Job Description :
Mechanical System Engineer with knowledge of Electro mechanical system
Knowledge on Medical device quality management as per ISO 13485, 21CFR820, 21CFR4
Knowledge on risk management as per ISO14971 (Knowledge preparation on risk management plan, DFMEA, PFMEA
Knowledge on Test method validation ( test method development, test fixture preparation, IQ/OQ/PQ, TMV protocol preparation, test execution, final report preparation etc)
Knowledge on good manufacturing practice, good documentation
Experience in Diagnostic equipment’s will be preferred
Exposure to PLM system