StellenbeschreibungÜberblickReporting to the Sr. Director of Global Human Factors Usability Engineering, the Staff Engineer (based in Cressier - Switzerland) will lead Human Factors Engineering (HFE) activities and design validation for IVD medical devices, ensuring user-centered design, safety, and regulatory compliance.How You’ll Make an ImpactLead and execute human factors engineering activities throughout the product development lifecycle, from concept to post-market, for various IVD/medical devices.Conduct user research, including contextual inquiry and formative usability testing, to identify user needs, mental models, and pain points.Translate user research findings into clear and actionable design requirements and specifications.Created detailed task analyses, including the perception, cognition, and action model.Evaluated designs against industry standard usability heuristics.Develop and execute comprehensive design and human factors validation plans and protocols, including summative usability testing, to demonstrate the safety and effectiveness of medical devices for intended users and use environments.Analyze and interpret data from usability studies, identifying critical user interface issues, risks, and opportunities for improvement.Prepare detailed human factors reports, design validation reports, and other technical documentation for internal stakeholders and regulatory submissions (e.g., FDA, EU MDR, IVDR).Collaborate cross-functionally with RD, Marketing, Quality, Regulatory Affairs, and Clinical teams to integrate HFE principles into product design and development.Provide expert guidance to project teams on human factors best practices and regulatory requirements.Participate in risk management activities, including use-related risk analysis, uFMEA, and contribute to the development of mitigation strategies.Stay current with industry best practices, regulatory guidance (e.g., IEC 62366-1, AAMI HE75), and emerging technologies in human factors and medical device development.What You BringBachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, or a related field. Master's degree preferred.7+ years of experience in human factors engineering and design validation within the medical device industry.Strong understanding of IVD/medical device regulations and standards related to human factors (e.g., FDA Human Factors Guidance, IEC 62366-1, AAMI HE75).Proven experience in planning, executing, and reporting on formative and summative usability studies.Demonstrated ability to translate user research into user needs, design requirements, and specifications.Excellent analytical, problem-solving, and critical thinking skills.Strong written and verbal communication skills, with the ability to effectively present technical information to diverse audiences.Proficiency with usability testing tools and software.What We OfferCompetitive salaryCompany restaurantAnnual bonus salary reviewHybrid working model (3 days on site and 2 days home office)Employee Referral schemeContribution to fitness subscriptionEmployee assistance programmeTraining Development programs, with access to LinkedIn Learning. #J-18808-Ljbffr
