Infrastructure Engineer specializing in VMware and Hyper - V for a leading financial services company. Join a high - performing team in managing large - scale IT infrastructures.
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
Job title
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Experience level
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Degree requirement
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