Biomedical Engineer with over 10 years of experience in the manufacturing and development of non-active medical devices. Certified Black Belt in Design for Six Sigma, adept at guiding design teams in employing advanced techniques to create high-quality products that exceed customer expectations and prevent the release of defective items into the market. I relish facing new challenges and am dedicated to enhancing process efficiency and effectiveness.I hold myself to high standards and am particularly demanding of my own performance. I enjoy both being an integral part of a team and managing, motivating, and training productive teams. I thrive in high-pressure, challenging environments.Standard: ISO 13485, ISO 14971, EN 62366-1 FDA CFR 21 part 820