Provide manufacturing support with equipment and manufacturing issues.Execute IQ/OP/PQ for new and existing manufacturing equipment.Design and draw new test fixtures with SolidWorks.Perform manufacturing process audits.Maintain detailed engineering lab notebook.

•Perform disposition, root cause and corrective action on manufacturing non-conformance materials.•Perform various tests in support of process monitoring, design verification, materials qualification, engineering feasibility, and process validation.•Compile quarterly complaints data (Risk Management) for management review.•Use basic statistical tools to analyze data.•Maintain detailed lab notebook.•Work with other departments to acquire test samples or equipment.•Set-up and use standard measurement equipment and gauging equipment.•Perform internal process audits.•Execute complex testing per released test methods.•Perform equipment installation qualification.

•Perform disposition, root cause and corrective action on manufacturing non-conformance materials.•Perform various tests in support of process monitoring, design verification, materials qualification, engineering feasibility, and process validation.•Compile quarterly complaints data (Risk Management) for management review.•Use basic statistical tools to analyze data.•Maintain detailed lab notebook.•Work with other departments to acquire test samples or equipment.•Set-up and use standard measurement equipment and gauging equipment.•Perform internal process audits.•Execute complex testing per released test methods.•Perform equipment installation qualification.

•Perform electrical, mechanical or electromechanical duties and document technical functions relating to test, calibration, repair and modification/upgrade of RF generators used for cardiac catheter ablation.•Perform installation, repair and upgrades on 3-D real time heart mapping systems.•Respond to customer requests for emergency service. Determine cause, troubleshoot and take corrective action.•Execute preventative maintenance programs and maintain performance and service records for equipment.•Repair and re-image PC workstation used with the heart mapping systems.•Active participant in training programs related to new equipment.•Communicate with customers to assure customer satisfaction with regards to equipment repair.•Complete all activities within the Service Management System (Siebel) through daily updates and documentation.

•Perform complex tests of medical RF equipment, formulations, prototypes, processes and product.•Responsible for performing test validation protocols, data tabulation and validation reports.•Qualify and validate new equipment (IQ, OQ, PQ), manufacturing associated processes and new components.•Setup, maintain (PM), repair, calibrate and adjust complex unit test equipment and perform troubleshooting.•Responsible for the creation and maintenance of test procedures and electronic test datasheets for the manufacturing and testing of production medical energy based devices.•Active in identifying and participating in cost reduction programs.•Support Reliability Quality Assurance with customer complaints by way of troubleshooting returned products and providing detailed reports.•Trained in the decontamination process for receiving clinical used medical devices.