* Broad ranging experience in theoretical and experimental studies, Quality Engineering, Research and Development, Product Development, Manufacturing, and Sourcing Management experience * Experience with Medical Device class I,II,III ( imaging, orthopedics, infusion pumps, disposables/ consummables) * Converting and Security Printing processes, and electromechanical / SW applications * Defense Electronics * organizations of all sizes and ownership / management phases ( start up/ founder, start up / angel investor to venture capitalist, , start up/ pre IPO, post IPO, small private, small public, medium private, medium public, large public 97,000 plus employees) * Interest in start ups transtioning to small companies

Manager, Medical Device Sourcing @ From September 2015 to Present (4 months) Manager, Medical Device Sourcing @ From June 2015 to Present (7 months) SR Hardware Engineer - Serialized Devices @ Hospira is the world leading supplier of infusion technologies and injectable drugs. My mission is to assist the company in its overall Device Quality Initiive and Compliance Master Plan activities to improve , streamline, and build world class infusion pump technologies. My role is R&D Device Quality oversight for new product development projects, Quality Engineering support for OnMarket PLUM A+ projects. The PLUM A+ are software driven , wireless and non wireless, AC and Battery powered , electro - mechanical , general IV infusion pumps which are the workhorse pumps of the company Key accomplishments : - strategic seasoned targeted outside resource hire for quality engineering impact in support of Hospira Device Quality Initiative and Compliance Master Plan to remediate QS and deliver next generation infusiin pumps for Plum A+ and PCA including a 2 yr intense effort to lift FDA US - Import ban on infusion pumps. - NSAI ISO 13485 reinstated - Import ban lifted on Jan 5 2015 to US and Canada - Plum 360 with Hospira MedNet recieve 510k clearance on Jan 16 2015 - Plum 360 recieved CE mark approval from BSi on Jan 23 2015 - Plum 360 R&D Device quality engineering for product development V&V and development / risk management acitivies. - Plum A+ R&D Device quality enginering for Plum A+ Restart domestic and international wireless ( 13.x) and nonwireless ( 11.x) projects. - Over 45 Plum platform projects multitask supported for quality engineering, design quality, design controls, engineering V& V protocols / reports, sample size determination, measurement systems, supplier quality, process validation, Enovia engineering change aprovals. - DHF assessments and audits, Design Reviews, CAPA, Risk assessment, Product Surveillance. From February 2013 to June 2015 (2 years 5 months) SR Quality Engineer @ Tornier was a Top Ten Global supplier of Implant and Instument Systems for the Orthropedic Industry. My mission was to provide Quality Management and Engineering oversight for the US Design Center. Tornier was an European based company which was financially leveraged with a venture capitol group to purchase 4 small companies in the US and integrated to establish a US footing for growth of the company. Company achieved IPO in 2011 and over 1 B in market capital. Orthopaedics - Shoulder, Sports Medicine, and Distal Extremity US R&D Organization : Warsaw Design Center Design Center : Product and Process Development & Transfer Reported to VP of Quality and Regulatory, Reported to Director of Quality Achievements: - Site Quality Systems rep 2012 ISO 13485 Recert Audit 2011 ISO 13485 Surveillance Audit ZERO Major or Minor nonconformances - 2011 Tornier Project of the Year - CE release of Simplciti Shoulder System - FDA IDE of Simplciti Shoulder System - FDA clearance of Simpliciti Shoulder System ( Mar 2015) - CE and 510k clearance for Insite FT TI and PEEK Suture Anchor products - Insite FT BIOCOMPOSITE From May 2010 to February 2013 (2 years 10 months) SR Quality Engineer @ Integra LifeSciences was an integrated medical device company serving the neurological , and orthopedics industries. My mission was to provide Quality management, systems development, and engineering support of the start up of new product development for the orthopedic side of the business, and support of the KMI purchased product lines. The site was picked to be the US new product development, supplier outsourcing and management , and warehousing and fulfillment and kitting center. Orthopaedics - Extremity Reconstruction Reported to Director of Quality Quality Engineering - all phases of organization - Product Development, Operations, Supplier /Outsourcing - 2 New Product Development Projects - Completed - KMI and NewDeal Product portfolio ( $16M sales domestic and international) - Complaints Analysis - Internal / Supplier / Third party audits Product Development...... role serving all product lifecycle phases ( inititaion, development, manufacturing, outsourcing, supplier development, incoming inspection, kitting and distibution, engineering maintenance) Process Validations, Design Verfications, Design Validations, Risk Managment, Quality Systems Managment, Quality Engineering and Statistical / Empirical support for facility Kitting Operation From June 2008 to April 2010 (1 year 11 months) Quality Engineer @ RF Electronics - Defense Industry Quality Engineering - Maufacturing - Harris Six Sigma/ PPAP Qualification for Minipole RF Filter - Manufacturing support for $30M sales for PZ Standard products portfolio - Customer Returns Analysis From August 2007 to June 2008 (11 months) Director of Quality and Risk Management @ Security Printing / Brand Protection/Anitcounterfieting Industry Reported to President and Founder Framework provider and lead resource for Quality and Security Risk Managment - Start up organization - NASPO Class I From November 2006 to August 2007 (10 months) Quality Manager @ Security Printing and Brand Protection/ Aintcounterfieting Industry Reported to President and Founder Framework provider and lead resource for Quality and Security Risk Managment - Start up organization - NASPO Class I From November 2006 to February 2007 (4 months) SR Quality Engineer @ Imaging - Medical Device Industry Reported to Site Quality Manager Quality Engineering - Supplier/Outsourcing Quality Control Supervision - Incoming Inspection Operation Excellence - Black Belt New Product Development Team - $41M ( 80% COGS) Supplier Budget - Principle resource for all of supply base for the organization ( 18000 sku's) - flexible management of up to two full time and three part time QC inspectors - black belt projects ( completed addtional requirments for International version of Tyco Heatthcare Certified Six Sigma Black Belt as well as ASQ Cert SSBB) - two New Product Development projects - Lead Process Validation Team for Nuclear Medicine Elution Device Technology : printed circuit boards, wire and cabling, castings, fabrication / sheet metal, injection molded components/assemblies, machined components, extrusions, LCD displays, touchscreen displays, Infimed Imaging systems, sensors, transformers, heaters , Xray grids, radiation shielding, labeling, IFU's, printed tech/ service manuals. From September 2000 to November 2006 (6 years 3 months) Quality Engineer @ Imaging - Medical Device Industry Quality Engineering - Supplier/Outsourcing Quality Control Supervision - Incoming Inspection Operation Excellence - Black Belt Lean /Kaizen - $41M ( 80% COGS) Supplier Budget - Principle resource for all of supply base for the organization ( 18,000 sku's) - flexible management of up to two full time and three part time QC inspectors - black belt projects ( completed requirments for Tyco Heatthcare Certified Six Sigma Black Belt) - Lead two Lean / Kaizen Events for Incoming Inspeciton with 5000sq ft reduciton, $15k overtime reduction, and transition to visually managed area with FIFO rotation with Hot lot provision. - Completed 5 Six Sigma proejcts - Six Sigma and Lean Events resulted in over $800k of savings and inspeciton que reduciton from 6 months to 2 days. - Improved % Dock to Stock from 41% to 80 % hitting critical limit goal ( ie service parts, revsion change turnover,new product introduction) Technology : printed circuit boards, wire and cabling, castings, fabrication / sheet metal, injection molded components/assemblies, machined components, extrusions, LCD displays, touchscreen displays, Infimed Imaging systems, sensors, transformers, heaters , Xray grids, radiation shielding, labeling, IFU's, printed tech/ service manuals. From March 2000 to September 2004 (4 years 7 months) Quality Engineer @ Transportation Tickets and Gift Cards - Speciality Converting Industry Reported to VP Quality, Sales and ARC Services Quality Enginering - manufacturing, supplier, distribution, technical customer support Airlines Reporting Corporation (ARC) Technical Resource - all phases of business program Gift Cards product development - $24M ARC business technical liason for all phases of ARC business ( of a $65 M sales organization) - Ran ARC qualification process for new speciality themal papers - ATA/IATA 722e specifcations - Generated $50k annual and growing addtional sales with ARC Loss Prevention Bulletin program while solving issue of removing blacklisted serial numbers for ATA - Primary technical support for ATB printer OEMS, speciality paper suppliers, Computer Reservation Service suppliers - Provided Technical Support of over 44,000 domestic travel agencies - Reduced costumer complaints from over 5% to under 0.1 % Converting Processes : Flexogsraphy, magnetic striping, coating, laminating, slitting, diecutting, numbering, barcoding, security printing and encoding Airlines Reporting Corporation - ATA/ IATA & Product Development Technical Advisor, manufacturing, CRS consult, Distribution, Travel Agency complaints investigtor, LPB ( Loss Prevention bullletin) investigator magnetic striping cards From June 1995 to March 2000 (4 years 10 months) Quality Engineer @ Packaging and Labeling - Converting Industry Reported to Director of Quality Quality Enginerring - printing, finishing, customer applications - Quality improvment initiatives under direct leadership of the Director of Quality for Campbell Soups ( $20M sales) Wrigley's Gum ( $12M sales) resulting in retainment of those customers ( total of $32M out of $65M sales) Converting processes - Rotogravure,Offset,Letterset Printing, polar cutters, diecut cutters, INMOLD labels Supplier Devleopment From May 1994 to May 1995 (1 year 1 month)

MS, Physics @ Miami University From 1990 to 1992 BS, Physics @ Indiana University Bloomington From 1985 to 1989 Charles Lynn is skilled in: Six Sigma, DMAIC, Design Control, Quality Control, Supplier Quality, Quality System, FDA, Management, Manufacturing, Continuous Improvement, V&V, ISO 13485, Start-ups, Validation, Kaizen