Senior Human Factors Engineer (HFE) / Usability Engineering (UE)

Amgen • Thousand Oaks, CA

268d • $133,270 - $166,594 • Remote

About The Position

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• High school diploma / GED and 10 years of Human Factors Engineering/Usability Engineering experience OR Associate's degree and 8 years of Human Factors Engineering/Usability Engineering experience OR Bachelor's degree and 4 years of Human Factors Engineering/Usability Engineering experience OR Master's degree and 2 years of Human Factors Engineering/Usability Engineering experience OR Doctorate degree.

Nice To Haves

• Medical device, combination product, non-combination product experience including functional knowledge of applicable guidance, regulations and standards.
• Master's degree in Human Factors Engineering (HFE), Usability Engineering, Biomedical or Systems Engineering and 5+ years of industry experience.
• Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations.
• Experience leading various HF methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups.
• Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, and quality engineering disciplines.

Responsibilities

• Work collaboratively with HFE, engineering, design, commercial, and product teams to ensure successful translation of user requirements into products.
• Create user interface (UI) requirements that meet the needs of users and enrich the overall user experience across Amgen's portfolio or programs.
• Lead usability activities such as study planning/coordination/management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment.
• Lead usability data analysis and HFE design history file documentation to support project needs.
• Collaborate with senior HFE team members to ensure human-system capabilities and limitations are properly reflected in the system requirements.
• Lead appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces.
• Analyze objective and subjective data from usability studies to inform design and provide alternative design controls/solutions.
• Lead and/or support HF Lead in preparation for clinical studies and regulatory submissions.
• Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, comparative analysis, HFE reports, data verification, and regulatory submissions.
• Actively communicate with internal and external key stakeholders.
• Exercise critical thinking & educated HFE judgement to determine appropriate next steps/actions.

Benefits

• 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.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree