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MISSION

You will support the Verification and Validation testing activities for the remediation of technical files to the Medical Device Regulation (MDR).

MAIN RESPONSIBILITIES

• Definition of protocols, writing of reports, definition of worst cases
• Implement and maintain system processes and SOPs for Regulatory Compliance related activities
• Developing test plans, protocols and test reports for design verification & validation (V&V) of instruments to be remediated to MDR.
• Definition and documentation of worst-case instruments for different tests.
• Analysis of literature and other documentation for establishing rationales to complete product documentation.
• Coordination of testing with external and internal laboratories
   
   

PROFILE

• Bachelor's or Master's degree in Mechanical engineer/Materials Scientist (HES/UNI) or equivalent
• 1-2 years of industrial experience, medical industry preferred
• Strong skills with MS Office pack, advanced skills with Excel
• Good analytical skills
• Good technical writing skills
• Precise method of working
• Detail-orientation
• Good communication skills in French and English (C1); German would be a plus