Senior Manager Human Factors Engineer - HF & Use Risk Management

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

Live

What you will do

Let's do this. Let's change the world. In this vital role work closely with multi-functional development teams to define the strategy, processes and work for human factors activities from early stage to obsolescence across Amgen products. Infuse a risk-based approach to human factors processes and activities that ensure quality, enable successful regulatory filings and product launches, and support post-market surveillance.

• Provide guidance in HFE activities including integration of known and foreseeable use, preliminary HF analyses, task analyses, use-related risk analyses, user-interface design, and facilitating creation and maintenance of Usability Engineering Files.
• 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.
• 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.
• Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF standards, guidance and standards.
• Analyze objective and subjective data from usability studies to give mentorship on design, counsel risk minimization, and provide alternative solutions.
• Provide 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.
• This position requires up to 25% yearly travel mostly local and domestic.

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:

Doctorate degree and 2 years of relevant industry experience
OR

Master's degree and 6 years of relevant industry experience
OR

Bachelor's degree and 8 years of relevant industry experience
OR

Associate's 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:

• Master's degree in Human Factors Engineering (HFE), Usability Engineering, Mechanical Engineering, Biomedical or Systems Engineering and 10 years demonstrated ability with medical devices or combination products, non-combination product including large and small molecule products working in a matrixed and fast paced organization
• Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge of applicable guidance, regulations and standards
• 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 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

Apply now

for a career that defies imagination

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

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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.