Senior Engineer, Program Application Management/Human Factors Engineering

Responsibilities:

AsSenior 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.)