HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Director - Human Factors Engineering/Usability EngineeringLive
What you will do
Lets do this. Lets change the world. The successful Director of Human Factors/Usability Engineering will manage a team of human factors and usability engineering professionals and provide strategic leadership for the successful commercialization of Amgens pharmaceuticals and combination products, taking into consideration the user, the intended use, the use environment (eco-system), and the drug therapies being administered.
Their team is appropriately supervised to achieve the companys prioritized product advancement or lifecycle management efforts from the human factors and usability engineering perspective
Any challenges or risks in accomplishing the companys prioritized work are communicated to the Executive Director of Combination Product Operations Excellence in a timely manner, including mitigation options
Their team receives ongoing feedback for career development
Their team has project plans that have:
- Properly reflected human-system capabilities and limitations in the system requirements
- Appropriately addressed Human-system performance and safety risks in the program baseline
- Identified the human factors and human performance measures and thresholds to be achieved (e.g., for the equipment, software, environment, support concepts, and configurations expected for the solution)
- Resolved human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
- Doctorate degree and 4 years of Engineering or Applied Human Factors/Industrial Design Engineering experience OR
- Masters degree and 8 years of Engineering or Applied Human Factors/Industrial Design Engineering experience OR
- Bachelors degree and 10 years of Engineering or Applied Human Factors/Industrial Design Engineering experience AND 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
- Master's degree in Human Factors (HF), Industrial Design (ID), Cognitive Psychology, or other Engineering/Life Sciences related subject area
- 10+ years of business experience, leading development organizations in multiple parallel and virtual development environments
- Certified Professional Ergonomist (CPE), Certified Human Factors Professional (CHFP), Certified User Experience Professional (CUXP), Associate Ergonomics Professional (AEP), Associate Human Factors Professional (AHFP), Associate User Experience Professional (AUXP) or Certified Ergonomics Associate (CEA)
- 8+ years of experience working in the development of electro-mechanical systems design, verification, and validation
- Strong background with requirements management, configurations management, defect tracking, and requirements tracking tools
- Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected
- Experience with complex, multi-functional development projects; Proven leadership and experience leading multiple projects with high-demand schedules
- Experience working with and leading cross-cultural teams
- Proven ability to apply situational leadership concepts across various intra and inter-departmental matters
- Demonstrated time management, decision making, presentation, and organization skills
- Excellent organizational, technical problem solving, negotiation, 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
- Previous experience in Human factors/instructional design engineering and commercialization process with drug delivery devices and combination drug/device products
- Human factors/instructional design 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 subject areas
- Proven experience in the Human factors/instructional design principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis
- 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
- Thorough knowledge of relevant human factors regulations, standards and guidance for combinational products, 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, 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 in management of external partners and suppliers
- Experience with establishing program objectives following company policies and establishing procedures that are measurable with outcomes can be quantified
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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
Join UsIf 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.
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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.