Craig Tolmie

Development and sustaining engineering of a Class 2 medical drug delivery device for Inhaled Nitric Oxide therapy. Responsible for primary research for technology selection for next generation gas delivery. System architect for next generation Nitric Oxide gas delivery system, intellectual property and business growth protection. Responsible for managing standards certification: 60601-1-2 and IEC60601-1 EMC directive. Lead investigator on several problem root cause investigations and provided defect resolution for electronics, sensors & electro-mechanical hardware & embedded device software. SME during FDA site visits while following CAPA process. Development of hardware specification, prototyping, construction and test methods

Product Development of life support and drug delivery medical devices systems for Critical and anesthesia care areas. Design electrical hardware for analog and digital embedded systems. Electro-mechanical systems hardware packaging design for manufacturability, serviceability and test. Component and system level certification for IEC601-1-1EMC and electrical safety directives. Defect root cause diagnosis and resolution for electronics, sensors and electro-mechanical hardware. Hardware prototyping construction and testing.