R&D and Operations Management and lead Mechanical Engineering resource for a medical device company developing a novel non-invasive vascular access surveillance device.

Led team to develop next generation device from Concept, Prototyping, R&D all the way through Design Freeze, Certification and Production.

• Hands on Prototyping
• Setup Development Laboratory Facility (ISO 13485 Compliant)
• Design-For-Manufacturing
• Design Transfer to Manufacturing
• Set up and Maintain In-house Manufacturing Line
• Create and Maintain Design History File (DHF)
• Maintain Device Master Records (DMR)
• Audit Support (ISO 13485)