Led four member team for successful submission of two EU MDR compliance documents in line with regulatory standards. Ensured safety compliance and corporate satisfaction by resolving mechanical issues. Produced over 30 compliance reports and introduced new test methods in line with industry standards. Evaluated proposed modifications by performing tests for data-driven design changes.
• Examined and revamped medical device components for optimal functionality, incorporating fixture design and conducting validation testing.
• Generated $100M+ annual sales in the EU by remediating capital devices.
• Headed project development from concept to commercialization within defined scope, while maintaining quality.
• Created MATLAB program for high-speed biopsy product analysis that enhanced overall efficiency in product development pipeline.