Senior Manager Human Factors Engineer - HF & Use Risk Management

Senior Manager Human Factors (HF) Engineer - HF & Use Risk Management

Live

What you will do

Lets do this. Lets change the world. In this vital role, S/he will work withHF/UE & Instructional-Design leadership and cross-functionally to develop fit-for-purpose, risk-prioritized HF/UE program strategies across a range of Amgen products. S/he will provide strong leadership and Subject Matter Expertise (SME) to ensure use-related risk management is embedded, understood, and utilized appropriately, throughout the product lifecycle, integrating industry best practices and in accordance with state-of-the-art applicable HF Guidance(s), Standard(s), and Regulation(s).

• Provides leadership, SME inputs, and education of use-related risk management including integration of known and foreseeable use, preliminary HF analyses, task analyses, use-related risk analyses, user-interface design, managing creation and maintenance of Usability Engineering Files.
• 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,
  • risk control mitigations are evaluated appropriately,
  • validation studies are well designed and executed

• Leads analysis /provides oversight for HF/UE study design, data collection, data analysis, root cause analysis, reporting, and integration of study findings/mitigation strategies to optimize UI-design and reduce potential for use errors / medication errors.
• Create strategy, author, and review materials to support clinical studies, regulatory engagements and submissions applying industry best practices and in accordance with state the artapplicable HF Guidance(s), Standard(s), and Regulation(s).
• Ensure Human-system capabilities and limitations are accurately reflected in the use specification and appropriate inputs are incorporated in requirements development.
• Lead vendor engagements to ensure sound HF/UE principles are applied throughout execution, analysis, and reporting
• Provide leadership support for 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.
• 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
• This position requires up to 25% yearly travel mostly local and domestic.
• Permanent remote may be considered.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The strategic professional we seek is an engineer with these qualifications.

Basic Qualifications:

Leading authority of principles and industry application of Medical Device and healthcare regulations including: FDAs Human Factors Guidances, Labeling for home use, 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, 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, ISO 14971, FDA Draft Guidance Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products.

Education Qualification:

• Doctorate degree and 2 years of relevant industry experience OR
• Masters degree and 6 years of relevant industry experience OR
• Bachelors degree and 8 years of relevant industry experience OR
• Associates degree and 10 years of relevant industry experience OR
• High school diploma / GED and 12 years of relevant industry experience
• and 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Bachelor's Degree or Masters degree in Human Factors, Mechanical Engineering, Usability Engineering, Biomedical, Biomechanical Engineering, Systems Engineering, Human-Computer Interaction,or other relevant Engineering Disciplines with 8-12 or 6-8 years respectively of relevant industry experience.
• Demonstrated success applying HF principles in medical device, combination products, and non-combination products including large and small molecules working in a matrixed and fast-paced organization
• Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, etc.
• Experience leading various HF methodologies such as planning, coordinating, conducting, analyzing, and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, etc.
• Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.

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.

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.