Principal Engineer - Human Factors Engineer / Usability Engineer (HF/ UE)
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. Join us.
Principal Engineer Human Factors Engineer / Usability Engineer (HF/ UELive
What you will do
Lets do this. Lets change the world. In this vital role you will work closely with multi-functional development teams to define the End-to-End strategy for HF/UE across Amgen's diverse products. S/he will infuse a risk-prioritized approach throughout development phases of device and combination products to support regulatory filing, product launch, and post-market surveillance HF/UE activities. S/he will provide domain expertise in HF/UE activities including integration of known and foreseeable use, preliminary HF analysis, task analysis, use-related risk analysis, testing strategies, study design, execution, and analysis, and creation and maintenance of Usability Engineering Files.
Represent HF / UE as a subject matter expert (SME) for HF/UE in combination and non-combination products space. Support continuous improvement efforts to implement and practice risk based approach and fit-for-purpose methodologies in accordance with with agency guidance, industry best practices, HF / UE principles, standards and regulations.
- Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure:
- appropriate inputs are collected,
- context of use/ use spec is clearly defined,
- insights properly translated into user needs,
- known use problems are considered during UI-design, preliminary analysis, and use-related risk analysis(URRA)
- URRA guides HF testing strategy,
- formative studies are designed fit-for-purpose based upon objectives, scope, phase of project and executed to deliver meaning data to inform UI-design and risk
- validation studies are well designed and executed
- Prepare and review materials for regulatory engagements to secure alignment on program strategy
- Ensure user capabilities and limitations and associated use-related risks are appropriate considered in planning, requirements development, UI-design evaluations, and design
- Select HF study methodology to best meet objectives and develop that testing/study/research
- Create and maintain use-related risk analysis and utilize to inform prioritization of risk and HF testing
- Lead study design, protocol development, and execution of formative and summative (HF validation)
- Execute moderation and/ or support note taking and analysis of study data for formative studies as appropriate and warranted
- Lead vendor engagements to ensure sound HF/UE principles are applied throughout execution, analysis, and reporting
- Lead analysis, reporting and integration of study findings including mentoring other staff
- Prepare documentation to support development activities, design controls, DHF, UEF, DMR including use specification, study protocol, task analysis use-related risk analysis (TA- URRA), usability assessment, HF validation report for inclusion in regulatory filing and subsequent post-marketing needs
- Ensure Human-system capabilities and limitations are accurately reflected in the system requirements, and input utilized in requirements development.
This position requires up to 20% yearly travel mostly local and domestic
Permanent Remote may be considered
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The human factors professional we seek is a self-starter with these qualifications.Basic Qualifications:
- Doctorate degree and 2 years of Human Factor Engineering industry experience OR
- Masters degree and 6 years of Human Factor Engineering industry experience OR
- Bachelors degree and 8 years of Human Factor Engineering industry experience OR
- Associates degree and 10 years of Human Factor Engineering industry experience OR
- High school diploma / GED and 12 Human Factor Engineering industry experience
Leading authority of principles and industry application of Medical Device and healthcare regulations including: FDAs 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 801.15Preferred Qualifications:
Bachelor's or Master's degree in Human Factors Engineering (HFE), Usability Engineering, Mechanical Engineering, Biomechanical, Biomedical or Systems Engineering, or other relevant Engineering discipline and 8-15 years of industry experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrix and fast-paced corporation
- Work collaboratively with engineering, design, commercial, and product teams to ensure successful translation of customer requirements into products that are safe and effective for user and enrich the overall user experience across Amgen portfolio or programs.
- Drive 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.
- Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF standard methodologies.
Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering subject areas
Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience
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
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.Amgen requires all staff in the United States and Puerto Rico 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.