Lead for all aspects of product development from proposal to transfer to manufacturing, including FDA submission for multiple projects - Managed $5M development effort over 12 months, including team members, technology, and supply chain, for an upper respiratory molecular diagnostic cartridge, which in 2 months moved from design release to first passing product.- Led development on 5 separate COVID-19 detection products prepared for FDA EUA submission. Identified vendors and designed products for the production of upwards of 100M annual units to accommodate resin and swab shortages.- Within 3 months, enabled the inception of our Project Management Office (PMO) by leading a team of new PMs to develop their technical skills in managing engineers, which allowed our PMO to manage 100% of the projects within our IVD-solutions group.- Within 6 months, mentored a team of novice engineers to develop their technical leadership of programs, QMS documentation, and personal soft skills to independently manage their own engineering teams. This allowed our company to take on 25% more customers and grow our annual sales.

Led initiatives for all aspects of product development, transition to manufacturing, and FDA submission for multiple projects- By successfully meeting project milestones, I drove the company’s growth in brand and positive reputation, expanding our number of repeat customers, and increasing our head count, which all led to double digit year over year growth in annual sales. - Due to the trust my senior leadership had in my abilities to manage customer projects, they were freed up to focus on the growth of our organization and positioned it for a successful acquisition.- Managed separate $4M and $3M projects with the parallel development of a disposable cartridge and instrument. Each project included a team of 15 engineers that achieved concept to fully integrated molecular diagnostic cartridge and instrument prepared for FDA clearance in 24 months. - Led cross-functional teams to develop diagnostic cartridges to detect sepsis, automated blood panel diagnostics, continuous white blood cell separation for gene therapy, cfDNA extraction from plasma, and gene therapy delivery instruments. - Worked closely with the quality team to manage the release of engineering procedure documents for ISO 13485 certification.- Developed strong partnerships with domestic and international suppliers to support the manufacturing of medical diagnostic products. This includes molding companies for injection, micro, LSR, and compression, converters, machine shops, and high-volume assembly equipment. This strong preferred supplier network allowed our company to reduce our prototype development timelines to one month or less for the procurement of all subcomponents for a prototype assembly.

Lead designer and primary customer interface across a variety of medical diagnostic products- Designed products for high-volume assembly from concept to FDA submission including V&V, usability, and stability testing.- Developed domestic and international supplier network for biocompatible foils, films, resins, and sub-component manufacturing. - Designed, molded, and tested multiple cartridges with novel on-board reagent storage methods to optimize shelf-life.

Lead mechanical designer for novel in vitro cancer drug testing prototypes- Designed, built, tested, and assembled the molded body, LSR gaskets, and electrical system for cell incubation and agitation.

Oversaw multiple projects for U.S. Government customers and managed effective engineering teams - Designed, manufactured, tested, maintained, deployed, and recovered Unmanned Underwater Vehicles (UUV) to allow the US Navy to safely test novel sensors developed by private sector contractors. These sensors enabled collection of oceanographic data in remote locations without any personnel present.