Mark Cartellone — Director of Engineering & Regulatory Specialist
Director of Engineering & Regulatory Specialist
Mark Cartellone’s versatile product knowledge, paired with creative program and mechanical engineering management skills, has allowed him to accrue extensive experience in product development, project management, manufacturing operations, and quality systems management.
With more than 30 years of experience in engineering product development, Mark has developed a wide variety of expertise, including deep knowledge in tooling design, injection molding, stampings, castings electronics, plastic product and part design, offshore source and manufacturing, and other various manufacturing methods, which makes him an integral part of our 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.
For more than 16 years, Mark has also built up regulatory experience in quality systems and medical device design, with participation in 510K’s, certified auditing, FDA QSIT audits, and other necessary compliances critical within regulated industries like 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.