岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Responsible as internal point of reference to guaranty bioMerieux active instruments transfer project for localization, to provide technical support and /or improvement to existing products/processes, and lead to setup instruments assembly/testing procedures, validation , and internal/external testing for supporting local registration .  

主要职责 / MAIN ACCOUNTABILITIES

• Lead to setup localized active instrument production capability including tools/fixtures identification , manage start crew training, assembly and testing SOP/Procedures creation for local instruments production, etc;
• Lead local Instrument assembly & testing process validation and product validation including protocol/report writing, validation/study execution guidance etc ; 
• Coordinate internal/external resource and work with third party to accomplish instrument type testing or self-testing, investigate and coordinate to fix any failures during testing ;
• Technology assessment and risk analysis for instrument localization project ;
• Support RA to initiate and accomplish product registration dossiers preparation;
• Participate in Project Meeting to present reports and the status of the work package he/she is responsible for;
• Coordinate parallel projects involving other departments and assure effective communication;

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

• BS or MS major in Electrical and Electronic Engineering/ Mechanical Engineering, > 5 years’ experience in medical active instrument development or manufacturing;
• Knowledge of process and product validation /verification for medical instrument;
• Knowledge of Risk Analysis, Problem Solving, cGMP, Analytical skills;
• Know about Medical Instrument type testing contents (IEC,EMC, Software, Cybersecurity, Environment test, etc ) and regulatory requirement 
• If background involves knowledge of Packing or Filling process will be nice