Summary
Engineer will be involved in evaluating and testing medical electrical devices according to regulatory standards.
Job FunctionsEvaluation and testing of medical electrical devices to current standards (IEC 60601-1 and IEC 60601-2-x) and implement new standards as needed. Work with clients to set up customer-specific test plans and modify as needed.Assessing quality management systems according to ISO 13485 and performing risk assessments according to ISO 14971.Assists with compliance test setup and troubleshootingCoordinate with laboratory technicians and/or assistants on sample receiving, logging, pretreatment, preparation, testing and other tasks.Routine operation, maintenance, calibration, qualification, and troubleshooting of laboratory equipment and instruments.