Amgen

Sr Human Factors Engineer / Usability Engineer

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Feb 11, 2019
Ref
R-61367
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Sr. Human Factors Engineer (HFE) / Usability Engineer (UE) is responsible for leading HFE/UE planning, research, development of Amgen drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. 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. Lead project study design, methodology, data collection, root cause analysis to inform design. Apply sound HFE/UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions.

Responsibilities

The Sr. HFE/UE responsibilities include but are not limited to:
  • 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/ID 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.
  • 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 and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices.
  • Actively communicate with internal and external key stakeholders.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.


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

Basic Qualifications:

Doctorate Degree

OR

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

OR

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

OR

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

OR

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

Preferred Qualifications: -
  • Master's degree in Human Factors Engineering (HFE), Usability Engineering, Medical Device, Mechanical Engineering, Biomedical or Systems Engineering and 5+ years of business experience, medical devices or combination products, working in cross 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 and independently executing 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.
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.
  • 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.
  • Combination product experience including functional knowledge of applicable guidance, regulations and standards including: ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, 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


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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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