Expert Global Human Factors Engineering

Introduction section

At Fresenius Medical Care, we are the world's leading provider of products and services for individuals with renal diseases. Guided by our vision-“Creating a future worth living. For patients. Worldwide. Every day.”-we work with purpose and compassion, supported by a global team of over 112,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way- growing with purpose and leading kidney care with integrity and innovation

Information about plant:

At our Changshu plant in China, we manufacture life-sustaining products that support dialysis patients around the world. Our portfolio includes dialyzers, bloodline sets, dialysis solutions, hemodialysis machines, and key medical components. Using advanced technologies such as injection molding, extrusion, and automated assembly, our teams help ensure the highest standards of quality and reliability. Join us and become part of a global team committed to creating a future worth living for patients worldwide.

Job Responsibilities:

Main tasks：

Responsible for Human factors engineering of hemodialysis related products (including active and non-active, Class II/II medical devices) according to the Global Product Development Process.

1. Organize and conduct application and human factors engineering related research and analysis with documented results

• User and use environment of different region in China, AP and globally
• Global post-market analysis of similar products on the market of use in terms of Usability engineering
• Use cases with customer and user requirements based on context and workflow analysis

2. Support concept and design from application and human factors engineering perspective

• Keep connecting with clinical experts, provide detailed use context and use cases
• Conduct task analysis, providing user interface design requirements with insights
• Review and consult about UI design and application terms
• Support risk analysis with uFMEA and application perspectives

3. Organize, conduct and document formative and summative evaluations

• Plan formative and summative evaluations according to projects’ schedule
• Prepare the evaluations with recruiting, test tools, environment, and plan documented.
• Conduct formative and summative evaluations
• Analysis and document the evaluation results

4. Organize and consult with usability engineering related documents required by authorities

• Conduct formative and summative evaluations
• Support global teams

5. Usability Lab maintenance

• Support maintaining the usability lab with all medical devices and disposables according to regulation requirements and guidance (e.g. 6S, EHS, dialysis center)
• Organizing tools (e.g.: video system) for conducting usability assessments.

Qualification for candidate：

1. 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 sufficient training and working experience in Human factors engineering/Usability engineering of medical devices

2. Working experience: 5+ years’ working experience in human factors engineering of medical devices (prefer in renal replacement therapy / extracorporeal therapy products) with demonstrated experience, such as:

· Research of clinical related context

· Design and/or provide design requirements from clinical application

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

· Prepare HFE documents for CE, NMPA, FDA

3. Key professional knowledge with best practices

· 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, FDA HFE guidance, NMPA UE guidance.

· Project development process of medical devices

4. Product and application knowledge: Dialysis fields of application e.g. Dialysis clinics, ICU, Home Dialysis, especially dialysis Center hemodialysis product portfolio & interfaces e.g. HD systems, RO systems, Medical IT Systems

5. Languages

· Good technical writing skills in both English and Chinese, fluent spoken Mandarins & English

· Nice to have: Other languages e.g. German

6. Other important personal qualities:

· Good communication and Presentation skills, team worker with Intercultural experience

· Demonstrative ability to quick learner, work independently and proactively with strong ownership

· Good at multi-tasks handling, organization, and time management skills

· Willingness to international and domestic travel occasionally

· Flexible working time (cross time zone meetings)

7. IT skills:

· Work daily with MS Office tools, familiar with Word, Excel, PowerPoint, Outlook, Teams, etc.

· Cameras, video and audio editing

· Nice to have: UI/UX design/prototyping tools (e.g.: XD, Figma, Axure, Illustrator, etc.)