The Senior Human Factors Engineer plays a critical role in the design and development of rapid diagnostic products for global markets
Job Summary
The Senior Human Factors Engineer plays a critical role in the design and development of rapid diagnostic products for global markets.
This role applies advanced human factors engineering (HFE), usability science, and cognitive psychology to ensure safe, intuitive, and effective user interactions throughout the entire product lifecycle.
The position partners closely with R&D, Clinical, Regulatory, Quality, Marketing, and Design teams to generate high‑quality usability evidence and documentation supporting regulatory submissions and product commercialization.
Matching Summary
The Senior Human Factors Engineer plays a critical role in the design and development of rapid diagnostic products for global markets.
Skills & Requirements
Must-have
Human Factors Strategy & Execution
Usability studies planning and execution
User-centered design methodologies
Regulatory & Quality System Support
Cross-Functional Collaboration
Product lifecycle management
Nice-to-have
Investigate emerging technologies
Strengthen HFE capabilities
Influence across teams
Contribute to best practices
Key Requirements
6+ years planning, moderating, and analysing usability studies
Experience preparing HFER and FDA submission documentation
Experience generating IVDR usability evidence
Experience contributing to WHO PQDx submissions
Strong working knowledge of IEC 62366‑1, ISO 14971, FDA Guidance
Hands-on experience with diagnostic devices and IFUs