Job Description
STEM Recruitment Partners are working with a medical device company based in Dublin that is seeking 2 x Senior Human Factors Engineers for their R&D operations. The idea behind these roles are to lead human factors and usability validation for medical device products. This role involves collaborating with cross-functional teams to ensure products meet user needs and regulatory requirements throughout the product lifecycle, in compliance with ISO62366, ISO14971, ISO13485, and FDA guidance on human factors. Key Responsibilities: Lead and participate in human factors studies, including formative and summative evaluations. Gather insights into user groups, environments, and needs to inform product design. Plan and execute usability validation studies, defining risk-based acceptance criteria and managing sample size justifications. Ensure compliance with US/EU regulations and medical industry standards for human factors. Collaborate with internal stakeholders and manage external vendors for validation services. Document and communicate usability findings, ensuring alignment with product development. Qualifications: MS/PhD in Biomedical Engineering or related field, with 5+ years in medical device human factors validation. Experience working with end users, preferably in a hospital or clinical setting. Strong knowledge of ISO standards and FDA guidance on usability. Excellent communication skills and attention to detail. Hands-on experience in usability testing and risk management. Hourly rate: €70-90/hour DOE. Skills: Human Factors Usability Medical Devices