Sr. Mgr, Human Factors Engineering
The Sr. Manager, Human Factors Engineer (HFE) /Usability Engineer (UE) is responsible for leading HFE/UE planning, research, development of Amgen drug delivery devices using HF/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. Provide expert HFE/UE input is provided to device design and development teams for establishing design, packaging and labeling requirements. Ensure that HFE/UE expertise is applied to create and complete design validation activities and clinical studies in support of regulatory submissions. Collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams to implement human factors research to drive innovative and intuitive products. HFE will support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
The HFE/UE responsibilities include but are not limited to:
- Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget required supporting multiple projects.
- Ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements.
- Lead and provide expertise to usability testing 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.
- Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
- 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.
- Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices.
- 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.
Doctorate degree and 2 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry.
Master's degree and 6 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience
Bachelor's degree and 8 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience,
Associate's degree and 10 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience,
High school diploma / GED and 12 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience,
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Master's degree in Human Factors Engineering (HFE), Usability Engineering, Medical Device, Mechanical Engineering, Biomedical or Systems Engineering and 6 years of business experience, medical devices or combination products, working in cross functional, fast-paced corporation.
- 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.
- Combination product 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