Mike Mirizzi

Background

About Mike Mirizzi

Seasoned R&D executive with hands-on management, technical leadership, business skill, and invention experience taking medical device disposable and capital equipment embedded systems through concept, technology, product development, pre-production and commercialization in start-up, mid-size and large companies spanning multiple clinical indications. Strong leadership skills building successful R&D teams using cross-functional resources.• Demonstrated hands-on technical leadership, engineering skill, inventiveness and management of advanced engineering teams, new product incubation and commercialization activities including front-end creative as well as product development of medical devices• Experienced planning, budgeting and executing projects to develop disposable devices, electromechanical catheters, implants, surgical and embedded system capital equipment for both mainstream US/OUS markets as well as emerging markets• Skill set includes hands-on device and procedure conceptualization, prototyping, hands-on customer interaction, intellectual property management, annual departmental and project budgeting, individual and team management, product detail design, preclinical testing, verification and validation testing, clinical studies, manufacturing transfer and product launch physician training support• Extensive experience in identifying unmet clinical needs, understanding competitive landscape, intellectual property landscape and user needs for new and next generation product• Extensive experience in identifying and developing in-vitro and in-vivo testing models. Organized, led and participated in over 60 animal studies spanning multiple species as well as cadaver models both acute and chronic studies, GLP and non-GLP