Responsible for supporting both internal and external customers in designing, building, documenting, & deploying custom automated machines to a variety of industries.

• Co-owner along with my talented Wife, who runs the daily operations• Bookkeeping and tax preparation via Quickbooks• Quote creation and invoicing• CAD design of custom chocolate molds• Fabrication of chocolate molds via 3D printing (resin and FDM), thermoforming, edible ink and silicone• Capital equipment procurement and ROI calculation• Employee hiring and retention support• Development of advertising copy (local, radio, print and social media)• Google analytics and response to customer reviews• Website design support and content creation• Wholesale contract negotiation• Cybersecurity and PCI Compliance• Planning of community support, charity and fundraising activities• Building maintenance and improvement• New product research, competitor bench-marking and, of course.....taste testing

• Design, fabricate, validate and implement automated and semi-automated fixtures and machines for medical device assembly.• Create, develop, and maintain written instructions for manufacturing processes• Develop and implement process controls for manufacturing to ensure repeatability, reliability, and quality of products &processes• Provide training to production personnel on manufacturing processes• Design, develop, and perform verification/validation testing as it relates to manufacturing processes, equipment, assemblyfixtures, etc.• Work with Research and Development in the transition of products into production• Research, source, and design equipment as it relates to the manufacturing process• Work with various groups within the organization on CAPA related projects• Work with various groups within the organization on complaint investigations• Ensure manufacturing processes are in conformance with ISO and FDA guidelines• Participate in service trend analysis for regulatory compliance• Recipient of "Impact Player Award" - nominated by peers• Keywords: IQ/OQ/PQ, ISTA, PLC Programming, Solidworks, CAD, Lean Manufacturing, 5S, V&V, ISO 13485, CAPA, FMEA, DFMEA, PFMEA, DFMEA, DFM, DFMx, SCRUM, cGMP, SOP, DHF, DHR, DMR, MVP, Validation Protocols and Reports, COGS, QMS, Robotics, Automation, Machine Design, DOE, MinitabPlease see recommendations from 25+ peers and colleagues below. Outside of work:- Chairman of town recycling committee- Member of town Conservation Commission- Small business owner- Biking, hiking, skiing, 3D Printing, microscopy, fabrication and automation

• Lead team of Manufacturing Engineers to execute the tasks captured above.

• Setup multiple manufacturing lines for the assembly of medical devices including process flow definition, fixture selection, validation of individual pieces of equipment and development of protocols to execute Manufacturing Validations (MV) for finished devices. Drafted final validation reports for customer QC and Engineering. • Worked closely with New Product Development to transition products to manufacturing; drafting of component specifications, DFMA activities, vendor selection and qualification, PFMEA, definition and setup of preventive maintenance, equipment and process validation, engineering builds, manufacturing validation builds, and training of production personnel. • Designed, fabricated and programmed custom assembly and test fixturing and validated per IQ/OQ/PQ methodology.• Supported Lean Manufacturing transition to one-piece-flow.• Redesigned company Preventive Maintenance program to ensure compliance and improve record of execution. Scope includes production fixturing, environmental controls (particulate and HVAC), utilities and clean room janitorial.• Designed a format for Work Instructions based upon the Toyota Production System (TPS) which reduced training time while improving clarity using images and minimal text.• Experience and proficiency with: ISO 9001:2000 and 13485:2003, cGMP for FDA-approved Medical Devices, IQ/OQ/PQ, Quality Inspection Tools and Methods, Lean Manufacturing, Pad Printing, Laser Welding, Ultrasonic Welding, Kanban Material Management, Tray Sealing, Band Sealing, Root Cause Analysis and Problem Solving (PDCA, A3, Pareto, Fishbone).

• CNC and manual machining• Machine maintenance, deburring, polishing, cleaning, packaging and shipping • Part file manipulation in SolidWorks

• Residential, commercial and industrial installation and repair

• Property operations support including installations, repair and energy efficiency retrofits• Recipient of “Stowe Gold Star” award for exemplary service• Ski tuning, repair and rental support• Implemented safety improvements on Wintersteiger ski tuning equipment

• Repair, assembly, sales and general customer service.