Director, Human Factors

Job Description The Director, Human Factors plays a pivotal role in combination product development (both design and process), commercialization and lifecycle management. This person leads the Human Factors team 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 Director 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 Director, Human Factors is responsible for expanding and managing a Human Factors team that apply 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. The Human Factors director is expected to guide his/her team to: 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 analysis and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need. 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 managing, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging and labeling. Responsible for key development deliverable documents, ensure 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 document 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. Minimum education 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. Required experience and skills: Minimum of 10 years of relevant experience, strong knowledge of human factors, device regulatory requirements and industry standards related to device systems. Proven 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.

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