Engineer, Program Application Management / Human Factors

About The Role

Job Responsibilities

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.
Secondary tasks:

N/A

Miscellaneous tasks:

N/A

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

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
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
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
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.)