Human Factors Engineer - Medical Devices & IVD - MDx CRO
hace 5 días
Santander
Join a mission-driven team advancing the safety, usability, and performance of next-generation in vitro diagnostics. MDx CRO is seeking a highly motivated Human Factors Engineer 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. You 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. If you are passionate about understanding users, improving healthcare technologies, and working collaboratively in a high-growth environment, we would love to speak with you. Your Mission As our Human Factors Engineer, you will: • Lead, document, and scale HF activities 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., • Analyse qualitative and quantitative study data, identify root causes, and generate clear, insightful HF reports., • Deliver user-interface and workflow design recommendations informed by empirical evidence, user feedback, literature reviews, and HF best practices., • Shape HF processes and frameworks, ensuring compliance with the latest HF/usability standards, including FDA, IEC, ISO, AAMI, and relevant regulatory guidances., • Prepare and review HF documentation for regulatory submissions, including interactions with notified bodies and regulatory authorities. Provide clear rationales and expert responses to questions when required., • Collaborate with internal and external stakeholders, contributing HF expertise across design and development documentation, risk management, and product lifecycle activities., • Travel occasionally for user research, client engagement, or usability testing activities. What You Bring • At least 2 years of professional HF/usability engineering experience or equivalent exposure in product development within a regulated environment. Prior experience in IVDs is strongly preferred., • Strong knowledge of qualitative and quantitative research methodologies., • Solid understanding of user-centred design practices and HF integration within product development lifecycles., • Familiarity with FDA, IEC, ISO, AAMI and other applicable HF/usability standards, including regulatory HF expectations., • Experience partnering with IVD manufacturers or operating within diagnostics, medtech, or medical device environments., • Excellent technical writing skills and the ability to communicate complex findings in a clear, compelling way., • A proactive mindset with the ability to learn fast, take ownership, and drive work independently., • Strong interpersonal skills and a genuine passion for understanding users and improving their experience., • Collaborative spirit—comfortable working openly with diverse teams in an iterative environment., • Confident communicator with experience in presenting, interviewing, and facilitating workshops., • Excellent written and spoken English. Bonus Skills (Nice to Have) • Master’s degree in Human Factors / Usability Engineering, Cognitive Psychology, Biomedical Engineering, HCI, Anthropology, or a related field., • Experience developing in vitro diagnostics, SaMD, or digital health solutions., • Hands-on experience with FDA or other regulatory authority interactions, including HF contributions to product submissions or audits.
