Senior Human Factors Engineer - Usability

• Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure Amgen products are safe and effective for end users
• Lead and support human factors and usability engineering activities to improve the design of products, specifically the device-user interface
• Develop, strategize, and implement a risk-prioritized, fit-for-purpose approach to HF activities
• Ensure human-system capabilities and limitations are accurately reflected in the system requirements, and HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements
• Identify, lead, and support appropriate human factors and usability engineering activities to improve the design of device-user interfaces, including the device, packaging, labeling, and instructions for use to minimize the potential for use errors
• Analyze objective and subjective data from usability studies to inform product design, identify and mitigate use-risk, and provide robust solutions
• Lead the design and execution of human factors formative and summative activities, including moderation, note taking, vendor engagement, and analysis of data
• Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards
• Create documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports, and regulatory submissions
• Clearly and actively communicate regularly with key internal and external partners

Doctorate OR Master’s degree and 2 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR Bachelor’s degree and 4 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR Associate’s degree and 8 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR High school diploma / GED and 10 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field

• Bachelor’s or Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 5-10 years of industry experience, working in multi-functional, fast-paced corporate environments
• HF experience in the design and manufacturing of injectable devices (e.g., auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive/minimally invasive drug delivery systems (e.g., pulmonary, transdermal)
• HFE/UE experience planning, coordinating, conducting, analyzing, reporting human factors studies without vendor support
• Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies
• Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs
• Experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
• Experience working in development organizations, particularly virtual development environments
• Experience working within the development of systems design, verification, and validation
• Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible