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.
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Conduct user research activities, including context analysis, workflow evaluation, etc.
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Define and manage user requirements and related product/system/user interface requirements, with task analysis.
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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.
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Provide clinical insights throughout product innovation, development, launch, and lifecycle management.
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Support understanding of:
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Clinical users and environments
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Hemodialysis workflows and use scenarios
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Product application, compatibility, and competitive landscape.
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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.
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Act as the interface between different development teams, clinical experts, market organizations, and external users.
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Participate actively in cross-functional teams to achieve project goals, provide regular project updates and communicate HFE-related progress.
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Support development teams with user requirements definitions, system context descriptions, workflow & task analysis, and application concepts.
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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).
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Provide application knowledge and product use experience to training teams to support product introduction and lifecycle maintenance.
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Monitor user feedback and market observations after product launch and support continuous product improvement.
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Support Quality Management and Product Centers through:
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Product issue investigations and task forces
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Third-level application support
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Ensure compliance with applicable regulations, standards, and internal procedures (e.g., MDR).
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Organize simulated dialysis clinic environments according to regulatory and safety requirements.
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Maintain usability laboratory environments for usability evaluations and other activities, ensure availability and operational readiness of:
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Consumables and accessories
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Usability testing equipment (e.g., video systems).
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Coordinate laboratory access, maintenance activities, and improvement measures.
Key Responsibilities Summary
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Integrate clinical application knowledge and user needs into product development.
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Ensure usability, safety, regulatory compliance, and system compatibility throughout the product lifecycle.
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Promote continuous human-center innovation with product improvement through clinical insights and user feedbacks.