 Medical Device – Experienced in 21 CFR 820, ISO 13485, IEC 60601, ISO 10993, ISO 14971, ISO 11135, cGMP and other regulations Leadership – Proactive and perseverant self-starter who enjoys the challenges of supporting multiple projects while meeting time and budget goals  Management – 7 years directing and mentoring 10 engineers in cross-functional teams Engineering – Analytical, pragmatic, hands-on approach to product design with a keen interest in the details of engineering and problem solving Manufacturing¬ processes – Milling, turning, EDM, plastics, silicones, extrusion, MIM, sheet metal, laser welding, ultrasonic welding and additional fabricating and joining processes