Engineer- Human Factors Engineer​/Usability Engineer; HF​/UE

Engineer - Human Factors Engineer / Usability Engineer (HF/UE)

Join Amgen’s mission to serve patients. In this vital role you will support HFE/UE planning, research, development and continuous improvement of drug delivery devices in accordance with regulations and guidelines and foster innovation across the company.

• Work collaboratively with HFE/UE, engineering, design, commercial, and product teams to translate user requirements into products, create user interface (UI) requirements, and enhance the overall user experience across Amgen’s portfolio.
• Support usability activities such as study planning, protocol development, study moderation, data collection, participant recruitment, data analysis, and documentation to support project needs.
• Collaborate with the HFE/UE lead to ensure system capabilities and limitations are reflected in requirements and that HFE/UE input informs product design, packaging, labeling, and training requirements.
• Conduct human factors and usability engineering activities to improve the design of products, including device-user interfaces, packaging, labeling, and instructions for use, minimizing potential use errors.
• Analyze objective and subjective data from usability studies to inform design, support risk minimization, and provide alternative design controls/solutions.
• Assist the HFE/UE lead in preparing for clinical studies and regulatory submissions by applying best practices and standards.
• Prepare documentation to support development activities, design controls, and regulatory submissions, including protocols, task analyses, risk assessments, technical assessments, comparative analyses, reports, data verifications, and other required materials.
• Communicate with internal and external key stakeholders, exercising critical thinking and HFE/UE judgment to determine appropriate next steps.
• This position requires up to 20% yearly local and domestic travel.

• Masters degree in Human Factors Engineering, Usability Engineering, or related Psychology or Industrial Design domains OR
• Bachelor’s degree and 2 years of experience in the regulated medical device and/or biotech industry OR
• Associate’s degree and 6 years of experience in the regulated medical device and/or biotech industry OR
• High school diploma / GED and 8 years of experience in the regulated medical device and/or biotech industry

• Master’s degree in Human Factors, HFE/Usability Engineering, or related discipline with 2+ years of industry experience in multi-functional, fast-paced corporate environments.
• Experience with various HF methodologies including 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.
• Direct user engagement experience to gather, synthesize, and convert research into product concepts, interfaces, and ergonomic designs.
• Proficiency in using low- and high-fidelity prototypes to identify and eliminate potential use errors early in development.
• Experience working in virtual development environments contributing to systems design, verification, and validation milestones.
• Strong communication skills and the ability to collaborate across mechanical, electrical, software, clinical, regulatory, safety, risk, and quality engineering disciplines.
• Solid oral and written communication, organizational, and technical problem‑solving skills; ability to work in teams, think critically, adapt to changing environments, and contribute to meaningful products.
• Practical knowledge of FDA human factors guidance, regulations, and standards (IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, design controls).

• A comprehensive employee benefits package, including retirement savings plan, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program and, for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work…