Human Factors Engineer​/System Problem-Solving Lead

Position: Human Factors Engineer / System Problem-Solving Lead (3+ Month Fixed Term Contract)
Location: Greater London

Entia’s mission is to transform the way health conditions are managed by removing the burden of blood monitoring and unlocking new insights that will keep people healthier for longer. The Liberty analyzer and cuvette technology is the cornerstone of this revolution and will allow us to offer comprehensive blood monitoring in the home for a wealth of health conditions.

Given the burden of cancer treatment on patients and the significant opportunities to redesign important and high-value care pathways, Entia has launched first into the oncology market.

Role Overview

Entia is preparing an FDA 510(k) submission for an at-home blood testing device for cancer patients. We are focused on ensuring that we deliver a seamless patient experience and as part of that, we want to maximise the overall ‘success rate’ of tests. We are looking for a contract specialist who can lead this effort, although ideally the right candidate would be able to move into a permanent role as a cross functional expert who can provide technical support for a variety of our future initiatives.

While further usability improvements is a major hypothesis for optimising the success rates of tests, we are seeking someone who can own the system-wide review and drive coordinated solutions across teams.

This role is ideal for a Human Factors Engineer or Systems engineer who is a strong cross-disciplinary problem-solver with medical-device experience who can produce FDA-credible usability documentation and lead structured root-cause analysis across the entire system if issues extend beyond usability.

What you’ll do 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.

You have:

• 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.

Success After 3 Months

• Clear, evidence‑backed attribution of success‑rate issues: usability vs system vs mixed.
• Mitigations implemented and/or validated, with measurable improvements in success rate.
• A near‑complete Human Factors Engineering Report and usability file for the 510(k).
• System‑level recommendations documented and aligned across engineering, product, and clinical teams.
• A clear path…