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Fresenius Medical Care North America Senior Engineer, Program Application Management/Human Factors Engineering in Shanghai, China

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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Languages

  • Must

  • Good technical writing skills in both English and Chinese

  • Fluent spoken Mandarin & English

  • Nice to have: German

  1. 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)

  1. 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.)

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