Clear-thinking manufacturing operations executive with 40+ years’ experience managing high-tech/high-value product manufacturing lifecycles through rapid introduction, ramp-up to batch and flowline production volumes and their decline. Strong understanding of manufacturing operations principles required for effectively controlling changing product lifecycle challenges in the medical device, aerospace and telecom markets. In-depth knowhow and understanding of ISO13485 QMS for medical devices and the principles that bind together CE marking conformity under the AIMDD and MDD. Implementing systems and structures required for the business, taking responsibility for the necessary leadership, coaching, cross-functional team coordination and resource engagement.Specialties:Resource leadership, High technology product introduction and ramp-up, EU and global medical device regulatory compliance, Quality management for medical devices, Production engineering, Manufacturing process and systems development, Developing working relationships with internal and external resources