Speaker

Hardikkumar Jayantibhai Lathiya

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.

Area of Expertise

  • Manufacturing & Industrial Materials

Topics

  • Medical Device Manufacturing
  • drug coating in medical device
  • ultrasonic spraying
  • Yield improvements
  • Lean Six Sigma
  • six sigma green belt
  • DMAIC
  • Solidworks
  • Statistical analysis
  • Process Development
  • process improvent
  • Process Optimization
  • Manufacturing & Production
  • Quality Engineering
  • R&D
  • New product development

Hardikkumar Jayantibhai Lathiya

Senior Process Development Engineer at Medtronic

Galway, Ireland

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