Human Factors Engineering Lead | Medical Devices | UX & Product Safety
Listed on 2026-06-24
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Engineering
Biomedical Engineer, Medical Device Industry, Product Engineer, Quality Engineering
Human Factors Engineering Lead / Associate Engineering Fellow (Medical Devices)
Design for humans. Enable safety. Shape the future of medical devices.
A global biopharma leader is seeking a Human Factors Engineering Lead (Associate Engineering Fellow) to drive human-centred design across medical devices and combination products. This is a senior, high-impact role at the intersection of engineering, user experience, and patient safety
.
If you’re passionate about translating user needs into safe, intuitive, and compliant product experiences—this is a standout opportunity.
What you’ll do:- Lead Human Factors Engineering (HFE) strategy aligned with global regulatory requirements
- Drive user research and translate insights into product and system-level requirements
- Shape end-to-end user experience across hardware, software, packaging, labelling, and instructions
- Design and execute usability studies, validation protocols, and risk analyses
- Conduct task analysis and use-related risk assessments to ensure product safety
- Develop Human Factors documentation (validation reports, summary reports, usability engineering files)
- Collaborate cross-functionally with engineering, clinical, regulatory, and quality teams
- Manage external vendors across HFE, industrial design, and user research
- Support regulatory submissions and audits (FDA, IEC, ISO standards)
- Mentor and guide other HFE professionals
- Extensive experience in Human Factors Engineering within medical devices or biotech
- Strong knowledge of regulatory frameworks (FDA, IEC, ISO) and design controls
- Expertise in usability engineering, risk analysis, and human-centred design
- Proven ability to lead complex product development programmes
- Strong stakeholder management and cross-functional collaboration skills
- PhD + 7+ years, OR
- Master’s + 13+ years, OR
- Bachelor’s + 15+ years in Human Factors, Biomedical, Industrial Engineering, or similar
This is more than engineering—it’s an opportunity to directly impact patient safety and product usability at a global scale
, influencing how life-changing medical technologies are designed and experienced.
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