Alex Cole

About Alex Cole

I am an experienced biomedical and human factors engineer working in medical devices. I…

Experience

1. Human Factors Engineer

   Genentech

   Jun 2021 — Present

   Apply principles of human factors engineering and user-centered design during the design, development, testing, and risk assessment of medical devices and combination products. Assist in the authoring and review of human factors plans, intended use statements, task analyses, use-related risk assessments, formative study protocols and reports, and informed consents in line with SOPs and FDA Guidance. Lead HFE/UE efforts, including study moderation, for internal evaluations of adherence packaging, a thrombolytic drug dosing guide, and a Class 1 surgical instrument. Author instructions for use (IFU) including obtaining graphics from external vendors when necessary. Participate in internal subject matter expert HF evaluations, including heuristic evaluations. Observe formative and summative human factors studies and participate in root cause analysis for multiple products. Lead efforts for sourcing external vendors and complete activities associated with working with external vendors for study planning and execution.