Senior Scientist, Drug​/Device Combo Products

• Lead and manage human factors activities for combination products and medical devices through design, development, commercialization, lifecycle management, and post-market surveillance
• Create human factors plans
• Work with other disciplines to identify customer needs, intended use, potential hazards, and harms
• Provide product and packaging design inputs and requirements
• Perform task and use-error analyses
• Design instructions for use
• Conduct formative and summative studies
• Prepare regulatory submission materials
• Address post-market surveillance and training needs
• Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling teams
• Manage and maintain records and databases supporting regulatory compliance
• Support and maintain internal human factors engineering processes
• Lead regulatory deliverables, including human factors protocols/reports, risk-management linkage, hazard/use-related risk analyses, and FDA/EU MDR submission materials
• Perform scientific literature reviews and database research, independently synthesizing information for human factors research
• Perform other job-related duties or special projects as required

• B.A./B.S. in Human Factors, Ergonomics, Cognitive or Experimental Psychology, or Sociology plus three years of related experience, or M.A./M.S. in one of these disciplines
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems
• Experience with combination products and medical devices
• Knowledge of US and global regulatory policies/guidance
• Knowledge of ISO 14971 and EU MDR submission requirements
• Excellent communication, leadership, and problem-solving skills
• Ability to work in a dynamic, fast-paced environment and manage multiple priorities effectively
• Current employees apply through the Workday Jobs Hub
• US and Puerto Rico residents only
• No visa sponsorship

Demonstrates expertise in human factors engineering for medical devices, including regulatory compliance, risk management, and user-centered design. Proficient in conducting formative and summative studies, preparing regulatory submissions, and collaborating across multidisciplinary teams.

• Human Factors Engineering
• Regulatory Compliance
• Combination Products
• ISO 14971 Knowledge
• FDA/EU MDR Submission

• Human Factors Plans
• Task and Use-Error Analyses
• Formative Studies
• Summative Studies
• Regulatory Submission Materials
• Risk-Management Linkage
• Hazard/Use-Related Risk Analyses
• Scientific Literature Reviews
• Database Research
• Product and Packaging Design Inputs

• Excellent Communication
• Leadership Skills
• Problem-Solving Skills
• Ability to Manage Multiple Priorities
• Adaptability in Fast-Paced Environments

• Medical Devices
• Device Regulatory Requirements
• US Regulatory Policies
• Global Regulatory Guidance
• Post-Market Surveillance
• Human Factors Research
• Cognitive Psychology
• Experimental Psychology
• Sociology
• Ergonomics