Hands-on product development / quality professional with broad based experience in R&D, Software Engineering, Project Management, Quality Management and Regulatory Affairs. Successful track record developing and launching highly complex products and systems in the medical device,medical diagnostics, biotechnology and telecommunications industries. Thorough knowledge of business needs, technology trends, and the regulatory environment. Leads and develops highly effective cross functional teams that produce outstanding results.Mike has demonstrated his expertise leading the product development process for some of the world’s best known companies. At Novartis he leads an innovative effort to reduce development time and costs via consolidation of the company's multiple product architectures. At Abbott, he directed R&D, and all software development activities for an extended portfolio of diagnostic and surgical systems used in ophthalmology. His strategic vision and organizational talents have guided his cross-functional teams through the successful launch of numerous new and improved products to the global market. He demonstrated his drive for innovation through the application and grant of multiple patents. At Bayer and Becton Dickinson, he introduced streamlined development processes and automated development tools, substantially improving time to market, customer satisfaction and regulatory compliance. His strengths stem from deep understanding in the areas of software engineering, project management, process improvement and quality management. He is a change agent, effectively introducing improved design control processes. His expertise includes process validation, validation plans and test protocols. He is a sought out liaison within the business, successfully bridging the communication gaps between the business, technology and regulatory perspectives. .Mike attended Pace University, graduating Magna Cum Laude in Computer Science.Specialties: Medical Device Development | Systems Engineering | Software Development | Quality Management | Project Management | Process Improvement | Opthalmic Surgery | Medical Diagnostics | Hematology | Immunochemistry | Configuration Management | Requiremen|s Management | Validation & Verification | Command & Control Systems | Real-time Embedded SW Development | Firmware | SEI-CMMI | ISO 13485 | ISO 62304 | FDA-GMP