• Performed Operational Qualification (OQ) and Performance Qualification (PQ) on different processes of the ePTFE tubular vascular prosthesis manufacturing and also planned and executed different engineering studies for process improvements • Used Minitab for statistical analysis of study data in accordance with FDA quality system regulation• Prepared and released engineering documents in Product Lifestyle Management Systems (Agile)• Executed Pilot Production Builds (PSO) for OQs… Show more • Performed Operational Qualification (OQ) and Performance Qualification (PQ) on different processes of the ePTFE tubular vascular prosthesis manufacturing and also planned and executed different engineering studies for process improvements • Used Minitab for statistical analysis of study data in accordance with FDA quality system regulation• Prepared and released engineering documents in Product Lifestyle Management Systems (Agile)• Executed Pilot Production Builds (PSO) for OQs, PQs, and Engineering Studies• Hands on testing experience: Suture Retention Test (SRT), Water Entry Pressure (WEP), Longitudinal Tensile Strength (LTS), and Radial Tensile Strength (RTS) using Instron machines.• Learned the importance of traceability and maintaining good documentation practice (GDP) Show less

• Took an operator course on the basic functions of Engel Injection Molding Machines including both theory and practice at Engel India Machine Test Centre• Visited customer sites to observe new machine installations and/or service visits

• Worked under the quality control engineer at the firm• Operated an Engel Injection Molding Machine.• Operated and maintained a Branson Ultrasonic Welding Machine• Learned about different business processes and solutions to overcome industry challenges