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

• 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.

• 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

• 5+ years of experience in human factors engineering, usability testing, or UX research -preferably in medical devices, digital health, or regulated software.
• Demonstrated understanding of IEC 62366, FDA human factors guidance, and usability documentation requirements.
• Experience conducting usability studies across formative and summative phases.
• Strong analytical, research, and writing skills for producing regulatory-grade documentation.
• Fluent English proficiency, including technical writing and cross-functional communication.
• Bachelor’s or Master’s degree in Human Factors, Cognitive Psychology, Biomedical Engineering, Industrial Design, HCI, or a related field.

• Experience supporting 510(k) or international SaMD regulatory submissions.
• Familiarity with cancer screening, radiology workflows, or imaging software.
• Working knowledge of risk management standards (ISO 14971) and design controls.
• Prior experience with DICOM viewers, EHR/PACS integrations, or clinical workflow tools.
• Certification in usability or HFE (e.g., CHFP, CUXP) is a plus.

• Resume (free format)

• Document Screening → Phone Screening → Stakeholder Interview (In-person) → Culture-fit Interview → Onboarding

• After the final interview, we may proceed with reference checks if needed.

• Work type: Full Time
• Work Location : Lunit HQ (5F, 374, Gangnam-daero, Gangnam-gu, Seoul)
• Salary: After Negotiation

• If you misrepresent your experience or education or provide false or fraudulent information in or with your application, it may be grounds for cancellation of the employment.
• Lunit is committed in providing the preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related laws and regulations.

• The office is at a very convenient location, just a minute away from Gangnam Station Exit 3.
• Meal Allowance is provided (up to 12,000 KRW per meal) when working at the office.
• Up to 300,000 KRW is covered upon joining to decorate your personal workspace.
• Latest computer models, such as Macs and 4K monitors are provided and can be renewed every three years.
• Seminar registration fees and book purchases are covered.
• Regular in-house AI and medical seminars are held.
• Korean lessons are provided for Lunitians who do not speak Korean as their first language.
• In-house English lessons (aka Luniversal) is provided for English development.
• Access to high-quality AI learning resources & deep learning DevOps system.
• Up to 1.2 million KRW worth of benefits points can be claimed annually.
• Holiday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and Chuseok.
• Congratulatory and Condolence allowances, along with paid time off are provided.
• Annual medical checkups and employee accident insurance are provided.
• Expenses for monthly employees gatherings are partially covered.

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