
Senior Human Factors & Usability Specialist
루닛(Lunit)<h2>직무</h2><p>Senior Human Factors & Usability Specialist</p><h2>포지션 상세</h2><p>Lunit, a portmanteau of ‘Learning unit,’ is a medical AI software company devoted to providing AI-powered total cancer care.<br>Our AI solutions help discover cancer and predict cancer treatment outcomes, achieving timely and individually-tailored cancer treatment.<br><br>[About the Team & Position]<br>• 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.<br><br>• 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.<br><br>• 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.</p><h2>주요업무</h2><p>1. Human Factors Strategy & Planning<br>• Define and lead human factors engineering strategy across multiple regulated software products (SaMD).<br>• Contribute to usability planning at concept, development, and validation stages.<br>• Ensure activities align with IEC 62366, FDA HFE guidance, and international regulations.<br><br>2. Usability Testing & Research Execution<br>• Design and conduct formative and summative usability evaluations with clinical users (e.g., radiologists, technologists).<br>• Develop research protocols, moderator guides, and participant recruitment strategies.<br>• Analyze qualitative/quantitative data to identify usability risks and design improvement opportunities.<br><br>3. Documentation & Risk Management<br>• Own usability engineering files and documentation for regulatory submissions, audits, and design history files.<br>• Collaborate with risk management to integrate usability-related hazards into FMEAs and risk controls.<br>• Create traceability between user needs, design inputs, and usability outcomes.<br><br>4. Cross-Functional Enablement<br>• Partner with product design and development teams to ensure usability is embedded in every design iteration.<br>• Work closely with RA/QA teams to align testing strategies with submission timelines.<br>• Serve as internal subject matter expert on usability engineering and standards</p><h2>자격요건</h2><p>• 5+ years of experience in human factors engineering, usability testing, or UX research -preferably in medical devices, digital health, or regulated software.<br>• Demonstrated understanding of IEC 62366, FDA human factors guidance, and usability documentation requirements.<br>• Experience conducting usability studies across formative and summative phases.<br>• Strong analytical, research, and writing skills for producing regulatory-grade documentation.<br>• Fluent English proficiency, including technical writing and cross-functional communication.<br>• Bachelor’s or Master’s degree in Human Factors, Cognitive Psychology, Biomedical Engineering, Industrial Design, HCI, or a related field.</p><h2>우대사항</h2><p>• Experience supporting 510(k) or international SaMD regulatory submissions.<br>• Familiarity with cancer screening, radiology workflows, or imaging software.<br>• Working knowledge of risk management standards (ISO 14971) and design controls.<br>• Prior experience with DICOM viewers, EHR/PACS integrations, or clinical workflow tools.<br>• Certification in usability or HFE (e.g., CHFP, CUXP) is a plus.</p><h2>혜택 및 복지</h2><p>• The office is at a very convenient location, just a minute away from Gangnam Station Exit 3.<br>• Meal Allowance is provided (up to 12,000 KRW per meal) when working at the office.<br>• Up to 300,000 KRW is covered upon joining to decorate your personal workspace.<br>• Latest computer models, such as Macs and 4K monitors are provided and can be renewed every three years.<br>• Seminar registration fees and book purchases are covered.<br>• Regular in-house AI and medical seminars are held.<br>• Korean lessons are provided for Lunitians who do not speak Korean as their first language.<br>• In-house English lessons (aka Luniversal) is provided for English development.<br>• Access to high-quality AI learning resources & deep learning DevOps system.<br>• Up to 1.2 million KRW worth of benefits points can be claimed annually.<br>• Holiday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and Chuseok.<br>• Congratulatory and Condolence allowances, along with paid time off are provided.<br>• Annual medical checkups and employee accident insurance are provided.<br>• Expenses for monthly employees gatherings are partially covered.</p>