Extensive accomplishments in R&D, product development and product manufacturing, developing profitable new in-vivo and in-vitro cardiac assist devices/equipment embodying new technologies and new clinical therapies. Inventor for (30) issued patents (with others pending) for medical devices/equipment used in cardiac care and pharmaceutical delivery. Career experience also includes development of aerospace electro-mechanical and laser-based equipment used in defense and space programs. Experienced in multi-disciplinary team environments both as a senior individual contributor and in management, including management senior staff positions in larger and smaller organizations. Specialties include: 21CFR820 & ISO9000 medical device development, in-vitro and in-vivo pre-clinical study design and testing, CAD/CAM/CAE tools (including selection and implementation), Design of Experiments (DOE), manufacturing equipment and processes (including SPC), CIDM (customer-integrated decision making), and human factors engineering.