- Phone: 716 228 0465
- Cell: 716 228 0465
Specialties & Experience
General Specialties: Medical Devices and Biomedical Engineering
Specialty Focus: Craniomaxillofacial/ Cranioplastic Implants, Medical Devices Regulations & Standards: 21 CFR 820, ISO 13485, FDA QMS & Design Controls, FDA 510k & CE Mark clearance, Risk Management, Pediatric Mandibular Distraction, Distraction Technology, Biomaterials, Bioresorbles, Hydrogels
Education: B.S. Aerospace Engineering, SUNY at Buffalo; M.S. Mechanical Engineering (specialty Biomaterials), SUNY at Buffalo; Dr. Eng. Biomedical Engineering, Cleveland Clinic Foundation- Cleveland State University
Years in Practice: 8+
As a biomaterials and medical device product development expert with 8 years plus of experience, I have developed pediatric Craniomaxillofacial implants from concept to global commercialization in Fortune 500 medical firm. I have successfully developed, FDA-CE Mark cleared, and launched Distraction, Bioresorbable, and Bone Cement technologies. I am the author of several published scientific articles in hyaluronan and collagen hydrogel biomaterials for cartilage and spine repair, and conference speaker in the same fields. I am the inventor of 2 patents in: pediatric mandibular distraction and bioresorbable polymer plating, respectively. I have led the entire product development process from concept, design, development, verification and validation testing, production and commercialization. My strong research background provides me with extensive experience and enhanced ability to analyze scientific data and identify strengths and weaknesses in both scientific methods and data. I am an achiever, influential, creative problem solver who can contribute to strategic thinking and approach in legal cases. I conducted my doctoral research in Biomaterials at the renowned Cleveland Clinic Foundation, and I am the recipient of the Innovation Patent Award 2017 at medical firm. I have degrees in Aerospace Engineering B.S., Mechanical Engineering M.S., and Biomedical Engineering Dr. Eng.