Senior Human Factors Engineer - Usability

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Human Factors Engineer - Usability

Live

What you will do

Lets do this. Lets change the world. In this vital role you will represent Human Factors/ Usability Engineering (HF/UE) providing subject matter expertise (SME) standard methodologies, HF/UE activities, industry regulations and HF / UE principles statement connecting primary position responsibility to employer brand.

Role Responsibilities:

• Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure:

• appropriate inputs are collected, context/ conditions of use is clearly defined, insights properly translated into user needs, known use problems are considered during UI-design, preliminary analysis, and use-related risk analysis 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 materials for regulatory engagements to secure alignment on program strategy

• Implement a risk-prioritized, fit-for-purpose approach to HF activities

• 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 deliverable 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 results analysis, and reporting

• Lead analysis, reporting and integration of study findings

• 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

• Analyze objective and subjective data from usability studies to inform UI-design, inform risk mitigations, and provide alternative solutions

• 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

• Support 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

• Communicate regularly with internal and external key partners

• Apply detailed risk-prioritized process including identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective

• Conduct comprehensive use-related risk analysis (URRA) to ensure that all use-related risks have been mitigated and reduced to an acceptable level

• Identifying and mitigating known use problems to ensure that the combination product will not be prone to the same user interaction issues upon commercialization

• Permanent remote work may be considered.

Win

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

OR

Masters degree and 3 years of human factors/engineering industry experience

OR

Bachelors degree and 5 years of human factors/engineering industry experience

OR

Associates degree and 10 years of human factors/engineering industry experience

OR

High school diploma / GED and 12 years of human factors/engineering industry experience

Preferred Qualifications:

• Master's degree in Human Factors Engineering (HFE), Usability Engineering, Medical Device, Mechanical Engineering, Biomedical or Systems Engineering and 4-6 years of business experience, medical devices or combination products, working in multi-functional, fast-paced corporation.

• Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing.

• Experience leading various HF methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, specialist analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies.

• Experience designing and conducting formative studies beyond typical simulated-use.

• 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.

• Combination product experience including functional knowledge of applicable guidance, regulations and standards including: IEC 62366, HE75, ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, 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

• Permanent remote work may be considered.

Join Us

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.