Senior Manager Human Factors Engineer - HF & Use Risk Management
Company: Amgen Inc.
Location: Thousand Oaks
Posted on: June 6, 2021
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Job Description:
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. 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. 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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.
Keywords: Amgen Inc., Thousand Oaks , Senior Manager Human Factors Engineer - HF & Use Risk Management, Other , Thousand Oaks, California
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