Responsible for Operations, Quality, Regulatory, Project Management, and New Product Development Programs

Mission Statement: We provide navigation technology to reduce radiation exposure and improve accuracy. We champion innovation for patients and caregivers alike to create a world where healthcare is safer and more accessible.• Responsible for Quality & Regulatory functions including FDA compliance and ISO 13485 certification process including the creation of quality processes, forms, and work instructions to ensure all products meet regulation requirements • Led executive team through strategy session to develop action based goals and key performance indicators for successful with one and three year initiatives and milestones• Established Request for Proposal (RFP) process and responsible for leading new product development and line extension projects through completion to manufacturing transfer• Created ground up supply chain procedures and processes to support launch of revolutionary new to world vascular surgery imaging and navigation system• Established supply chain for both consumable and capital medical devices including quality, manufacturing, and business assessments of suppliers• Facilitated mission and vision statement exercise with executive team to create compelling statements to support company culture• Navigated multiple complexities and hurdles to support aggressive timelines for clinical trials and ensure product availability

• Own full COGS for all supply chain and manufacturing operations, 340+ employees: engineering, quality, maintenance, EHS, warehousing, plastic injection molding operations, distribution, multi-site manufacturing facilities• Accepted into OSHA VPP Program for both Manufacturing Sites for exceptional safety program; 70% reduction in annual incident rates• Accepted into FDA Case for Quality pilot program; maintained First Pass Yield >99.4% for past 3 years• Led both plants through Brownfield Lean transformation resulting in improvements in all areas of Safety, Quality, Delivery, Cost and Morale• Added 13% annual volume to plant each year while maintaining 99%+ on time delivery; signature product growth at 45% with no customer delays• Insourced major product family: addition of 21,000 hours to annual plan and $450K in annual savings• Led manufacturing initiatives: annual cost reductions of $500K - $1M while supporting double digit growth, numerous new product introductions, and integration of acquisitions• Initiated training programs and efficiency improvements: productivity improvement from 85% to 94%• Successfully integrated 4 acquisitions into Operations including insourcing major product lines while improving cost position and maintaining 99%+ on time delivery to customers• Managed $2M Annual Capital Plan to add capacity and improve facilities to support growth• Trained in Shingijutsu Lean Manufacturing in Japan and participated in Japan Tour of Top Lean Manufacturing companies with Shingijutsu group (Toyota Production System)• Strong working knowledge of FDA & ISO 13485 Quality Systems and participated in all site audits

• Managed multiple departments, 20 employees: Process Engineering, Tool Room, Facilities and Maintenance, Injection Molding and New Product Manufacturing • Operations lead for integration of division’s first acquisition• Worked closely with Continuous Improvement office to implement Lean methodologies including holding 20+ Kaizen events in 2015, implementing standard work, visual management, value streams, and one-piece flow con-versions• Led department continuous improvement initiatives resulted in $1M annual cost savings• Oversaw operations capital planning, make vs. buy analysis, and product standard setting

• Managed Process Engineering Department with direct reporting responsibilities for 5 engineers along with man-aging New Product Manufacturing Department: production supervisor and 4 technicians• Led annual engineering cost saving projects resulting in $400K savings each year• Led engineering activities required to relocate manufacturing to new facility in 2011 while maintaining first pass yield of 99%+ and Customer on time delivery of 99%+• Process Engineering Department focused on supporting all production needs during consistent annual double-digit growth, implementing Lean Manufacturing and automation, and developing manufacturing processes for 6-8 new product launches annually• Interim Production Manager for department of 85 Direct Labor technicians for 6 months• Process Validation Subject Matter Expert; wrote company Quality Systems Procedure for Process Validation in-cluding introducing new forms and tools necessary to perform IQ/OQ/PQ activities• Launched successful company co-op program which led to multiple full time hires across 3 different departments

• Supported manufacturing production needs with 15 - 30% annual sales growth while cutting operating costs, maintaining equipment, enhancing product quality, improving operator ergonomics, and maintaining compliance with ISO 13485 policy• Implemented first robotic automation cell in company history which won the Founder’s Innovation Award• Implemented Lean practices to increase throughput, improve operator efficiency and create visual management• Established and maintained injection mold equipment capacity planning report used to determine new equipment purchase requirements

Analysis Engineer, 2003 – 2005• Responsible for field support of worldwide military PW-F100 engines installed in F-15’s and F-16’s and military PW-F119 engines installed in F-22’s• Analyzed field fault data to establish root cause and recommend troubleshooting path to customer• Collected and analyzed engine field performance data to determine engine health• Completed 100+ hours of F100 and F119 engine familiarization and operability coursesManufacturing Engineer, 2000 – 2003• Developed and maintained various manufacturing processes used in the machining and processing of military and commercial turbine airfoil blades and components• Completed 200+ hours of manufacturing and industry training as part of Pratt & Whitney's elite Manufacturing Engineering Development program• Performed Taguchi Design of Experiments to determine optimal wire EDM cycle parameters to decrease cycle time of bottleneck operation in a one-piece flow cell