(Senior) Expert Global System Application Engineering

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