Senior Engineer - Senior Human Factors Engineer / Usability Engineer (HFE/UE)
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.
Come join us!
This opportunity is based in Thousand Oaks, CA and will help guide human factors and industrial design activities for development of Amgen drug delivery devices/systems. Collaborating with marketing, engineering, quality, manufacturing and regulatory team members, you will develop innovative and intuitive-to-use products through the application of human-centered design methodologies.
The Senior Engineer will work with the Director of Human Factors to focus on internal and external team activities, assuring brand driven aesthetics are applied consistently across the entire product portfolio. Planning, implementation and reporting of human factors engineering, user interface/industrial design studies across assigned device programs (according to current regulations and guidelines) is also part of this role. This individual will ensure that HF/ID input is provided to device design teams.
Additionally, the Senior Human Factors Engineer will ensure:
- Human-system capabilities and limitations are accurately reflected in the system requirements and Human-system performance and safety risks are appropriately addressed in program baseline.
- Being instrumental in addressing human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the anticipated costs to be incurred.
- Doctorate Degree
- Master's Degree & 3 years of Engineering or Operations experience
- Bachelor's Degree & 5 years of Engineering or Operations experience
- Associate's degree & 10 years of Engineering or Operations experience
- High school diploma/GED & 12 years of Engineering or Operations experience
Master's degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology, and 6+ years of business experience, working in development organizations in multiple parallel and virtual development environments
4+ years experience working within the development of electro-mechanical systems design, verification and validation
Excellent organizational, technical problem solving and interpersonal skills (written and verbal), the ability to work in teams, adapt to a constantly evolving environment, and lead external design consultants
Leading authority of principles and industry application of Medical Device and healthcare regulations including: FDA's Human Factors Guidances, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15
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/minimally invasive drug delivery systems (e.g. pulmonary, transdermal)
Experience working directly with customers 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.
Proven experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
Amgen offers a very robust compensation and benefits package and is an Equal Opportunity employer. Amgen 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.
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.