Achieved 2019-2020 a 15% product cost reduction to bottom-line; Doubled production shipments year-over-year for 3 years running; 2020 Inventory Turns 70. Successful operations leader is responsible for the development and implementation of the DTG production and quality final integration center operation. Lead the rapid transfer of new product designs into production using an agile global supply chain. Direct day-to-day production operations and work process improvement projects across all functions to maximize profit. As the quality management representative ensure the company maintains compliance to ISO 9000 quality management system standards.

Managing customer service, operations and quality management for the Medical Display Repair, Computer Server Equipment Assembly, and Medical Cart Fabrication Work Cells. Responsible for leading implementation of a lean manufacturing 5S system that improves workplace inefficiencies and waste.

Working knowledge and proven experience providing FDA medical device regulatory compliance; ISO 13485 quality system development tools, external and internal audit support, and standard operating procedures to increase customer satisfaction while reducing the Cost of Quality.Quality Control Team Leader responsible for leading process improvement teams in receiving inspection, customer order fulfillment, RMA’s, NCMR’s, and QC inspection of medical surgical instruments at KLS Martin LP. Defined (21) processes, revised SOP’s, created work instructions, & conducted process training improving internal customer satisfaction.Microsoft SharePoint Application Trainer delivering Intelligent content quality process development procedures, work instructions and training on software platform including quality assurance verification testing for IT software application developers at eZassi LLC

Experienced team leader responsible for the development and implementation of the Harmar Quality Management System in accordance with the FDA 21 CFR 820 Quality System Regulations and the ISO13485 Medical Device International Standard. Ensure effective and efficient use of quality techniques such as Pareto analysis, Histograms, and establish product quality plans. Conduct the role of Management Representative creating customer complaint management processes with technical services, Quality CAPA/NCMR/RMA, HR, Production, Purchasing, and Engineering function writing procedures/work instructions in a manufacturing operation. Responsible for internal audit and supplier audit functions.

• Developed business strategies with executive management in a team environment, drafted business plans, conducted intellectual property protection services for inventors as well as entrepreneurs starting two new companies and delivered quality management consulting to healthcare company. Consulting services delivered in the following industries: Plastic Surgery, Musical Instruments, Electronics, Long Boarding Sports, Medical Devices, Aerospace, and IT industries.• Launched healthcare IT consulting firm; manage all operations including business development, contracts, marketing, and P&L.• Negotiated and won engagement to provide physician practice and hospital with improvements in efficiency, data accuracy, patient experience, and care by conducting the abstraction and standardization of patient data into the EMR system. Hands-on experience conducting clinical data abstraction and upload using Allscripts and NextGen EMR systems.• Provided initial training to hired contractors using NextGen EMR software

e-Zassi invented the 1st open innovation software platform designed to provide a secure online environment where representatives from all industry segments can scout and match with innovation(s) without intellectual property risk.• Key member of founding and leadership team that launched breakthrough product in open innovation for the medical device space; established the world’s 1st and only medical device Innovation Assessment and Collaboration engine.• Project managed the invention assessment software patent application for new medical device innovation analyses (IA) platform with a proprietary FDA regulatory assessment and NIH (National Institute of Health) grants modules. Conducted intellectual property (IP) brainstorming sessions, drafted invention disclosure documentation, and drafted extensive patent application & with third party patent law firm.• Leverage databases across universities, medical specialties, product development, companies, VCs/private equity firms, and manufacturers to provide SaaS platform for emerging medical technology inventors, start-ups, and the life science community to source, evaluate, and partner with synergistic technology organizations, investors, and service providers;.• Defined policies, procedures, and processes to support the platform across a variety of medical device segments including Cardiovascular, Orthopedic, GI/Urology, and Minimally Invasive Surgery (MIS).

Medical device start-up that created a broad technology patent estate centered around breakthrough bowel management applications which it then designed, developed, manufactured, and distributed around the world.• Retained as consultant, then recruited to the executive leadership team; negotiated multimillion-dollar, multi-year development and production subcontractor deals for 2 bowel-management product lines; qualified and established global production/supplier base.• Key role in guiding the organization through strategic planning, forecasting, planning, quality systems and FDA approval (510K submission), production scale-up and launch, internal audits, conducted staff/end-user training, and maintained ISO 13485 certification of QMS. Implemented FDA compliant electronic documentation control database (Arena Solutions Product Lifecycle Mgmt software).• Co-authored and led execution of final assembly production test plans and approved process (PQ) validations.• Grew from zero to sales in 20 countries and multimillion-dollar annual revenue; acquired by Hollister Inc. for 15X assets.• Winner of 2004 MD&DI Medical Device Excellence Gold Award for innovative medical device which created a new standard of care, reduced hospital-acquired infections (HIAs), decreased hospital stays, and improved patient outcomes.

The Southern Technology Applications Center (STAC) at the University of Florida's College of Engineering in Alachua expedited technology transfer and economic development through affiliates in 9 southeastern states.• For More than doubled annual consulting revenue from engagements related to technology management, intellectual property (IP) protection, legal services, virtual manufacturing consulting, and market research consulting to more than 35 different industry, university, and non-profit organizations including Kennedy Space Center’s Technology Programs Office.• Managed technology transfer to VCs/private equity funds and the private sector for development and commercialization.

Delivered consulting services and provided access to technology resources to help help small- to medium-sized manufacturers in a 7-county Florida region become more productive and competitive.• Raised $250K in local cash match contributions from local government, businesses, and individual donors, in addition to in-kind donations for organization dedicated to strengthening competitive advantage for Florida manufacturing sector.• Co-authored Florida’s proposal and won $35 million, 6-year grant to fund network of 5 FMTCs across the state.• Established main office operations from site selection to build-out and opening; hired/trained staff, led strategic planning, and developed all policies/procedures aligned with corporate vision.• Identified top needs and priorities for manufacturers in the state and developed programs to address those needs, helped to protect existing revenue streams and add new revenue by analyzing operations and recommending improvements

A world leader in the design, manufacture and service of aircraft engines, industrial gas turbines and space propulsion systems.• As Innovative Partnerships Manager, cultivated relationships with non-profit organizations and federal/state agencies to secure grants to fund manufacturing technology centers, which were designed to keep commerce and jobs in the state of Florida. • Generated significant licensing opportunities for P&W patents.• Drove millions of dollars in savings through multiple improvements in processes, productivity, and production work-flow. • Recognized for outstanding contributions with the Pratt & Whitney Technical Executive Committee Special Award, United Technology Corporation (UTC) Presidential Cost Savings Award, and (5) P&W Employee Performance Awards.• Engineered the manufacture of experimental cutting-edge jet engine parts made from exotic metal and composite materials.• Developed test prototypes, soft/hard tooling, and authored component machining/fabrication methods.• Achieved 50% reduction in cycle time by using Factory Flow analysis software, QA cause-and-effect analysis, and work instruction standardization techniques