Principal Engineer - Human Factors & Use Risk Management
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Principal Human Factors Engineer - Use Risk ManagementLive
What you will do
Lets do this. Lets change the world. In this vital role you will work closely with multi-functional development teams to define the End-to-End strategy for HF/UE across Amgen's diverse products. S/he will infuse a risk-prioritized approach throughout development phases of device and combination products to support regulatory filing, product launch, and post-market surveillance HF/UE activities. S/he will provide domain expertise in HF/UE activities including integration of known and foreseeable use, preliminary HF analysis, task analysis, use-related risk analysis, testing strategies, study design, execution, and analysis, and creation and maintenance of Usability Engineering Files.
Work collaboratively with engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to build user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across Amgen portfolio or programs.
Apply detailed risk-prioritized process including identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective.
Collaborate multi-functionally build and maintain use related risk analyses (URRA) to ensure that all use-related risks have been mitigated and reduced to an acceptable level.
Support and provide HF/UE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards.
Analyze objective and subjective data from usability studies to inform design, advise risk minimization, and provide alternative solutions.
Integrating known and foreseeable use issues, analyzing human factors data, supporting root cause analysis (RCA) activities, evaluating use related risk, synthesizing findings, authoring and reviewing submissions.
Analyze complaints from on-market products for usability-related issues.
Guide and support 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.
Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.
Actively connect with internal and external key partners.
This position requires up to 20% yearly travel mostly local and domestic.
Permanent Remote may be considered.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The human factors professional we seek is a self-starter with these qualifications.Basic Qualifications:
Doctorate degree and 2 years of Human Factor Engineering industry experience
Masters degree and 6 years of Human Factor Engineering industry experience
Bachelors degree and 8 years of Human Factor Engineering industry experience
Associates degree and 10 years of Human Factor Engineering industry experience
High school diploma / GED and 12 Human Factor Engineering industry experiencePreferred Qualifications:
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
Master's degree in Human Factors Engineering (HFE), Usability Engineering, Mechanical Engineering, Biomedical or Systems Engineering and plus 6-8 years of experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrix and fast-paced corporation
Experience in front-end feasibility phase, exploratory research, user needs translation, conceptualization concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing
Extensive 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, professional 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 subject areas
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
Permanent remote work may be considered
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.