Responsibilities:

As 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
* Research of clinical related context
* Design
* 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
* Good technical writing skills in both English and Chinese
* 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.)