Engineer, Program Application Management / Human Factors Engineering

Fresenius Medical Care · Suzhou

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Job Responsibilities

1) Main tasks:

Usability Engineering of dialysis and other medical systems (e.g. CRRT, ECMO, etc.), including active and non-active products according to the Global Product Development Process.

• 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
• Support concept and design from usability engineering perspective
• Provide detail use context and use cases
• Conduct task analysis, providing user interface design requirements
• Review and consult about UI design and application terms
• Support risk analysis with uFMEA 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.
• Support Usability lab in CDC with maintenance work.

2) Secondary tasks:

N/A

3) Miscellaneous tasks:

N/A

Qualifications, experience, know-how and skills critical for success

• 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 degrees, with 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) Required professional experience (in years):

• 3+ years working experience of usability engineering in medical device industry with demonstrated experience of

o Research of clinical related context

o Provide Design requirements from application perspective with design solutions

o Usability tests with script design, moderating, result analysis etc.

o Usability test plan, moderating result analysis etc.

Or with demonstrated experience and ability above, as one of following roles of hemodialysis related products': English technical writer, Marketing specialist, Clinician (hemodialysis nurse), Application trainer, UI Designs or developers, etc.

• Experience with acute dialysis application and related products
• Strong analytical skills and design thinking with demonstrate experience

3) Important personal qualities:

• Demonstrative ability to quick learner, work independently and proactively with strong ownership
• Good communication skills, team worker with Intercultural experience
• Multi-tasks handling, organization, and time management skills

4) Other specialized knowledge:

a) Technical knowledge

• In-depth knowledge about hemodialysis related Medical application
• Basics in Requirement Engineering
• Good Presentation skills
• Good knowledge in Workflow and Process analysis with best practices

b) Languages

• Must

o Good technical writing skills in both English and Chinese

o Fluent spoken Mandarin & English

o Nice to have: German

c) 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.: XO, Axure, Illustrator, etc.)

d) Product knowledge

Fields of application e.g. Dialysis Clinics, ICU, Home Dialysis

• In Center product portfolio & interfaces e.g. RO systems
• CC&V product portfolio & interfaces e.g. CRRT system, ECOM system

5) Special personal requirements:

• Willingness to international and domestic travel occasionally
• Flexible working time cross time zone meetings

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