant information in support of the human factors research. Perform other job related duties or special projects as required. Qualifications: B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology plus three years of related experience or M.A/M.S. in one of the above disciplines. 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. # eligibleforERP #PRD Required Skills: Analytical Method Development Creativity Data Compliance Geometric Dimensioning And Tolerancing (GD&T) ISO13485 Medical Devices Manufacturing Processes Mechanical Design Mechanical Testing Pharmacology Pharmacovigilance Policy Compliance Procedure Adherence Product Development Product Launch Planning Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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 $117,000.00 - $184,200.00 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 compassionate and sick days More information about benefits is available at 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: No relocation 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: 09/9/2026 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr MSD Malaysia