Engineer- Human Factors Engineer / Usability Engineer (HFE/ UE)
The Human Factors Engineer (HFE) /Usability Engineer (UE) shall contribute to and facilitate HFE/UE research, development and continuous improvement activities 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. HFE/UE collaborates with internal and external partners and across functions with marketing, engineering, quality, manufacturing, and regulatory teams. 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. Responsibilities include:
- Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget requirements.
- Plan, conduct, analyze and report human factors activities supporting multiple projects.
- Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Life Cycle Management phases.
- Ensure HFE/UE/ID input is provided across functions to develop device design, packaging, labeling, and training requirements.
- Ensure brand driven aesthetics are applied consistently across the entire product portfolio.
- Support 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.
- Assist in preparation for clinical studies and regulatory submissions in accordance with HF best practices.
- Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
- Active communication with internal and external key stakeholders.
- Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.
This position requires up to 25% yearly travel mostly local and domestic.
Master's degree or Master's degree completed by May 2018
Bachelor's degree and 2 years of Engineering or Industrial Design experience
Associate's degree and 6 years of Engineering or Industrial Design experience
High school diploma / GED and 8 years of Engineering or Industrial Design experience
- Master's degree in Human Factors, HFE/Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering and 2 years of business experience, working in cross functional, fast-paced corporation.
- Combination product experience including functional knowledge of applicable guidance, regulations and standards including: FDA's Human Factors Guidance, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, 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 801.1
- HFE/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.
- Experience with various HF methodologies such as 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.
- Experience in the front-end user needs identification, task analysis, URRA, specification development, risk assessments, testing, verification and validation.
- 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.
- Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis
- Skills in Microsoft Word, Excel, PowerPoint, and Outlook.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.