Charles Lynn Email & Phone Number

Kettering, Ohio, United States

LIGHT work .

Sw Ohio

VELYS , Digital Surgery and Orthopedics Robotic Assisted System - Design Quality Engineering - Supplier Quality Engineering - Product Development / Design Transfer - US launch, US LCM, EU / UK launchVELYS Spine System , Digital assisted surgery, pre 510k company acquisition work

Lake Forest, Illinois

Lake Forest, Illinois

Hospira was an Abbott spin off which was acquired by Pfizer in 2015 and the medical device portion later sold to ICU Medical in 2017

Lake Forest, Illinois

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 companyKey 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.

Lake Forest, Illinois

Orthopedics Capitol Of The World ( Warsaw, Indiana)

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 ExtremityUS R&D Organization : Warsaw Design CenterDesign Center : Product and Process Development & TransferReported to VP of Quality and Regulatory, Reported to Director of QualityAchievements:- Site Quality Systems rep 2012 ISO 13485 Recert Audit2011 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

Cincinnati, Ohio

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 ReconstructionReported 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 auditsProduct 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

RF Electronics - Defense IndustryQuality Engineering - Maufacturing- Harris Six Sigma/ PPAP Qualification for Minipole RF Filter- Manufacturing support for $30M sales for PZ Standard products portfolio- Customer Returns Analysis

Security Printing / Brand Protection/Anitcounterfieting IndustryReported to President and FounderFramework provider and lead resource for Quality and Security Risk Managment- Start up organization- NASPO Class I

Security Printing and Brand Protection/ Aintcounterfieting IndustryReported to President and FounderFramework provider and lead resource for Quality and Security Risk Managment- Start up organization- NASPO Class I

Cincinnati,Oh

Imaging - Medical Device IndustryReported to Site Quality Manager Quality Engineering - Supplier/OutsourcingQuality Control Supervision - Incoming InspectionOperation Excellence - Black BeltNew 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.

Imaging - Medical Device IndustryQuality Engineering - Supplier/OutsourcingQuality Control Supervision - Incoming InspectionOperation Excellence - Black BeltLean /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.

Greater Nashville Area, Tn

Transportation Tickets and Gift Cards - Speciality Converting Industry Reported to VP Quality, Sales and ARC ServicesQuality Enginering - manufacturing, supplier, distribution, technical customer supportAirlines Reporting Corporation (ARC) Technical Resource - all phases of business programGift 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 encodingAirlines Reporting Corporation - ATA/ IATA & Product Development Technical Advisor, manufacturing, CRS consult, Distribution, Travel Agency complaints investigtor, LPB ( Loss Prevention bullletin) investigator magnetic striping cards

Cincinnati, Ohio

Packaging and Labeling - Converting IndustryReported 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 labelsSupplier Devleopment

Bs, Physics

Activities and Societies: Intramural basketball, football

Ms, Physics

Activities and Societies: Sigma Pi Sigma

Education record