PbJoin a mission-driven team advancing the safety, usability, and performance of next-generation in vitro diagnostics. /b /ppbr/ppMDx CRO is seeking a highly motivated bHuman Factors Engineer /b to lead and coordinate human factors (HF) and usability engineering activities across our growing portfolio of medical device and IVD development programs. In this role, you will act as the primary HF expert within the organisation, driving user-centred design practices, developing HF / usability engineering files, and planning and executing formative and summative usability studies. /ppYou will also influence upstream and downstream processes—including design documentation, risk management, and regulatory submissions—working closely with internal teams, external partners, and global clients. /ppIf you are passionate about understanding users, improving healthcare technologies, and working collaboratively in a high-growth environment, we would love to speak with you. /ppbr/ppbYour Mission /b /ppAs our Human Factors Engineer, you will: /pullibLead, document, and scale HF activities /b across multiple concurrent medical device, IVD and diagnostic projects in collaboration with cross-functional teams. Activities may include ethnographic research, requirements definition, task analysis, use-related risk analysis (aFMEA/uFMEA), usability studies, and review of market/user feedback. /lilibAnalyse qualitative and quantitative study data /b, identify root causes, and generate clear, insightful HF reports. /lilibDeliver user-interface and workflow design recommendations /b informed by empirical evidence, user feedback, literature reviews, and HF best practices. /lilibShape HF processes and frameworks /b, ensuring compliance with the latest HF/usability standards, including FDA, IEC, ISO, AAMI, and relevant regulatory guidances. /lilibPrepare and review HF documentation /b for regulatory submissions, including interactions with notified bodies and regulatory authorities. Provide clear rationales and expert responses to questions when required. /lilibCollaborate with internal and external stakeholders /b, contributing HF expertise across design and development documentation, risk management, and product lifecycle activities. /lilibTravel occasionally /b for user research, client engagement, or usability testing activities. /li /ulpbr/ppbWhat You Bring /b /pullibAt least 2 years of professional HF/usability engineering experience /b or equivalent exposure in product development within a regulated environment. Prior experience in bIVDs /b is strongly preferred. /liliStrong knowledge of bqualitative and quantitative research methodologies /b. /liliSolid understanding of buser-centred design practices /b and HF integration within product development lifecycles. /liliFamiliarity with bFDA, IEC, ISO, AAMI /b and other applicable HF/usability standards, including regulatory HF expectations. /liliExperience partnering with bIVD manufacturers /b or operating within diagnostics, medtech, or medical device environments. /liliExcellent btechnical writing skills /b and the ability to communicate complex findings in a clear, compelling way. /liliA proactive mindset with the ability to blearn fast, take ownership /b, and drive work independently. /liliStrong interpersonal skills and a genuine passion for bunderstanding users and improving their experience /b. /liliCollaborative spirit—comfortable working openly with diverse teams in an iterative environment. /liliConfident communicator with experience in bpresenting, interviewing /b, and facilitating workshops. /liliExcellent written and spoken English. /li /ulpbr/ppbBonus Skills (Nice to Have) /b /pulliMaster’s degree in bHuman Factors / Usability Engineering /b, bCognitive Psychology /b, bBiomedical Engineering /b, bHCI /b, bAnthropology /b, or a related field. /liliExperience developing bin vitro diagnostics, SaMD /b, or digital health solutions. /liliHands-on experience with bFDA or other regulatory authority interactions /b, including HF contributions to product submissions or audits. /li /ul