Senior Human Factors Engineer

Role: Lead human factors and usability engineering activities for Amgen's drug delivery devices, ensuring safe, effective, and user-friendly interfaces in line with industry standards and regulations. Responsibilities: oversee HFE/UE planning, research, and development; collaborate cross-functionally with engineering, regulatory, quality, clinical, and commercial teams; design and execute formative and summative usability studies; develop risk-based strategies and documentation for design controls, regulatory submissions, and clinical support; support device labeling, packaging, and instruction design; analyze usability data to mitigate use errors. Qualifications: Doctorate or Master's in Human Factors, Psychology, Engineering, or related field, with 2+ years (Master's) or 4+ years (Bachelor's) industry experience in biomedical or medical device HFE; expertise in designing user interfaces for injectable or minimally invasive drug delivery devices; proficiency with diverse HFE methodologies and standards such as IEC 62366, ISO 14971, and FDA guidance. Preferred: 5-7 years of multi-disciplinary industry experience, experience with virtual development, and regulatory submissions. High-Value: focus on devices for biologics or injectables, clinical stage projects, and regulatory compliance. Work Setup: up to 20% travel within the US, role likely hybrid or onsite based on location.