Engineer- Human Factors
The Human Factors Engineer (HFE) /Usability Engineer (UE) /Industrial Designer (ID) 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 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.
*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.
*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 working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience.
*Experience in the design and manufacturing scale-up of medical device/ injectable devices including user needs identification, specification development, risk assessments, testing, verification and validation.
*Medical Device, Observational Research and/or Combination Device experience
*Good understanding of the principles of Medical Device and healthcare regulations including Quality System Regulation (QSR), ISO 13485:2003, ISO 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, Design Controls 21 CFR 820, etc.
*The position requires strong oral and written communication and organizational skills, technical problem solving, the ability to work in teams, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
*Lift cartons at least 25 pounds, pick up used research supplies and equipment from the Amgen mail room, and lift and pack materials into cartons, cabinets both within the department, as well as to other Amgen buildings on campus.
*Experience w/ MS Office Word, Excel, PP, One Note, Project.