• Leader and founder of Project Management Office consisting of Project Management and Labeling Resources for a medical device start-up which went public on the NYSE in 2023• Manager and point of contact for new market launches, supplier contracts, Class III FDA Submission (also involving an In estimation Al Device Exemption clinical study), and product discontinuation projects

• Project Manager for new product design, development, and manufacturing projects• Successful project management and completion with regulatory clearance in the US for new medical device• Attend cadaver labs for engineering trials and design validations• Directing and coordinating production activities to develop products and ensure progress as the product specifications are developed into a technical specification• Leading product and process development projects in a new manufacturing site. • Providing technical leadership, root cause analysis, and resolving customer related problems• Hands-on with new production equipment and product R&D• Attend various medical device conferences to support and visit our customers and vendors

● Project Manager for product development projects that require full validation and 510(k) submissions ● Lead new product development programs for the leading medical device companies in the industry. ● Act as main point of contact to customer during development activities.● Serve as subject matter expert in support of braiding, extrusion, needle attachment and general assembly operations in the performance fibers business unit. ● Facilitate the completion of regulatory strategies, manufacturing qualifications and validations, sterilization evaluations, product labeling and IFUs with project working team.● Manage multiple projects effectively and independently at all levels of product/process development stages. Develop project schedules, lead regular meetings and discussions around project priorities.● Execute Design Control and Documentation activities (Design Reviews and DHFs) for multiple active projects.

● Lead a labeling database overhaul affecting all parts● Involved in design for manufacture troubleshooting for suture based products ● Managed product development projects

● Developed protocols and executed design and process verifications and validations ● Worked with vendor on new equipment to enhance process capabilities● Created and updated technical drawings and 3D parts utilizing SolidWorks and Adobe Illustrator● Enhanced current manufacturing procedures

● Monitored and ensured polycondensation reactions worked at the optimum level and conducted relevant tests and inspections● Worked on a team that led our company to receive the 2008 Frost & Sullivan North American Product Innovation of the Year Award.