Engineer- Human Factors Engineer / Usability Engineer (HF/ UE)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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
Lets do this. Lets 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.
Manage HF aspects of project including: planning, timelines, landmarks, resources, priorities and budget requirements
Plan, conduct, analyze and report human factors activities supporting multiple projects
Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases
Ensure HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements
Ensure brand driven aesthetics are applied consistently across the entire product portfolio
Support usability testing 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
Assist in preparation for clinical studies and regulatory submissions in accordance with HF standard methodologies
Analyze objective and subjective data from usability studies to inform design and provide alternative solutions
Active communication with internal and external key partners
Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HF/UE reports
This position requires up to 25% yearly travel mostly local and domestic
Permanent remote work may be considered
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:
Masters degree or Master's degree completed by June 2021
Bachelors degree and 2 years of Engineering or Industrial Design experience
Associates degree and 6 years of Engineering or Industrial Design experience
High school diploma / GED and 8 years of Engineering or Industrial Design experience
Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering and 2+ years of business experience, working in multi-functional, fast-paced corporation
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
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
Experience in the front-end user needs identification, task analysis, URRA, specification development, risk assessments, testing, verification and validation
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
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
#Operations21Equal 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 UsIf 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.