Senior Human Factors Engineer - Usability
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.
Senior Human Factors Engineer - Usability
What you will do
Let's do this. Let's change the world. In this vital role you will responsible for leading Human Factors Engineer (HFE) /Usability Engineer (UE) planning, research, development of Amgen drug delivery devices using HFE/UE standard methodologies and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries.
- 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 accurately 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 standard methodologies.
- Communicate regularly with internal and external key partners.
- Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.
- Apply detailed risk-based 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The highly organized professional we seek is a problem solver with these qualifications.
Master's Degree and 3 years of Engineering or Operations experience
Bachelor's Degree and5 years of Engineering or Operations experience
Associate's degree and10 years of Engineering or Operations experience
High school diploma/GED and 12 years of Engineering or Operations experience
- Master's degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology
- Experience, working in development organizations in multiple parallel and virtual development environments
- Experience working within the development of electro-mechanical systems design, verification and validation
- Excellent organizational, technical problem solving and interpersonal skills (written and verbal), the ability to work in teams, adapt to a constantly evolving environment, and lead external design consultants
- Leading authority of principles and industry application of Medical Device and healthcare regulations including: FDA's Human Factors Guidances, 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, 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
- HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive/minimally invasive drug delivery systems (e.g. pulmonary, transdermal)
- Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs.
- Experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
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.