Sean Coyle

Sean Coyle Email and Phone Number

Associate Director, Operations, Medical Device and Combination Product (MDCP) Lead @ Merck
Pennington, NJ, US
Sean Coyle's Location
Pennington, New Jersey, United States, United States
About Sean Coyle

A resourceful Innovation Leader with over a decade of experience in Medical Device development. An expert problem solver with effective audit skills, excelling in leading global cross-functional teams and delivering results across 10 different medical device landscapes including Class I and Class II medical devices (engineered and formulated), combination products, wellness products, and mobile applications. Adept at identifying and solving complex problems, asking the right questions, and bringing together the right resources to find effective solutions. A passionate innovator and inventor, with a creative mind and a drive to translate customer needs into actionable technology. Listed as an inventor on nine patent publications (seven pending). A proven leader with a track record of fostering collaborative environments, mentoring and developing talent, and shaping organizational processes, while consistently ensuring product quality and safety. I thrive in a team that values making a difference in the lives of its customers. I enjoy working in teams with diverse perspectives and backgrounds, learning new skills, and coming together to work on challenging problems and innovative ideas.

Sean Coyle's Current Company Details
Merck

Merck

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Associate Director, Operations, Medical Device and Combination Product (MDCP) Lead
Pennington, NJ, US
Sean Coyle Work Experience Details
  • Merck
    Associate Director, Operations, Medical Device And Combination Product (Mdcp) Lead
    Merck
    Pennington, Nj, Us
  • Kenvue
    Principal Engineer, Future Of Self Care, R&D
    Kenvue Jan 2023 - Present
    Skillman, New Jersey, Us
    • Managing Upstream Innovation projects for SmartCheck™ Digital Ear Scope as Cross Functional Platform Lead. Providing technical leadership for upstream strategy, including acquisitions. Managing internal & external partnerships and providing front and back-room audit support. Leading by influence to develop commercial, Payer and B2B strategies. Secured first B2B contract to distribute SmartCheck™ via Blue Shield of California – Virtual Blue vitals kit. • Spearheading national launch for SmartCheck™, redesigning device and app to increase phone compatibility by 200%. Leading all technical workstreams, change controls and CAPAs. Launching ahead of schedule with minimal resources.• Performing market research and leveraging consumer insights to drive innovation strategy for global Self Care. Breaking down silos and identifying cross-need state synergies to optimize R&D investments & maximize returns. • Founding the Skillman and Summit WHQ Device Development Labs, recruiting, managing and developing multidisciplinary engineering team. Implementing GxP processes to ensure compliance and safety. • Leading Design Controls, IEC 62366 Human Factors and ISO 14971 Risk Management workstreams for Upstream Innovation and serving as a subject matter expert in Medical Device Design Verification & Validation workstreams. • Balancing $2MM budget for Upstream device projects, proactively identifying and resolving budgetary discrepancies.
  • Johnson & Johnson
    Principal Engineer, Future Of Self Care, R&D
    Johnson & Johnson Sep 2021 - Dec 2022
    New Brunswick, Nj, Us
    • Awarded 2022 Johnson Medal for SmartCheck™ from the Children’s TYLENOL, recognizing outstanding innovation and product development at J&J.• Proactively worked with my team to develop talent and foster a culture of internal growth. Ensured each member of the team is put in a position to succeed. Connected with each team member regularly, and conducted regular check ins to understand their professional and personal goals. Set up development planning sessions to track their career development together. • Created an onboarding packet for onboarding new engineers to FOSC, including best practices, important training, and key partners/contacts.
  • Johnson & Johnson
    Senior Engineer / Design Control Lead, Future Of Self Care (Fosc), Self Care R&D
    Johnson & Johnson Jun 2020 - Sep 2021
    New Brunswick, Nj, Us
    • Developing and maintaining design history files for consumer electronic devices and ensure compliance with FDA Design Controls.• Spearheading biosensor & wearables initiative to target chronic disease management.• Lead the Engineering (Optical, Mechanical and Electrical) development, design control, and external partnership management for Project WHO Pilot Launch. Maintained strong relationships both internally and externally, and kept the team focused on calmly and deliberately solving each problem. Created a sense of ownership and dedication for each team member to develop a high quality, safe product for consumers, all while working remotely during a pandemic.• Forged strategic partnerships with new suppliers, enhancing innovation and business development capabilities, and providing Consumer with reliable resources for timely issue resolution.
  • Johnson & Johnson
    Senior Engineer, Skin Health Life Cycle Management
    Johnson & Johnson Apr 2018 - Jun 2020
    New Brunswick, Nj, Us
    • Headed projects life cycle management projects across four different combination product & device portfolios for Johnson & Johnson Consumer, including BAND-AID® Brand, Rogaine®, Bengay®, and Neutrogena®. • Oversaw global life cycle management activities for $20MM Neutrogena Acne Mask™ and Acne Spot Treatment™ portfolio across North America, Europe, and Asia. Prevented supply disruptions due to global chip shortage.• Safeguarded North American supply chain for $50MM BAND-AID® Gauze business and prevented potential revenue loss with timely execution of manufacturing site relocation, completing process validation ahead of schedule.
  • Bd
    R&D Engineer Ii, Vascular Access Mgmt., R&D
    Bd Mar 2016 - Mar 2018
    Franklin Lakes, New Jersey, Us
    • Authored Technical Justifications for material changes in BD PosiFlush™ Externally Sterile (XS) Saline Flush Syringes, achieving annual cost savings of $200,000. • Successfully defended Technical Justifications to regulatory bodies including NSAI, GMED and FDA.• Lead R&D activities to implement the first PosiFlush™ SP manufacturing lines at the BD Fraga manufacturing site. Managed Design History File, reviewed process validation, and prepared technical rationales to release lines ahead of schedule. • Leveraged Design for Six Sigma & Measurement System Analyses to challenge & enhance supplier particulate inspection system. Trained suppliers’ inspectors to catch defective parts prior to shipment to BD.• Awarded patent for peripheral IV disinfecting Connector Cap with Safety Vent (US11389636 B2)
  • Bd
    Research And Development Test Engineer
    Bd Mar 2014 - Mar 2016
    Franklin Lakes, New Jersey, Us
    • Developed fluid path sterility test methods for BD Libertas™ Wearable Injector. Created system of volume control spacers to help deliver exact drug dose to users. • Identified improvements in original BD PhaSeal™ system burst pressure test methods. • Developed a new test method to better evaluate product performance after simulated use.• Co-invented designs for innovative healthcare devices to more efficiently diagnose blood stream infections and leverage machine-readable technology to reduce hospital errors. (Invention disclosures submitted to BD)• Coordinated and executed the proof of concept studies for the innovative healthcare devices.• Oversaw Test Method transfers from the R&D center to the manufacturing plant for BD Simplist™ Prefilled Injectable Line of Products.
  • Smok Signals Llc
    Co-Founder, Tech Lead (Startup)
    Smok Signals Llc May 2012 - Jul 2014
    • Designed, evaluated, and patented VEINUS, Doppler Ultrasound method for locating peripheral veins with high accuracy. (US8764663B2)• Developed intellectual property strategies, including patent filings, to protect valuable innovations• Enabled relationships with investors and subject matter experts to promote business development.
  • Columbia University
    Staff Associate - Ultrasound And Elasticity Imaging Lab – Dr. Konofagou
    Columbia University May 2013 - Dec 2013
    New York, Ny, Us
    • Developed and implemented MATLAB programs to compile and analyze data for Pulse Wave Imaging studies, contributing to research on non-invasive imaging techniques.• Collaborated closely with research team members to understand project requirements and translate them into efficient and effective MATLAB code.• Worked closely with other lab members to troubleshoot technical issues, ensure data integrity, and maintain equipment functionality.• Participated in lab meetings and research discussions, actively sharing insights and suggestions for improving research methodologies.
  • Stevens Institute Of Technology
    Student Researcher - Multifunctional Tissue Formation Lab – Dr. Wang
    Stevens Institute Of Technology Sep 2011 - May 2012
    Hoboken, Nj, Us
    - Performed electro-spinning to create experimental scaffolds for embryonic stem cell research.- Stained and cultured cells for experiments in tissue repair.
  • Mindray
    R&D Systems Engineering Co-Op
    Mindray May 2011 - Aug 2011
    Shenzhen, Guangdong, Cn
    • Coordinated software verification tests for V-series patient monitoring systems.• Managed quality assurance tests on wireless communication system of V-series products.
  • Bd
    R&D Lab Technician Co-Op, Preanalytical Systems
    Bd Jan 2010 - Aug 2010
    Franklin Lakes, New Jersey, Us
    • Analyzed product shelf life and performance of BD Blood Collection sets vs. competitors, and briefed marketing team on the results.• Designed innovative device to reduce pushback failure in blood collection sets (BD Invention Disclosure). • Upgraded and fabricated test fixtures to improve failure analysis of blood collection products.
  • Wytech Industries
    Quality Co-Op
    Wytech Industries Jan 2009 - Aug 2009
    • Investigated the repeatability of wire forming machines to meet specified tolerances.• Redesigned wire forming heads to improve the quality of a wire forming machines.

Sean Coyle Education Details

  • Stevens Institute Of Technology
    Stevens Institute Of Technology
    Biomedical/Medical Engineering
  • Stevens Institute Of Technology
    Stevens Institute Of Technology
    Electrical Engineering

Frequently Asked Questions about Sean Coyle

What company does Sean Coyle work for?

Sean Coyle works for Merck

What is Sean Coyle's role at the current company?

Sean Coyle's current role is Associate Director, Operations, Medical Device and Combination Product (MDCP) Lead.

What schools did Sean Coyle attend?

Sean Coyle attended Stevens Institute Of Technology, Stevens Institute Of Technology.

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