Sr. Mgr HFE & Use Risk Management

Job Description

The Sr. Mgr Human Factors Engineering (HFE) and Use Risk Management will work closely with cross-functional development teams to define the strategy, processes and deliverables for human factors activities from early stage to obsolescence across Amgen products. S/he will infuse a risk-based approach to human factors processes, activities, and deliverables that ensure quality, enable successful regulatory filings and product launches, and support post-market surveillance.

S/he will 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.

Responsibilities

The Sr. Manager HFE/UE responsibilities include but are not limited to:

• 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 systematic 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 best practices, guidance and standards.
• Analyze objective and subjective data from usability studies to inform design, inform 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.
• Actively communicate with internal and external key stakeholders.
• 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.

Basic Qualifications:

Doctorate degree and 2 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry

OR

Master's degree and 6 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry

OR

Bachelor's degree and 8 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry

OR

Associate's degree and 10 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry

OR

High school diploma / GED and 12 years of Human Factors Engineering, Usability Engineering, or Engineering in medical device or biotech industry

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 of industry experience, medical devices or combination products, non-combination product including large and small molecule products working in a matrixed and fast-paced corporation.
• Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge of applicable guidance, regulations and standards including: ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, 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.
• Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing.
• 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, expert 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 disciplines.
• 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.

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.