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Amgen Engineer- Human Factors Engineer / Usability Engineer (HF/ UE) in Thousand Oaks, California

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Engineer- Human Factors Engineer / Usability Engineer (HF/ UE)

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will contribute to and facilitate HF/UE research, development and continuous improvement activities of Amgen drug delivery devices using HF/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. HF/UE must effectively collaborate with internal and external partners and across functions with marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams. Implement human factors research to drive innovative and intuitive products. HF/UE will support appropriate human factors and usability engineering activities to ensure the product user interface-design adequately supports safe and effective use.

Role Responsibilities:

  • 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 meaningful and actionable data to inform UI-design and risk

  • validation studies are well designed and executed

  • 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

  • Analyze objective and subjective data from usability studies to inform design and provide alternative solutions

  • Execute moderation and/ or support note taking and analysis of study data for formative studies as appropriate and warranted

  • 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

  • Active communication with internal and external key partner

  • This position requires up to 25% yearly travel mostly local and domestic

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

  • Master’s degree or Master's degree completed by June 2021 OR

  • Bachelor’s degree and 2 years of Engineering or Industrial Design experience OR

  • Associate’s degree and 6 years of Engineering or Industrial Design experience OR

  • High school diploma / GED and 8 years of Engineering or Industrial Design experience

Solid foundation and applicable experience in Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge and practical application of relevant guidance, regulations and standards including: Combination product experience including functional knowledge of applicable guidance, regulations and standards including: Applying Human Factors and Usability Engineering to Medical Devices, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA, Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications, Safety Considerations for Product Design to Minimize Medication Errors, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products— Content and Format, Design Considerations for Devices Intended for Home Use, Labeling for Biosimilar Products, Current Good Manufacturing Practice Requirements for Combination Products, IEC 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, Council Directive 93/42/EEC, ISO 14971, EU MDR, Quality by Design (QbD), 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

Preferred Qualifications :

  • Bachelor's or Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering, or other relevant Engineering, HF discipline and 3-5 years of industry experience, working in multi-functional, fast-paced corporation

  • HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support

  • Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, professional analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies

  • 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.

  • Execute 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.

  • 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 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.

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 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.

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