(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

1. 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.

1. 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.

1. 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).

1. 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