Hardikkumar Jayantibhai Lathiya
Senior Process Development Engineer at Medtronic
Galway, Ireland
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I am a senior New Product Introduction (NPI) manufacturing engineer at Medtronic, with extensive experience in advanced process development, scale-up, and manufacturing optimization for medical devices. I specialize in complex drug coating technologies by using ultrasonic spray coating processes in drug-device combination products.
With a strong background in process development and industrialization, I have led multiple initiatives aimed at enhancing manufacturing yield, throughput, and line capacity in regulated, high-volume medical device environments.
I am ASQ (American Society for Quality) certified Six Sigma Green Belt and have a proven track record of applying data-driven methodologies, statistical analysis, and continuous improvement principles to increase yield by 9%. My technical expertise spans process characterization, DOE, equipment validation, and cross-functional collaboration across engineering, quality, and operations teams.
With more than 4 years of international experience in the USA and Ireland medical device industry, I bring a global perspective shaped by experience working across international manufacturing organizations. I am passionate about knowledge sharing and advancing best practices in medical device manufacturing, particularly in the areas of spray coating technologies, process robustness, and NPI execution.
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Hardikkumar Jayantibhai Lathiya
Senior Process Development Engineer at Medtronic
Galway, Ireland
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