Shanghai, CHN
22 days ago
Usability Engineer
**Usability Engineer** At Philips Image Guided Therapy (IGT) we transform the delivery of minimally invasive procedures through intelligent, connected imaging and clinical workflow solutions. Within the iApps organization, we design and develop advanced clinical applications that provide real-time guidance, decision support, and workflow automation to clinicians worldwide. The intuitive use of these applications is critical for ensuring procedure efficiency, clinical confidence, and patient safety. To strengthen our organization and meet the evolving NMPA usability requirements, we are looking for a Usability Engineer to join our team in Shanghai, China. You will serve as the local usability representative for the iApps product portfolio, working in close collaboration with your Azurion usability counterpart in Shanghai, and partnering with global teams in the Netherlands and India. **Role summary** As a Usability Engineer in the iApps organization, you ensure that our software applications and integrated workflows are safe, effective, intuitive, and compliant with usability regulations. You are an advocate for user-centered design and clinical workflow excellence, working closely with UI/UX designers, clinical scientists, product managers, systems engineers, and software development teams. You will guide the usability engineering process end-to-end for China-market submissions, contributing directly to the design of high-impact software that clinicians rely on during interventional procedures. Those activities include: + Conduct user research including hospital observations, being the eyes and ears of the usability team in China regarding workflow analysis and insights. Create task analysis and use scenarios. + Analyze post-market data including recalls, adverse events and literature. + Lead multidisciplinary usability FMEA / use-related risk analysis sessions, to identify use-related problems and support the design of safe-to-use user interfaces. + Plan, execute and report usability evaluations in China and ensure critical findings are fixed. + Conduct summative evaluation and create the usability medical device documentation, in compliance with the NMPA guidance (priority), as well as FDA and IEC62366-1 (if needed). **Hiring requirements** **Proven experience and knowledge:** + Minimum 2 years of experience in usability engineering process for medical devices, including usability strategy, usability FMEA, formative and summative evaluations, and writing usability engineering file. + Good knowledge and understanding of regulation requirements for usability of medical devices: NMPA (priority), FDA guidance and IEC62366-1. + Good understanding of quality systems (QMS) and risk management principles. + Good understanding of the healthcare domain and clinical workflow in hospitals. + Preferred: experience in working effectively in multidisciplinary teams and in a complex global company. **Academic background:** + Degree in Human Factors Engineering, Human–Computer Interaction, Cognitive Science, Interaction Design, Biomedical Engineering, or related field. + Master’s degree or PhD preferred. **Skills:** + Independent and proactive, capable of representing the iApps usability function locally in China. + Strong communication, facilitation, and stakeholder management skills. + Ability to advocate effectively for user needs and challenge assumptions in a constructive manner. + Strong analytical and problem-solving skills, including root-cause analysis of use issues. + Ability to produce high-quality formal documentation. + Excellent verbal and written English. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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