Job details
Job type full-time
Full job description
Career category
Engineering
Job description
How might you defy imagination?
You’ve earned your degreeHow 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 haveAt amgen, our shared mission—to serve patients—drives all that we doIt is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwideBecome the professional you are meant to be in this meaningful role.
Senior human factors engineer - usability
Live
What you will do
Let’s do thisLet’s change the worldIn this vital role you will responsible for leading human factors (hf) /usability engineer (ue) activities, planning, research, development of amgen drug delivery products using risk based approach and fit-for-purpose hf/ue methodologies in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries.
Key responsibilities include:
Represent hf / ue providing subject matter expertise (sme) guidance based upon best practices, hf/ue activities, industry regulations and hf / ue principles
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
Validation studies are well designed and executed
Prepare materials for regulatory engagements to secure alignment on program strategy
Implement a risk-prioritized, fit-for-purpose approach to hf activities
Ensure user capabilities and limitations and associated use-related risks are appropriate considered in planning, requirements development, ui-design evaluations, and design
Select hf study methodology to best meet objectives and develop that testing/study/research
Create and maintain use-related risk analysis and utilize to inform prioritization of risk and hf testing
Lead study design, protocol development, and execution of formative and summative (hf validation)
Execute moderation and/ or support note taking and analysis of study data for formative studies as appropriate and warranted
Lead vendor engagements to ensure sound hf/ue principles are applied throughout execution, analysis, and reporting
Lead analysis, reporting and integration of study findings
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
Ensure human-system capabilities and limitations are accurately reflected in the system requirements, and input utilized in requirements development.
Additional responsibilities include:
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.
Drive appropriate human factors and usability engineering activities to improve the product ui design of our combination and non-combination products such drug deliver devices, software, apps, packaging, labeling, and instructions for use while minimizing the potential for use errors.
Support and provide hf expertise for clinical studies and support interpretation of usability data collection as needed.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patientsThe highly organized professional we seek is a problem solver with these qualifications.
Basic qualifications:
Doctorate degree or
Master`s degree and 3 years of engineering or operations experience or
Bachelor`s degree and5 years of engineering or operations experience or
Associate`s degree and10 years of engineering or operations experience or
High school diploma/ged and 12 years of engineering or operations experience
Leading authority of principles and industry application of medical device and healthcare regulations including: fda’s human factors guidances, labeling for home use, iec-62366He 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.
Preferred qualifications:
Bachelor`s or master`s degree in human factors engineering (hfe), usability engineering, medical device, mechanical engineering, biomedical or systems engineering and 5-10 years of business experience, medical devices or combination products, working in cross functional, fast-paced corporation.
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.
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
Experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
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 optimization and risk based approach to development of highly usable products.
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 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
Travel requiredRemote work may be considered.
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