30 days old

Sr. Human Factors Engineer (HFE) /Usability Engineer (UE)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    120014026
Amgen

Job ID: R-98408
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Massachusetts - Cambridge

The Sr. Human Factors Engineer (HFE) /Usability Engineer (UE) is responsible for leading all aspects of HFE/UE planning, research, development, and life cycle management of Amgen products using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. S/he will use insights, user needs, preliminary HF analyses, task analyses, use-related risk analyses, and formative testing as inputs into design and development of Amgen portfolio..

Collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. Implement human factors research driving innovative, intuitive, and useful products. Apply HFE/UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions.

The Sr. HFE/UE responsibilities include but are not limited to:
  • Work collaboratively with engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across Amgen portfolio or programs.
  • Lead and/or conduct to usability activities such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.
  • Ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements.
  • 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.
  • Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative solutions.
  • Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.
  • Lead 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, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry experience

OR

Bachelor's degree and 5 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry experience

OR

Associate's degree and 10 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry experience

OR

High school diploma / GED and 12 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry experience

Preferred Qualifications:
  • Master's degree in Human Factors Engineering (HFE), Usability Engineering, Mechanical Engineering, Biomedical or Systems Engineering and 5+ years of industry experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrixed and fast-paced corporation
  • 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, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies.
  • 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
  • Combination product experience including functional knowledge of applicable guidance, regulations and standards including: FDA's Human Factors Guidance, 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, 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 801.1


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.



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Posted: 2020-05-01 Expires: 2020-06-01

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Sr. Human Factors Engineer (HFE) /Usability Engineer (UE)

Amgen
Thousand Oaks, CA 91360

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