Clinical Validation Specialist

Job Title

Job Description

寻找一位具备放射医学或医学影像专业背景拥有10年以上CT临床应用经验及7年以上医院影像诊断经验的资深临床专家能够代表最终用户视角推动CT产品临床验证图像评估及法规合规工作并为研发团队提供专业临床指导

• To test CT systems from an end user perspective by performing the related clinical workflow in a simulated environment or real use environment.

• To prepare the validation related documents in English peer review other design documents and provide timely feedback.

• To provide clinical expert opinion regarding the CT workflow image quality and performance needs to R & D engineer.

• To establish and maintain good relationships with clinical experts hospitals and governments to co-ordinate site visits obtain clinical data and information and organize expert visits.

职位概述

• 从最终用户医生/技师的角度出发在模拟环境或真实临床环境中执行相关临床工作流程对CT系统进行测试和验证

• 负责用英文编写和维护验证相关文档参与其他设计文档的同行评审并及时提供反馈意见

• 为研发团队提供关于CT工作流程图像质量及临床性能需求等方面的专业临床意见

• 建立并维护与临床专家医院及政府机构的良好合作关系协调临床现场访问获取临床数据与信息并组织专家评审活动

Responsibility工作职责

• Responsible for Design Validation Plan Design Validation Protocols and Design Validation Report. Defines the entry and exit criteria for Design Validation.

• To organize and perform internal and external validation activities to validate the clinical satisfaction and acceptability of product and function under clinical circumstances.

• To establish and maintain good relationships with clinical experts hospitals and governments according to PDLM and project requirements therefore to co-ordinate site visits obtain clinical data and information and organize expert visits.

• To join risk analysis for clinical feedback according to Risk Evaluation process.

• Has overall responsibility for the design validation function and outputs overall planning coordination and tracking of the Design Validation activities and act as SME during internal and external Audits.

• Responsible for Design Validation Traceability Matrix generating and providing validation evidence for different regulatory bodies (FDA NMPA CE etc.) as per the company QMS process.

• Has ability to participate in image review and can give observation/feedback independently

• Translate issues reported from the clinical sites into defects. Submit defects in the defect management tool.

• Provides the training and guidance for the design validations clinical sitesCollects Design Validation Records and feedback from the clinical site and ensures they both adhere to good documentation practices.

工作职责

• 负责制定设计验证计划Design Validation Plan设计验证方案Design Validation Protocol和设计验证报告Design Validation Report并定义设计验证的准入和退出标准

• 组织和执行内部及外部验证活动在真实临床场景下验证产品及功能的临床满意度和可接受性

• 根据PDLM流程和项目需求建立并维护与临床专家医院及政府机构的合作关系协调医院现场验证获取临床数据和信息并组织专家评审活动

• 根据风险评估流程Risk Evaluation Process参与临床反馈相关的风险分析工作

• 对设计验证活动及交付物承担总体责任包括验证活动的规划协调和跟踪并在内部及外部审核中担任领域专家SME

• 负责设计验证追溯矩阵Design Validation Traceability Matrix依据公司QMS体系要求为FDANMPACE等监管机构提供验证证据

• 能够参与医学影像评审并独立提出专业观察及反馈意见

• 将临床现场反馈的问题转化为缺陷Defects并在缺陷管理系统中提交和跟踪

• 为临床验证合作医院提供培训和指导收集设计验证记录及反馈确保符合良好文档规范Good Documentation Practices

Requirements

• Masters degree in Radiology/Radiography or higher (with thesis is preferable)

• Has professional certification (Professional License):

• Radiologist or Radiographer

• 7-years imaging diagnosis/imaging analysis experience in hospital

• 10 years of work experience in radiography technology which includes working with CT systems

• Knowledge in imaging product principles. Skills in CT product category are preferable.

• Knowledge and experience in CT photon counting technology is a plus point.

• Knowledge of the progress and trends of imaging products and able to give instruction for product design and update.

• Proficient in both written and spoken English.

• Has soft skills in leading and organizing activities.

• AI skills and usage is preferrable.

教育背景

• 放射医学Radiology或医学影像技术Radiography硕士及以上学历

• 有毕业论文研究经验者优先

资格认证

具备以下专业执业资格之一

• 放射科医师Radiologist

• 医学影像技师Radiographer

工作经验

• 7年以上医院影像诊断或医学影像分析工作经验

• 10年以上医学影像技术相关工作经验其中需包含CT设备使用或相关工作经验

专业能力

• 了解医学影像产品工作原理

• 具备CT产品相关知识和经验者优先

• 了解光子计数CTPhoton Counting CT技术者优先

• 熟悉医学影像行业的发展趋势及技术演进能够对产品设计和升级提供专业指导

• 具备较强的图像质量评估能力和临床工作流程理解能力

• 能够将临床需求转化为产品需求和研发输入

语言能力

• 英语听说读写能力优秀能够独立进行国际化工作沟通和技术文档编写

软技能

• 具备良好的组织协调能力和项目推动能力

• 能够主导并组织跨部门跨医院的验证活动

• 良好的沟通影响力和专家关系管理能力

其他要求

• 具备AI工具应用和使用经验者优先