"Conquering cancer through AI"
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.
Requirements
🎯 Qualifications
- 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.
🏅 Preferred Experiences
- 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.
📝 How to Apply
🏃♀️ Hiring Process
- 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 Conditions and Environment
- Work type: Full Time
- Work Location : Lunit HQ (5F, 374, Gangnam-daero, Gangnam-gu, Seoul)
- Salary: After Negotiation
🎸 ETC
- 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.
Benefits
🌻 Benefits & Perks
- 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.
