Top 3 Must Have Skill Sets:

• 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.


• 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• Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical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 801.15


• Strong collaboration

Day to Day Responsibilities:

• 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.

Red Flags:

• NO industry experience in Human Factors Engineering / Usability Engineering in medical device or combination products. Limited travel or requires working remotely.


• All academia, degree heavy with little to know industry experience.