Shawn Horner Email & Phone Number

- J&Js Flagship MESE1 Smoke Evacuator and Accessories - an efficient smoke capture capital device used during surgery, which has been one of the fastest growing product lines including supporting accessories- J&J's ACE/GEM Precision cutting blades, which allows surgeons to use electricity to cut in place of a scalpel, which is one of the higher GP product lines in the J&J Energy portfolio- Development and launch of many other general purpose electrosurgical pencils, devices for neurosurgery, and more - Certification & Compliance: Led the research, definition, and development of medical hardware, ensuring compliance with UL, CE, BSI, and FDA certifications.- Project Management: Transformed undefined concepts into fully realized projects aligned with company objectives.- UDI Mandate Integration: Managed the integration of FDA’s Unique Device Identification (UDI) mandates (21 CFR 830 and 21 CFR 801.45) into SOPs, labeling, processes, and quality systems.- Cost-saving Initiative: Cultivated a partnership with an OUS manufacturer to replace a bi-polar cable line, saving a multi-million-dollar product family.- Production Process Improvement: Developed a progressive stamping process for the production capability of the ACE Blade product family.- Business Rationales & Viability: Created multiple business rationales based on marketing inputs to assess project viability or determine discontinuation.- Leadership & Efficiency: Recognized for the ability to drive projects efficiently, fostering team learning and growth.OTHER* Inventor on more than 20 patents resulting in successful product offerings to market* Published in various Medical Journals and forums (AORN)* Experience supporting surgeons and accounts at their facilities* Earned "Johnson & Johnson Leadership Award" within first two years of service

- Created fully burdened COGs and capital requirements for two independent projects.- Assisted in the development of six new safety device product lines.- Coordinated with vendors to meet tight timelines for component deliveries.- Developed product designs and initial documentation for patent submissions.- Created presentations for upper management to present to potential clients.

- Create and prototype minimally invasive vascular and non-vascular medical devices.- Lead/managed catheter/implantable port -related projects through product and process development, technical analysis, and integration of emerging technologies. Combined the PASV Valve Technology (Catheter Innovations) with the Vaxcel Catheter technology to create a flagship product family.- Developed/implemented design changes to the PASV Ultem dual port product line to remove micro cracking and cross lumen communication.- Ensure compliance with FDA, CE, and Notified Body standards, design controls, and related documentation.

- Presented formal project reports, proposals and design reviews to senior management- Performed testing and inspection of meniscal repair devices - Developed solid modeling skills