-Managed a technical team of scientists, quality engineers and process engineers to design and develop innovative medical devices for the US and global markets.-Served as a project manager for medical device projects to lead strong collaboration between cross functional groups including clinical affairs, quality assurance, R&D, marketing and operations.

- Led a technical team responsible for developing and commercializing new wound care products into the manufacturing environment.- Managed product realization from concept through commercialization, working with cross-functional teams to ensure design controls were in place to appropriately address customer requirements and minimize compliance risk.-Oversaw process transfer activities to increase throughput 2-fold while maintaining quality standards.-Executed successful vendor relationship strategies to procure materials and confirm consistent delivery.-Appropriately budgeted and staffed new product development projects to ensure product launch dates were met.-Responsible for strategic identification of new regenerative technologies and business opportunities for distribution and acquisition.-Developed wound reconstruction platforms and collaborated cross-functionally with leadership to identify the products to pursue through the business funnel.

-Performed quality due diligence activities for potential medical device corporate acquisitions and integrate quality systems following acquisitions to ensure business continuity; reported findings and recommendations to executive leadership for final acquisition decisions.-Developed a quality system integration playbook to address the essential activities for successful integration and to minimize future business disruption.-Worked with cross-functional teams to develop and execute strategies for quality system integration following corporate acquisitions.-Worked with private label partners to maintain strong relationships as it pertains to quality.-Led the quality management system work-stream to ensure processes are updated for EU Medical Device Regulation (MDR) compliance.-Prepared manufacturing sites for external audits and provided front room and back room audit support during FDA, AATB, and notified body audits.

-Managed a team of quality engineers supporting new product development and sustaining operation activities of human tissue products. -Executed health hazard evaluations and risk assessments to ensure the safety of MTF tissue products and medical devices.-Executed sterilization validations, product and package stability studies, and biocompatibility assessments.

-Served as a project manager ensuring the planning, procuring and development of medical device components for a timely release of quality products to the customers. -Designed and executed validations of processes used to manufacture medical device components.-Performed risk assessments including FMEAs to prevent potential process failures during production.-Knowledgeable on FDA and ISO requirements for product development-Developed and validated mechanical tests to ensure product quality prior to product release.-Performed customer complaint investigations with a cross functional team and executed root cause analysis. -Composed and reviewed documentation for regulatory and quality requirements.

-Served as a research scientist for Marodyne Medical LLC in conjunction with the postdoctoral fellowship. -Designed pain management clinical trials using Marodyne’s technology, per FDA requirements, to accelerate regulatory approval and product commercialization into the medical market.-Applied as the Principal Investigator for Small Business Innovation Research (SBIR) Grants through the National Institute of Health in order for Marodyne to obtain funding for R&D expansion.