Responsibilities:

As Technical Leader or Technical Manager of Program Application Management / Human Factors Engineering, responsible for application management and Usability Engineering of hemodialysis related systems (including active and non-active products), according to the Global Product Development Process.

1. Organize and conduct application and 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 application and usability engineering perspective

• Provide detail use context and use cases with insights of the existing products on the market
• Conduct task analysis, providing user interface design requirements
• Review and consult about UI design and application terms
• Support risk analysis with uFEMA and application perspectives

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 for CE, NMPA etc.

5. Manage the application knowledge transfer by product application trainings

• Definition of product / system specific training content
• Manages and conducts the training and authorization of international Training Centers, clinical and marketing regarding product applications
• Support and consult marketing and sales in specific product knowledge for customer communication

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.
• Familiar with Project development process of medical devices with best practices

2. Required professional experience

• 5+ years’ working experience of usability engineering in medical device industry with demonstrated experience of:
  • Research of clinical related context
  • Provide Design requirements from application perspective with design solutions
  • Usability tests with script design, moderating, result analysis etc.
  • Usability test plan, 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.
• 5+ years’ working experience of hemodialysis related products with in-depth knowledge
• 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.)