Engineer, Program Application Management / Human Factors Engineering

Job Responsibilities 1) Main tasks:Usability Engineering of dialysis and other medical systems (e.g. CRRT, ECMO, etc.), including active and non-active products according to the Global Product Development Process.

• 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
• Support concept and design from usability engineering perspective
• Provide detail use context and use cases
• Conduct task analysis, providing user interface design requirements
• Review and consult about UI design and application terms
• Support risk analysis with uFMEA and application perspectives
• 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
• Organize and consult with usability engineering related documents required by authorities for CE, NMPA etc.
• Support Usability lab in CDC with maintenance work.2) Secondary tasks:N/A3) Miscellaneous tasks:N/AQualifications, experience, know-how and skills critical for success*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 degrees, with 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 practices2) Required professional experience (in years):
• 3+ years working experience of usability engineering in medical device industry with demonstrated experience ofoResearch of clinical related contextoProvide Design requirements from application perspective with design solutionsoUsability tests with script design, moderating, result analysis etc. oUsability test plan, moderating result analysis etc.Or with demonstrated experience and ability above, as one of following roles of hemodialysis related products': English technical writer, Marketing specialist, Clinician (hemodialysis nurse), Application trainer, UI Designs or developers, etc.
• Experience with acute dialysis application and related products
• Strong analytical skills and design thinking with demonstrate experience3) Important personal qualities:
• Demonstrative ability to quick learner, work independently and proactively with strong ownership
• Good communication skills, team worker with Intercultural experience
• Multi-tasks handling, organization, and time management skills4) Other specialized knowledge:a) Technical knowledge
• In-depth knowledge about hemodialysis related Medical application
• Basics in Requirement Engineering
• Good Presentation skills
• Good knowledge in Workflow and Process analysis with best practicesb) Languages
• Must oGood technical writing skills in both English and Chinese oFluent spoken Mandarin & English oNice to have: Germanc) 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.: XO, Axure, Illustrator, etc.)d) Product knowledgeFields of application e.g. Dialysis Clinics, ICU, Home Dialysis
• In Center product portfolio & interfaces e.g. RO systems
• CC&V product portfolio & interfaces e.g. CRRT system, ECOM system5) Special personal requirements:
• Willingness to international and domestic travel occasionally
• Flexible working time cross time zone meetings