Hybrid Human Factors Engineer – System Problem-Solving Lead

at Entia

• Job title: Human Factors Engineer – System Problem-Solving Lead
• Job type: Contract
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, London, United Kingdom

About the role

• Lead Human Factors Engineer for at-home blood testing device development. Focus on FDA submissions, usability improvements, and cross-functional collaboration within a startup environment.

Responsibilities

• 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.

Requirements

• 5+ years in Human Factors Engineering, usability engineering, systems engineering, biomedical engineering, or equivalent medical-device problem-solving role.
• Experience supporting or delivering 510(k) submissions, especially for consumer-use or home-use devices.
• Strong grounding in ISO 62366-1, FDA HF guidance, and ISO 14971 risk management.
• Demonstrated ability to lead cross-functional root-cause investigations that span usability and system behaviour.
• Experience running human-factors testing (formative/summative) and synthesising evidence into regulatory-ready documentation.
• Comfortable working in a fast-paced, ambiguous startup environment.

Benefits

• A fun and collaborative environment where you get to join a start-up transforming the delivery of cancer care
• We give you the tools and the tech you need to get you going
• Regular company events and social activities
• 38 Days Holiday annually (Inclusive of Bank Holidays)
• A flexible work environment - our culture is built on trust
• Monthly training budget
• Professional development and career progression - we want you to achieve your greatest potential here
• Collaborations with world-leading research institutions, healthcare providers and companies