Job Information
Fresenius Medical Care North America Technical leader, Program Application Management / Human Factors Engineering in Shanghai, China
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.
- 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
- 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
- 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.
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 :
- 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
- 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
- Languages
Must
Good technical writing skills in both English and Chinese
Fluent spoken Mandarin & English
Nice to have: German
- 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)
- 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.)
Fresenius Medical Care North America
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