Board Member providing quality, manufacturing, and logistics leadership for startup action sports company.

Site Lead post Relign acquisition - Grew annual sales from $1.2M to $12M over three years, remotely oversaw 13 production lines, and 26 employees based in California, Ohio, and China. Led Integration Team to align startup procedures and documentation with new corporate systems and requirements while expanding production lines from 1,000 to 35,000 devices over three years.

Developed thirteen orthopedic product lines in a startup environment from initial concept to commercial launch - including an RF controller, RF/mechanical shaver handpiece, nine disposable shavers/RF probes, and two tubing sets. Activities included initial 510k testing and submission, production line(s) IQ/OQ/PQ validation, device and user verification and validation, biocompatibility, transit, shelf life, cleaning and sterilization validations. Operated an efficient and flexible Quality Management System per FDA CFR 21 and EU MDD/MDR in a heavily-regulated environment without any major notified body findings or adverse events.

Assisted with product design transfer and new product development activities post-acquisition. Performed sales support by traveling with sales force to train surgeons and initiate product sales.

Lead international engineering team for 510k testing and De Novo 510k submission for Fluid Management Accessories (FMA) as part of a uterine fibroid resection system. Created overseas manufacturing line, including incoming inspections, fixturing, end of line test equipment, work instructions, routers, and quality documents, including line transfer from Hungary to Costa Rica.