Senior Human Factors Engineer (all gender)
Core
Responsible for Usability Engineering and Design Validation in agile development projects from concept to market launch, ensuring safe and intuitive use by patients and non-expert users.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Medical devices and In-vitro-Diagnostic (IVD) products
Domain
MedTech / Regulatory Compliance (IEC 62366, FDA, MDR)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Usability Engineering, Design Validation, User Testing Planning & Execution, Regulatory Documentation (IEC 62366, FDA, MDR), Risk Analysis, Stakeholder Management, Agile/SCRUM facilitation, Cross-functional Coordination, Global Market Strategy (EU, USA, China)
Preferred skills
Master's degree in Human Factors Engineering, Psychology, or Engineering, Experience with IVD, Fluent English (verbal & written), Experience with diverse user groups
Technologies
IEC 62366, FDA guidelines, MDR regulations, SCRUM framework
Responsibilities
Plan, moderate, and evaluate user tests (internal and external); Analyze usability of instructions and user interactions to prevent misuse; Create complete usability documentation per regulatory requirements; Represent user voice in requirements definition, product/risk analysis, and design decisions; Coordinate internal and external partners; Prepare device approvals for global markets
Seniority
Senior, hands-on IC
