Senior Scientist, Drug/Device Combo Products (Hybrid)

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 (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR). 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. Required Skills Analytical Method Development Creativity Data Compliance Geometric Dimensioning And Tolerancing (GD&T) ISO 13485 Medical Devices Manufacturing Processes Mechanical Design Mechanical Testing Pharmacology Pharmacovigilance Policy Compliance Procedure Adherence Product Development Product Launch Planning 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. 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. 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 #J-18808-Ljbffr Merck