Principal 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 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.

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. #EligibleforERP 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 Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our