director, engineering & regulatory specialist
Mark Cartellone
Mark's versatile product knowledge and creative program & mechanical engineering management skills resulted from extensive experience in product development, project management, manufacturing operations and quality systems management.

His extensive expertise stems from more than 30 years in engineering product development, coordinating & developing numerous offshore products while directing & sourcing manufacturing projects. Mark is an expert in tooling design, injection molded design, stampings and castings. As SmartShape’s Regulatory Specialist, he applies that expertise in product design and development for electronics in both plastic parts and medical devices, making him an integral part of our dynamic team.

In addition to his product design experience, Mark has extensive experience in the development of FDA medical device quality systems (QMS), and, as a specialist in design controls, CE MDD and product design regulatory process and procedures.

Mark has built up regulatory experience in quality systems and medical device design with nearly 20 years participating in 510K's, certified auditing, FDA QSIT audits and other necessary compliance critical within regulated industries such as healthcare.

Specific to the healthcare industry, Mark has more than five years of experience with home medical equipment provider Invacare, where he successfully directed the activities of multiple cross-functional teams to develop four or more power wheelchairs each year, and oversaw the development of disruptive and innovative performance improvements to Invacare's product line.

Mark earned his BSME from Cleveland State University, his A.A.S. Mechanical Engineering from Hocking Technical College, is the recipient of multiple certifications and awards, is affiliated with the American Society of Test Methods and Society of Plastics Engineers and holds more than 30 patents.
Let's Connect
Mark Cartellone
Director, Engineering & Regulatory
+1 216 241 4200 x 233