HOW MIGHT YOU DEFY IMAGINATION?
Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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
Lets do this! Lets 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.
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 human factors and usability engineering activities to improve the design of products, specifically the device-user interface. This includes the device, packaging, labeling, and instructions for use.
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/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.
Execute 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 25% 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:
Masters Degree in Biomedical/Pharmaceutical Field with Human Factors/Usability background OR
Bachelors Degree in Biomedical/Pharmaceutical Field and 2 years of Human Factors/Usability Engineering experience OR
Associate degree in Biomedical/Pharmaceutical Field and 6 years of Human Factors/Usability Engineering experience OR
High school diploma / GED and 8 years of Human Factors/Usability Engineering experience.
Bachelors or Masters degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering, or other relevant Engineering/HF subject area 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.
HF/UE 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
ThriveWhat 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.
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.