Principal Scientist, Human Factors

Role: Lead Human Factors scientist overseeing a team responsible for human performance and usability activities in the development and lifecycle management of combination products and medical devices. Objectives include ensuring regulatory compliance, risk mitigation, and user-centered design across product stages. Responsibilities encompass managing human factors activities such as task analysis, use error analysis, usability testing, hazard assessment, and regulatory documentation; mentoring junior staff; strategic planning for innovative designs; and collaborating with cross-functional teams (e.g., regulatory, clinical, manufacturing). Qualifications: B.A./B.S. in Human Factors, Psychology, Engineering, or related fields; 10+ years of relevant experience; strong knowledge of human factors, device regulations, and industry standards; leadership skills preferred. High-Value: Experience in combination product development, US and global regulatory compliance, GxP environments, risk assessment, usability testing, and post-market surveillance. Work setup: hybrid in the US, with 25% travel; working with diverse internal teams and external regulatory bodies.