Design Assurance Lab Engineer - Medical Devices

DA Lab Engineer - Medical Devices Work Instructions, Mechanical Testing Lab SOP/WI • Execution of product/prototype testing in mechanical testing lab as per the laid down SOP/WI, Protocols. • Execution of assigned product Testing. • Preparing specimens and samples. • Preparing the test equipment setup. • Understanding of the Standard Operating Procedure/Work Instruction, test Protocols/Reports. • Operate and maintain test equipment as per the requirements. • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; maintaining supplies; performing preventive maintenance; calling for repairs. • Perform equipment qualification activities (IQ, OQ, PQ) • Perform equipment maintenance activities in DA lab, as applicable. • Perform equipment calibration activities in DA lab, as applicable, and review calibration results provided by external vendors. • Record, interpret, analyze & compile data and sometimes interpreting results to present to senior colleagues. • Preparing the equipment’s work instructions / SOPs. • Participate in root cause investigation exercise. • Following and ensuring strict safety procedures and safety checks. • Plan experiments and coordinate trials in internal and external labs. • Assist project teams in establishing specifications and quality standards. • Enhances laboratory and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. • Maintain the GLP, GDP and 5S in the lab. • Carrying out other routine tasks as assigned by the supervisor.