(Seoul) Senior Human Factors & Usability Specialist · Lunit INSIGHT

Lunit, a portmanteau of ‘Learning unit,' is a medical AI software company devoted to providing AI-powered total cancer care. Our AI solutions help discover cancer and predict cancer treatment outcomes, achieving timely and individually-tailored cancer treatment. 🗨️ About the Team & Position We are seeking a Senior Human Factors & Usability Specialist to lead the planning, execution, and documentation of usability and human factors engineering (HFE) activities across our portfolio of AI-powered cancer screening software and platforms. This role plays a critical part in ensuring our products are safe, intuitive, and regulatory-compliant, especially within the context of IEC 62366, FDA guidance, and other international usability standards for medical devices. The ideal candidate brings a strong background in user-centered design research, risk-informed usability testing, and cross-functional collaboration in regulated healthcare product development. You will work closely with product managers, designers, engineers, clinicians, and regulatory teams to embed usability and human factors principles into our development lifecycle - helping us deliver clinically meaningful, easy-to-use products for healthcare providers around the world. 🚩 Roles & Responsibilities Human Factors Strategy & Planning Define and lead human factors engineering strategy across multiple regulated software products (SaMD). Contribute to usability planning at concept, development, and validation stages. Ensure activities align with IEC 62366, FDA HFE guidance, and international regulations. Usability Testing & Research Execution Design and conduct formative and summative usability evaluations with clinical users (e.g., radiologists, technologists). Develop research protocols, moderator guides, and participant recruitment strategies. Analyze qualitative/quantitative data to identify usability risks and design improvement opportunities. Documentation & Risk Management Own usability engineering files and documentation for regulatory submissions, audits, and design history files. Collaborate with risk management to integrate usability-related hazards into FMEAs and risk controls. Create traceability between user needs, design inputs, and usability outcomes. Cross-Functional Enablement Partner with product design and development teams to ensure usability is embedded in every design iteration. Work closely with RA/QA teams to align testing strategies with submission timelines. Serve as internal subject matter expert on usability engineering and standards.