Mary Parisi is the principal consultant and owner of MedDev Consulting LLC.  She has worked in the medical device industry for over 25 years in the following roles:

• Product Development Engineering and Management in R&D, process development, and quality

• Project Manager and Project Leader for product development projects, business improvement projects, and business alliance management

• Departmental leadership (manager and director roles) in product development, project management, and quality.

• Internal corporate consultant providing input to strategy, contract terms, and corporate procedures and execution of due diligence, project planning and execution, and acquisition integration of equity investments and acquisition of products, technologies, or companies

• Quality Management Leadership in quality engineering (R&D and Operations), supplier quality, complaint handling, calibration, and quality system remediation

• Product Development Leadership as R&D Engineering Director, and Director of Product Development / Core Team Leadership

• Instructor and Researcher

• Consultant providing project management, product development guidance, engineering and quality leadership, and organizational improvement services

Mary's medical device industry experience has been primarily in Class II and Class III, 510k and PMA, implantable and disposable devices and combination products (drug/device), as well as experience with in vitro diagnostics equipment.  Product therapy areas include cardiovascular diagnostics and intervention, orthopedic joint replacement, cosmetic breast reconstruction, urology, oncology, and drug delivery for a variety of medical therapies.  She also has experience in pharmaceutical product development and clinical operations, helping to improve business practices and project management.

Her product development engineering and leadership experience includes project proposals and portfolio strategy as well as project planning and execution of concept through commercialization stages, including clinical studies.  

Mary holds Bachelor of Science degrees in Chemistry (with Biochemistry emphasis) and Physics, as well as a Master of Science degree in Nuclear and Energy Engineering (with core emphasis on mechanical and environmental engineering).   She is a certified Project Management Professional (PMP, through PMI) and Six Sigma Black Belt.

Additional consulting resources can be made available as needed.