The Human Factors Engineer (HF/ID) will help guide human factors and industrial design activities for development of Amgen drug delivery devices/systems taking into consideration all aspects of the user, the intended use, the use environment (eco-system), and the drug therapy being delivered. The Human Factors Engineer will collaborate with marketing, engineering, quality, manufacturing and regulatory team members to create innovative and intuitive-to-use products through the application of human-centered design methodologies through Usability assurance, determination of desired user profiles, and user documentation.
The Human Factors Engineer will work with the Director of Human Factors to collaborate with internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio. They will help with planning, execution and reporting of human factors engineering, user interface and industrial design studies across assigned device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries, ensuring that expert HF/ID input is provided to device design teams for enforcing design requirements, packaging requirements, training requirements and use instructions, design validation activities and clinical studies in support of regulatory submissions.
Ensures Human-system capabilities and limitations are properly reflected in the system requirements
Assist in determining Human-system performance and safety risks are appropriately addressed in program baseline
Assist in determining the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred
25% yearly travel
Bachelor's degree and 2 years of Human Factors Engineering experience
Associate's degree and 6 years of Human Factors Engineering experience
High school diploma / GED and 8 years of Human Factors Engineering experience
Bachelor's degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology, or and 2+ years of business experience, working in development organizations in multiple parallel and virtual development environments
MS in Human Factors, Industrial Design, Cognitive Psychology. Other Engineering/Life Sciences related disciplines
1+ year experience working in the development of electro-mechanical systems design, verification and validation
Demonstrated time management, decision making, presentation and organization skills
HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal)
Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
Excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external design consultants
Experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis
Experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market
Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction
Knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging
Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485:2003, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, etc.
Experience in design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of medical device development
Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports)
Experience working in multiple projects with high demand schedules
Experience in collaboration with external partners
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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 cancer, 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.
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