Sean Coyle Email & Phone Number

Pennington, Nj, Us

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.

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.

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.

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.

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)

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.

• 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.

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.

Hoboken, Nj, Us

- Performed electro-spinning to create experimental scaffolds for embryonic stem cell research.- Stained and cultured cells for experiments in tissue repair.

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.

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.

• Investigated the repeatability of wire forming machines to meet specified tolerances.• Redesigned wire forming heads to improve the quality of a wire forming machines.

Bachelor Of Engineering (B.E.), Biomedical/Medical Engineering

Master Of Engineering (M.Eng.), Electrical Engineering