Clinical Validation Specialist

Philips • Suzhou, Anhui, China

5 天前

职位描述

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

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

资格认证

具备以下专业执业资格之一

工作经验

专业能力

语言能力

软技能

其他要求

Required Experience:

Employment Type : Full-Time
Experience: years
Vacancy: 1