Summary of Qualifications Designed and developed several medical devices which serve the areas of ophthalmic, orthopedic, bariatric, thoracic, general and endoscopic sinus surgery. Directed and Managed all aspects of product and process development, regulatory affairs, manufacturing operations, supplier chain, distribution, quality assurance and post market surveillance for Class II and III devices. Develop and maintain relationships with strategic teaching hospitals and surgeons. Lead multiple cross functional product development teams utilizing Five Phase Stage - Gate design reviews. Established and managed Quality Management Systems which lead to ISO 13485 Certification and several FDA audits with no major non-compliances. Authored, submitted and maintained Technical Files for FDA clearance and European approval. Managed all operations of Class II and III manufacturing facilities including clean rooms and automated assembly, processes and packaging equipment. Developed packaging systems for devices to be compatible with ethylene oxide, gamma and steam sterilization processes. Skilled at Solid Works, Minitab, LabView and all Microsoft Professional Office software.

Highlights:

• Complaints
• Failure Analysis
• Manufacturing
• Documentation
• Injection Molding
• Macromedia Flash
• Packaging