Yesha Katbamna

I am a results-oriented medical device professional with over 14 years of diverse experience in quality systems, process validation, manufacturing engineering, and regulatory compliance. With a strong academic background in biomedical engineering and hands-on expertise in FDA, ISO 13485, ISO 14971, and EU MDR standards, I have successfully led cross-functional teams, developed global validation strategies, and driven continuous improvement initiatives. My career spans both technical execution and leadership roles, including managing engineers and collaborating across R&D, Quality, and Regulatory functions. I am passionate about delivering high-impact, compliant solutions that enhance product quality and support patient safety.

Experienced medical device professional with over 14 years in quality assurance, process validation, manufacturing engineering, and regulatory compliance. Proven track record in leading cross-functional teams, developing global validation strategies, and ensuring adherence to FDA, ISO, and EU MDR standards across the product lifecycle.

San Jose State University, San Jose, California MS, Biomedical Engineering 

C U Shah College of Engineering & Technology, Surendranagar, Gujarat, India BS, Biomedical & Instrumentation Engineering