Matthew Steely Email & Phone Number

United States

Gainesville, Fl, Us

Specials Instrument Team•Leads monthly Specials meetings for Large Joints (Hip/Knee) and Extremities (Foot/Ankle/GPS) groups•Independent Reviewer for all Special Instrument development projects across Hip, Knee, Foot, Ankle, GPS business units•Released over 25+ Specials Instruments to U.S. Surgeons in 2 years•Leads the Instrument Servicing process and has saved the company 150K in 2 years by re-servicing instruments that come back from field use•Directly involved with continuous improvement of various standard operating procedures and internal work instructions (Special Instrument Development, Instrument Servicing)•Provides guidance to all Specials Instrument development users/teams to maintain consistency and compliance to Exactech’s procedures•Attends Cadaver labs and Sawbones assessment labs as required to ensure instruments meet user needs and internal design inputs•Reviews internal drawings for GD&T, Tolerance Analysis, and Design for Manufacturing•Authored and released a company-wide guidance document for Welding Exactech medical devices•Effectively self-manages several projects simultaneously•Consults with vendors, as required, regarding technical aspects of design and development projects•Assists and supports other employee, teams, and sales personnel as necessary•Maintains Smartsheet databases for Specials Instrument development and Instrument Servicing•Obtains feedback from surgeons to develop products•Provides design, engineering, and analysis direction to other engineers and designers in the development and maintenance of orthopaedic implants and instruments•Provides mentorship and professional guidance to junior engineers•Performs device evaluations•Assists in the resolution of manufacturing or quality-related issues•Applies engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, and inspection requirements and manufacturing process requirements

Amsterdam, Noord-Holland, Nl

Responsible for completing activities within schedule, scope, and budget, all while maintaining compliance to the product development cycleResponsible for ensuring compliance per FDA 21 CFR Part 820 for engineering related tasksWorks daily with cross-functional groups such as suppliers, contractors, manufacturing, procurement, quality, regulatory, and service in order to fulfill project needsPerforms routine engineering investigations involving calculations and/or tests in support of current products, new designs, methods, materials, or process studiesCurrent engineering team lead for a sustaining type 2 project (Gemini TF PET/CT System)Performed project management tasks when needed during a company restructuring by ensuring project status updates were provided to upper management and tracking ECO status with the engineering groups on a daily basisPerformed project management tasks on the Gemini TF type 2 project during the first two phases of development (Concept Realization and PPC-R)Active in process improvement activities within the engineering department to look for ways of becoming more efficient, eliminating waste, all while maintaining complianceReviews system and subsystem requirements to ensure engineering changes are fully traceable within the Philips verification and validation V-modelSupported the Ingenuity TF product re-launch through remediation effortCreate drawings, assemblies, and sketches using Creo (ProE), SolidWorks, and AutoCad software Authors technical documents such as protocols, reports, instructions, test proceduresLeads engineering technical reviews during product developmentProvides mentoring to interns and new hires as needed to achieve quicker on-boardingSuccessfully established a compliant refurbishment process for the Gemini TF PET Gantry product in order to support customersAssisted field service with full calibration and performance testing on a Gemini TF 64 PET/CT System at University Hospital in Cleveland

Mentor, Oh, Us

• Proficient with use of Pro-Engineer (3D CAD modeling) and PLM system to create parts, drawings, structure technical documents including design history files• Responsible for assisting technicians and designers in support of project assignments and goals. • Preparation of documentation, including configuration, DHF, etc.• Performs routine engineering investigations involving calculations and/or tests in support of current products, new designs, methods, materials, or process studies• Assists with design, development, testing and reports on engineering projects.• Interacts with vendors, suppliers, and consultants, on a limited basis, to assure compliance with requirements and specifications.• Works as a collaborative team member w/Marketing, Quality, Manufacturing, Service, Supply Chain, Regulatory Affairs, Vendors, Suppliers and Consultants in engineering projects• Involved with continuous improvement efforts for each project team (Lean principles)• Authors technical documents such as Protocols, Reports, Instructions, Test Procedures• Applies code/standards guidelines and requirements to product design (AAMI, EN 285)• Designs, develops, and implements activities required to support both new product development, and/or solve problems on current products, by applying skills in one or several branches of science and engineering. • Member of project documentation team to standardize AAMI and EN 285 documents (Test Protocols, SOP’s, and Test Logs) for the Research and Development group. Helps STERIS maintain VPP Star status by wearing required PPE at all times, attending safety meetings, recording monthly safety observations, and understanding environmental safety while working with steam or other chemicals.

Columbus, Oh, Us

• Initial concept and design of prototypes using Pro/ENGINEER Wildfire 3.0• Bring conceptual ideas to reality by engineering and detailing all components required to manufacture finished products• Responsible for detail drawings, cut-sheets, and renderings for new concepts and production releases • Perform time studies on production floor to look for improvements & cost savings• Create Bills of Material and routings using Mapics XA manufacturing software• Initiate and complete engineering requests as needed for sales and production• Support production during assembly and R&D prototyping to assure quality, efficiencies, and design integrity is being met• Travel as needed to support sales, discuss design intent, create conceptual ideas, and provide engineering feedback to customers• Additional production and field support by creating step procedures and installation manuals

• Initial concept and design of prototypes using Solidworks 2009• Responsible for finalization of designs for production phase • Development and maintenance of engineering drawings using Solidworks 2009• Provide project management support as needed (Bills of Material, sketches, drawings, presentations)• Provide engineering services with concepts, drawing packs, and labor requirements• Support production during assembly and procurement of parts• Support quality department during inspection and production phases• Provide final production drawings for purchasing department• Assist in development of ISO related procedures• Responsible for all Bills of Material lists and maintenance of part database• Travel as needed to test fit designs on military vehicles and perform live-fire testing• Provide engineering feedback of proposals as requested• Verification and validation testing at shooting range of designs

Itasca, Il, Us

• Perform validation testing for gas valves, thermostats, thermocouples, and thermistors• Setup and monitor of functional and validation tests on products using Labview software• Design test fixtures using AutoCAD v. 2005 and Pro-Engineer Wildfire software• Fabricate test fixtures using machine shop (Mill, Drill Press, Band saw, Shear, Brake)• Write test reports/summaries for all data collection and results (Microsoft Excel and Word)• CNC programming training• Perform shock and vibration testing for gas valves and thermostats• Equipment usage:o Thermotron (temperature and humidity chambers)o Neslab and Hart Scientific (temperature baths)o Unholtz Dickie electromagnetic shakero Digital air flow bench to measure leak and flow in gas valveso Omega (digital thermometer)o Keithley (digital multimeter)o Thermocouple and Fine Wire Weldero Blue M temperature ovenso Faxitron X-Ray machine

Richmond, In, Us

Power Brush Division• Perform Kaizen continuous improvement events for Lean Manufacturing• ISO 9000 and ISO 9001 Internal Auditor• Machine design with AutoCAD v. 2002, 2004, & 2006 and SolidWorks v. 2004 to detail components and assemblies for new and old production machines with geometric dimensioning and tolerance skills• CAD draftsman for all power application brushes, all SOFTOOL honing product, and all Millbrush product• Part ordering and purchase order entry using Osborn manufacturing database software• Operate machinery to prepare customer orders (Press and Bridgeport Mill)• Request and make engineering changes to products and processes using Microsoft Access software• Perform various load and stress calculations for Load Runners, MillBrush, and Power Brush Divisions using Microsoft Excel software• Work with customers and Osborn sales force to introduce special application brushes• Assist production floor engineers and work with machine operators to solve problems and help cut costs• Perform wear and spin testing on power brushes when needed for Quality Control department and Engineering applications department• Member of various special brush groups to analyze databases and help expand product line• Assist Quality department with wire tensile testing to qualify Osborn standardsLoad Runners Division• Develop drawing specifications and procedures for consistent drawing file management using Microsoft Word software• CAD draftsman and designer for all Load Runners product using AutoCAD v. 2002, 2004, & 2006• Request engineering changes to modify all current prints when customer or production changes need to be made• Perform destructive/non-destructive testing for Cam Runner assemblies to qualify loads and product life• Perform and maintain data calculations for all Load Runner product using Microsoft Excel software• CNC programming training using Gibbs Cam design software

Elyria, Ohio, Us

• Gearless Brushless FWD Arrow Project Team Member• New Product Development Group• Design prototypes using SolidWorks v.98, 99 modeling software• Assemble power wheelchairs• Prepare and monitor CTL tests• Procurement parts