Vice President R&D
CurrentResponsible for new product development of Class III smart infusion pump. Hands on project management and systems development using mix of Agile and Waterfall approach.Define short-term objectives and ensure timeliness of deliverables to meet the project goals within budget. Manage engineers in ME, EE, SW, FW, Sys Eng, Manuf. for design/development from concept to V&V.Manage quality assurance and regulatory compliance team members for ISO-13485 and FDA PMA submission preparations—writing SOPs, project plans, test plans, manufacturing plans, test reports, ECOs.Manage external consultants for development and manufacturing design transfer of silicon-based piezo micropump, development of implantable catheters, animal testing of infusion pump prototypes.