Sean Coyle

Sean Coyle is a seasoned professional in the medical device and combination products sector with extensive experience in new product development, life cycle management, and risk management. Currently serving as Associate Director, Operations, MDCP Lead at Merck since April 2025, Sean has previously held significant roles at Kenvue and Johnson & Johnson, focusing on compliance with FDA and CE regulatory requirements for Class I and II devices. Sean's background includes coordination of product development for telemedicine devices and life cycle management of skin health products, along with engineering positions at BD, where projects involved Class II and III devices. As a co-founder and tech lead at Smok Signals LLC, Sean was instrumental in developing innovative solutions for healthcare professionals. Sean holds a Master of Engineering in Electrical Engineering and a Bachelor of Engineering in Biomedical/Medical Engineering from Stevens Institute of Technology.