Entia

Engineer

• System-Wide Root Cause Analysis
• Lead a rapid, structured investigation into Liberty’s sample-success failures across usability, sampling, workflow, error recovery, hardware, firmware, image processing, and environmental factors.
• Distinguish between use-related issues and device/system behaviour; provide evidence-based conclusions.
• Coordinate with engineering, product, and clinical teams to ensure no root cause domain is missed.
• Usability & Human Factors Activities
• Conduct task analyses, use-error analyses, and critical-task identification per ISO 62366-1.
• Diagnose and mitigate usability issues through improvements to instructions, UI/UX, sampling workflow, and training materials.
• Design and run formative evaluations; support summative usability validation for 510(k).
• Produce FDA-compliant HF deliverables, including URRA, formative reports, and the Human Factors Engineering Report.
• Design & Workflow Mitigation
• Recommend pragmatic changes to device behaviour, software, workflow cues, and instructions to increase success rate.
• Collaborate with engineering to test changes related to mechanical tolerances, optical/imaging readiness, and sample adequacy.
• Validate mitigations through evidence-based testing and statistical analysis.
• Regulatory-Ready Documentation Preparation
• Prepare (or contribute significantly to) the human-factors components of the 510(k), including structured justification for risk controls and mitigation choices.
• Ensure usability and system-behaviour evidence is correctly linked within design controls.

Human Factors Engineer – System Problem-Solving Lead