Job Description

Job Title

Clinical Validation Specialist

Your role:

• 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.

You're fit if:

• 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 validation’s clinical sites，Collects Design Validation Records and feedback from the clinical site and ensures they both adhere to good documentation practices.

Requirements工作要求

• Master’s 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 preferable.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here