Oberlin, Ohio, United States
Senior technical leader with extensive experience spanning 40+ years in component-based, multi-site co-development for high-availability medical device (18 years) and military systems (15 years), with expertise in global cross-functional team leadership, strategy development/realization, systems engineering, project management, multi-site process improvement, disciplined software engineering (CMMI), Six Sigma methods (DMAIC/DFSS), design for reliability, FDA Design Controls (QSR), EU (MDD), U.S. Dept. of Defense, and international quality standards (ISO 13485, ISO 14971, IEC 60601, IEC 62304).
40 years of working professionally is enough!
Senior consultant focusing on program and project management and general design controls (software and hardware) skill building for global medical device manufacturers. Expert in software development following IEC-62304, software risk management, and integration of other quality subsystems with design controls. Extensive global experience in leading large scale effort (as program management, lead consultant and design controls domain expert) recreating Design History Files for complex (20+ computing elements) medical devices spanning multiple development sites as a basis for evolving these with new features following IEC-62304. CAPA program manager for medical device manufacturer under consent decree that led to successful completion and full resumption of operations.
Consulting firm leader providing strategy and implementation leadership to medical device clients in support of compliance to design control elements of domestic and international quality standards (FDA QSR, Medical Device Directive (93/42/EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 12207, IEC 62366), reliability objectives, and Lean Six Sigma methods (DMAIC/DFSS).
Responsible for Engineering Quality Assurance, Validation and Infrastructure teams (~45 FTEs). Was key leader in driving remediation of FDA Audit findings related to CT/NM design controls Corrective/Preventive Actions, impacting project management, defect management, verification, validation, hazard management, field monitoring, and adverse event reporting.
Responsible for all building blocks which comprise every finished CT medical device, including Detection, Reconstruction, User Console, Gantry, X-ray Generation, Patient Support, Service and Simulation. In this role I drove the realization of a multi-phase platform strategy with aggressive improvements in cost, performance, reliability and serviceability with each successive generation. My team was responsible for all elements of the business plan for each subsystem, including roadmap/strategy, development, design transfer, supply management, production strategy, release and post-release monitoring. The global team was distributed among Cleveland, Haifa (Israel), Bangalore (India) and Shenyang (China)
Responsible for all CT teams (~110 FTEs) performing system-level devlopment functions organized around Systems Engineering, Physics and Verification/Validation disciplines. As this was during a major transformational change during the Philips “go global” period, I played a key role in integrating duplicate teams across 3 sites (U.S., Israel, India) into global entities with common objectives/mindset/process. I personally drove the Comprehensive Reliability Plan for the flagship/breakthrough iCT/Ovation product, with work package elements for Engineering, Supply Management, Manufacturing and Customer Support. This product demonstrated breakthrough reliability performance relative to earlier platforms.
Proposed concept, developed plan and executed a common, cross-functional product development phase/gate process (LCM) across all Marconi Medical units. Enfranchised stakeholders from all Marconi modalities (e.g. CT, MR, NM, IM), all locations (Cleveland, Israel, Finland, U.K.) and all functions (Project Management, Marketing, Engineering, Operations, Service, Regulatory). The multi-year, multi-phase process improvement plan was recognized by a corporate management award. Was a key contributor in leading reaction to FDA inspection remediation of multiple design controls observations affecting verification and validation, project management, risk management and field monitoring. Utilized by Marconi, plc as Systems Engineering Domain Expert to conduct technical due-diligence of $3B FORE Systems (in Pittsburgh). Invited to conduct additional assessments in the UK, and Italy by Marconi.