Providing electromechanical Engineering and establishing document control & Quality Management System framework for a diabetes treatment device integrating insulin and glucagon delivery with continuous glucose monitoring, the Pancreum Genesis.

Directing Research, Product Development, Sustaining & Quality Engineering, Technology Transfer, and technical Business Process initiatives within INFICON's LDT Business Unit• Aligned Engineering and R&D resources on several concurrent complex projects involving cross functional resources, contractors, and satellite production and sourcing in China and Germany• Implemented a New Product Introduction process to maintain seamless alignment of Engineering, Marketing, Manufacturing, Logistics, Sourcing, and Executive stakeholders at product launch• Established a comprehensive Engineering Program Plan defining the departmental scope, operational and quality strategy, and overall program governance

Program Manager defining roles and responsibilities for Engineering, Manufacturing, Quality, International Compliance, Product Management, Marketing, Supply Chain, and Sales for New Product Development, Manufacturing Engineering Operations, and Business Process initiatives for Shark and Ninja International Product Line• Managed domestic and international direct reports for the execution of typically 12+ concurrent New Product Development, Sustaining, and Quality Projects across 4 product categories at several China Manufacturing sites• Harmonized International and Domestic Product Development process, improving on-time delivery of new International products from 50% to 95% - scope included FDA, Electrical design compliance with International regulations, Industrial Design iterations, and consumer 5-Star Quality rating • Developed and implemented a cross-functional business process for Product Configuration Extensions, reducing completion time by up to 50% and improving on-time delivery by 30%

Lead Engineer and Project Manager for International Manufacturing program, coordinating cross-functional teams in US and China to develop and validate manufacturing facilities and production lines for the FDA approved, disposable V-Go Insulin Delivery System• Lean manufacturing• Six-sigma• 5s• Quality Management Systems• Coaching best practices for ISO 9001, ISO 13485, cGMP environment• Facility / ISO 7 (Class 10,000) Cleanroom Validation • Plastic mold validations• Process improvement• Preventative maintenance policies & procedures• Production routers - templates, policies for GDP• Inspection equipment software development and validation• Manufacturing and Quality Assurance procedures, training records• Product Final Test / Non-destructive testing (NDT)• Internal / external audit

Ownership of components and systems across Design Engineering, Quality, and Manufacturing Operations for the high production volume, miniature electromechanical fluid pump, the FDA approved and award winning OmniPod Insulin Management System• Shape Memory Alloy (SMA) Wire expertise• Electroplated plastic-to-PCBA interface• Inventor on 2 patents• Injection molded part design• PCBA / SMT• Design for Manufacture (DFM) / Design for Assembly (DFA)• Product qualification, FMEA, pFMEA• Lean Manufacturing• Automated / Semi-Automated equipment• Assembly and Inspection Process Validation (DOE, IQ, OQ, PQ, PPAP, Gage R&R)• Assembly and Inspection SOP's, work instructions, training• CAD (ProE Wildfire, AutoCAD, SolidWorks)

Designed and improved specialized medical device instrumentation, fixtures, and manufacturing processes for minimally invasive spine surgery• Root Cause Analysis• Electromechanical design revision - eliminating a safety hazard that had caused 20% field rejects• SPC charting• AutoCAD, SolidWorks

Designed custom vibration isolators for HVAC industry per technical requirements and building regulations, structural calculations approved by registered PE• Eliminated field installation errors by implementing a document change and materials management system to harmonize customer submittals with manufactured product