(Senior) Expert Global System Application Engineering
Fresenius Medical Care · Suzhou
The Expert Global System Application Engineering: Enabled the human-centered development with whole life-cycle management to ensure that users complete clinical tasks with FMC products effectively, efficiently, satisfactorily and safely.
Major Responsibilities:
1. Human-Centered Design of hemodialysis related products
Ensure a human-centered system perspective by considering interactions between users, machines, disposables, digital systems, and clinical environments.
- Conduct user research activities, including context analysis, workflow evaluation, etc.
- Define and manage user requirements and related product/system/user interface requirements, with task analysis.
- Support design with concept & solution, provide review feedback with insights
2. Clinical Application & Hemodialysis Expertise
Act as the internal expert for clinical application knowledge and hemodialysis product usage.
- Provide clinical insights throughout product innovation, development, launch, and lifecycle management.
- Support understanding of:
- Clinical users and environments
- Hemodialysis workflows and use scenarios
- Product application, compatibility, and competitive landscape.
- Identify user-related risks and opportunities and provide recommendations for product improvement.
3. System Application & Cross-Functional Collaboration
Execute human-centered design (HCD) activities throughout the product development lifecycle, including planning, implementation, documentation, verification, and validation.
- Act as the interface between different development teams, clinical experts, market organizations, and external users.
- Participate actively in cross-functional teams to achieve project goals, provide regular project updates and communicate HFE-related progress.
- Support development teams with user requirements definitions, system context descriptions, workflow & task analysis, and application concepts.
- Organize & support HFE activities, including usability evaluations (formative and summative studies), and ensure required HFE deliverables are completed according to project milestones.
4. Product Lifecycle Management & Post-Market Support
Support product lifecycle activities from development through post-market surveillance (PMS).
- Provide application knowledge and product use experience to training teams to support product introduction and lifecycle maintenance.
- Monitor user feedback and market observations after product launch and support continuous product improvement.
- Support Quality Management and Product Centers through:
- Quality meetings
- Product issue investigations and task forces
- Market feedback analysis
- Third-level application support
- Ensure compliance with applicable regulations, standards, and internal procedures (e.g., MDR).
5. Usability Laboratory
- Organize simulated dialysis clinic environments according to regulatory and safety requirements.
- Maintain usability laboratory environments for usability evaluations and other activities, ensure availability and operational readiness of:
- Hemodialysis machines
- Consumables and accessories
- Digital systems
- Usability testing equipment (e.g., video systems).
- Coordinate laboratory access, maintenance activities, and improvement measures.
Key Responsibilities Summary
- Integrate clinical application knowledge and user needs into product development.
- Ensure usability, safety, regulatory compliance, and system compatibility throughout the product lifecycle.
- Promote continuous human-center innovation with product improvement through clinical insights and user feedbacks.
Qualifications:
Education & professional experience:
Bachelor and above degree of clinical related with 4+ year experience as healthcare professionals in dialysis center, such as: Nephrologists / Certified renal nurse / Technicians with experience in hemodialysis center operations and quality management.
OR
Master in technical related degrees with 4+ year experience in renal replacement therapy with detailed application knowledge of dialysis center with demonstrated experience of
- Research of dialysis clinical related context, workflow and process analysis with best practices
- Provide medical device design requirements from application perspective with design solutions
- Hemodialysis user research & tests
as following roles in hemodialysis field:
- Marketing/product specialist
- Clinician (e.g. nephrologist, hemodialysis nurse)
- Application trainer
- System Engineer/requirement responsible role
- Product English technical writer
- Usability/human factors engineer
- UI/UX designers or developers
- Other related roles
Competencies
Expertise in dialysis related products and application knowledge of dialysis clinics, ICU, CRRT, home dialysis
e.g. HD machines, all related disposables, water treatment system and Medical IT systems
- Demonstrated professional experience in the dialysis of medical technology application and dialysis clinic quality management.
- Professional experience in design and development of medical devices, user experience& user interface design, validation or requirement engineering, usability engineering, would be an advantage.
Languages:
- (Must) Good technical writing skills in both English and Chinese
- (Must) Fluent spoken Mandarins & English
- (Nice to have) Other languages e.g. German
Important personal qualities:
- High ability to work in a team and to cooperate.
- Excellent communication skills and networked thinking
- Strong commitment and the ability to work independently.
- Structured, quality and result oriented way of working.
- Good at multi-tasks handling and time management skills
IT skills:
- Work daily with MS Office Apps, such as Word, Excel, PowerPoint, Outlook, Teams, etc.
- Familiar of electronic data management
- (Nice to have) design tool: Adobe XD, Axture, Figma
Others
- Willingness to travel occasionally (international and domestic)
- Flexible working time (cross time zone meetings)
- Intercultural competence
- Dealing with different partner functions, organizational affiliations and hierarchical levels