Sean Coyle

Background

About Sean Coyle

I am a resourceful medical device development leader and expert problem solver with a proven track record of launching breakthrough medical devices. I have over 15 years of product development & life cycle management experience in the MedTech & BioPharma industry. My core competencies include: Class I, II and medical devices Combination products Connected devices. Medical Device Quality Management - ISO 13485 and FDA QSR Medical Device Risk Management - ISO 14971 Medical Device Usability - IEC 62366 Medical Electrical Equipment - IEC 60601 Prefilled Syringes - ISO 11040 I possess a strong technical foundation that allows me to actively guide cross-functional teams in: Requirement development Device design Test method development Lab Management Design verification and validation Technology transfer Process validation and optimization My technical expertise enables me to seamlessly collaborate with engineering teams, effectively manage technical dependencies, and clearly communicate with both technical and non-technical stakeholders to achieve strategic alignment. I excel at overseeing the planning, execution, and delivery of complex technical projects, meeting aggressive delivery schedules, managing budgets, and complying with all quality & regulatory standards. In my role, I not only focus on project accomplishments but also foster a culture of internal growth within my team. I believe in connecting regularly with each member, understanding their goals, and tracking their career development together. I am committed to fostering a collaborative and patient centric culture that drives successful medical device innovation and technical excellence. I'm available to discuss new opportunities in the NYC, Raleigh-Durham, Philadelphia, Boston, and New Orleans areas or virtual (remote). Please contact me at Sean.James.Coyle@gmail.com. Let's connect if you're ready to revolutionize the world of healthcare technology with innovative solutions that put patients first!