Visionix China

EMC & Performance Test Technician

Posted On February 14, 2022
Accountable For
  • Conducting EMI/EMC and Performance testing of ophthalmology equipment in accordance with test request and work instruction. Oversee new products testing in official lab testing centers and coordinate between regulatory agencies and headquarter. Advise peers and management on matters related to EMI/EMC testing and regulatory compliance in China for ophthalmic equipment. Advise on subjects such as premarket regulatory requirements, import and labeling requirements, or clinical study compliance issues. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Principal Duties:
  1. Test.
    • Configure prototype and production units for testing, as required by the test standard, work instructions, and test request.
    • Perform
    • Document
    • Assist Regulatory Engineers in testing of
    • Provide status and progress of assigned product registration projects.
    • Contact Regulatory Consultant (CRO) and Headquarter Engineer immediately upon failure of a compliance
    • Maintain test files for Regulatory Compliance Test Laboratories in accordance with Chinese standard.
  2. Calibrate / Maintain:
    • Maintain records of all products in testing process and assure the condition and all the equipment used throughout the registration process
    • Assist Lab Engineer with test equipment calibration documentation in accordance to the Quality System (monitoring equipment calibration due dates, records, calibration certificates, maintenance records, ).
  • Associate’s or bachelor’s degree or equivalent, preferably in a technical
  • 2-5 years of hands-on electronics compliance testing, preferably in EMI/EMC.
  • Working knowledge of ISO requirements.
  • Ophthalmology equipment and/or regulatory experience in China and Europe is a plus.
  • Experience in working with international companies operating in China
  • Fluent in English – advantage

Please contact: Yair Govrin Wechat: 18200881164