Responsibilities: As Engineer or Senior Engineer of Program Application Management / Human Factors Engineering, responsible for Usability Engineering of dialysis and other medical systems (e.g. CRRT, ECMO, HD, etc.), including active and non-active products, according to the Global Product Development Process. 1. Conduct usability engineering related research and analysis with documented results · User and use environment · Post-market analysis of similar products on the market of use in terms of Usability engineering · Context and workflow analysis, providing customer and user requirements 2. Support concept and design from usability engineering perspective · Consult about the detail use context · Conduct task analysis providing user interface design requirements · Review and consult about UI design and application terms · Support risk analysis from usability engineering perspective 3. Organize, conduct and document formative and summative evaluations · Plan formative and summative evaluations according to projects’ schedule · Prepare the evaluations with plan documented, recruiting, test tools, environment etc. · Conduct formative and summative evaluations · Analysis and document the evaluation results 4. Organize and consult with usability engineering related documents required by authorities
Qualifications: 1. Required training and education · Master’s degree, prefer in Human Factors Engineering, Cognitive/Experimental Psychology, Human-computer interaction, Industrial Design, biomedical, Electronic, Mechanical, etc. Or other equivalent technical degree, with sufficient trainings in Usability Engineering of medical devices · Good Knowledge of international regulatory and normative standards of medical devices related to usability engineering and user interfaces of medical devices e.g. IEC 62366-1/2, ISO 14971, NMPA usability engineering guidance. · Basic knowledge of Project development process of medical devices, preferred with best practices 2. Professional experience · 3+ years’ working experience of usability engineering in medical device industry with demonstrated experience of o Research of clinical related context o Design o Usability tests with script design, moderating, result analysis etc. Or with demonstrated experience and ability above with hemodialysis related products’ as other roles: English technical writer, Marketing specialist, Clinician (hemodialysis nurse), Application trainer, UI Designs or developers, etc · Experience with acute dialysis application and related products, e.g.: HD systems, CRRT system, ECOM system · Strong analytical skills and design thinking with demonstrate experience 3. Languages · Must o Good technical writing skills in both English and Chinese o Fluent spoken Mandarin & English · Nice to have: German 4. Important personal qualities · Demonstrative ability to learn quickly, work independently, sense of ownership · Good communication and presentation skills, team worker with Intercultural experience · Multi-tasks handling, good planning, organization, and time management skills · Willingness to international and domestic travel occasionally, flexible working time (meetings cross time zone) 5. IT skills · Work daily with MS Office tools, familiar with Word, Excel, PowerPoint, Outlook, Teams, etc. · Cameras, video and audio editing · UI/UX design/prototyping tools (e.g.: XD, Axure, Illustrator, etc.)