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

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

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

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will contribute to and facilitate HF/UE research, development and continuous improvement activities of Amgen drug delivery devices using HF/UE standard processes and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. HF/UE must effectively collaborate with internal and external partners and across functions with marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams. Implement human factors research to drive innovative and intuitive products. HF/UE will support appropriate human factors and usability engineering activities to ensure the product user interface-design adequately supports safe and effective use.

Role Responsibilities:

• Partner multi-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure Amgen products are safe and effective for end users.

• Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.

• Implement a risk-prioritized, suitable approach to HF activities.

• Ensure Human-system capabilities and limitations are accurately reflected in the system requirements, and HFE/UE/Instructional Design input is provided across functions to develop device design, packaging, labeling, and training requirements.

• Analyze objective and subjective data from usability studies to inform design and risk minimization activities, as well as provide alternative patient and user solutions.

• Implement moderation and/ or support note taking and analysis of study data for formative studies.

• Prepare documentation to support development activities, design controls, DHF, UEF, DMR including use specification, study protocol, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports for inclusion in regulatory filing and subsequent post-marketing needs.

• Communicate regularly with key internal and external partners.

This position requires up to 10-15% yearly travel, mostly domestic US.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly organized professional we seek is a problem solver and has the requisite training and experience to be an effective contributor and team members.

Basic Qualifications:

• Master's Degree in Biomedical/Pharmaceutical Field with Human Factors/Usability background,

Or

• Bachelor's Degree and 2 years of Human Factors/Usability Engineering experience,

Or

• Associate degree and 6 years of Human Factors/Usability Engineering experience.

Or

• High school diploma / GED and 8 years of Human Factors/Usability Engineering experience.

Preferred Qualifications:

• Bachelor’s or Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering, or other relevant Engineering/HF field and 3-5 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 formative human factors studies without vendor support.

• Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, professional analysis, task analysis, hazard analysis, risk assessment, formative study 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 guidance, regulations and standards.

The position requires strong oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $97,068 - $126,183.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.