
· Maintains lab areas in a state of audit readiness, following cGMP practices. Assists with metrology requirements for equipment calibration and OOT assessments.
· Performs basic EMC/Safety assessments for design changes to existing product, providing design recommendations to R&D engineers and management. Regularly communicates directly with UL/EU Notified Body on design changes
· Working knowledge of test set up and execution as required per UL/CSA/IEC 61010-1 and 61010-2-101 and other 61010 particulars as applicable. Provides guidance to test technicians and junior engineers on Product Safety test setup, execution and troubleshooting.
· Creates/updates IEC 60825-1 and CDRH laser reports according to Form FDA 3632.