Entia

Human Factors Engineer – System Problem-Solving Lead

Entia

contract

Posted on:

Location Type: Hybrid

Location: London • 🇬🇧 United Kingdom

Visit company website
✨ AI Apply
Apply

Job Level

Senior

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Human Factors EngineeringUsability EngineeringSystems EngineeringBiomedical EngineeringRoot Cause AnalysisTask AnalysisUse-Error AnalysisStatistical AnalysisRegulatory Documentation510(k) Submissions
Soft skills
LeadershipCollaborationProblem-SolvingCommunicationAdaptability