SUMMARY

• Organized, Prioritize, Analytical, Creative thinking, TEMPEffective listening, Accuracy, Attention to detail, Problem Solver, Goal oriented.
• Electro/Mechanical Machine Design, Air Cooling breathing equipment, Capital Equipment Design, Systems Design, Process Fixture design, Optical Fixture Design, Optical Calibration Equipment Design Castings, Plastic Part disposables/consumables H/LV, Fluidic dispensing, Tool Design, Heat Sealer Design, Reference plates, trouble diagnostics, Minitab for statistical analysis R&R Gage and tolerance stack
• SolidWorks/PDM, 2000 - 2015, Pro-Engineer Creo 2.0,Windchill, Intralink, Vault PDM, SMARTEAM, DHF, FEA, CFD, COSMOS, MOLDFLOW, Surface design.
• High applicable knowledge of GD&T ANSI Y14.5, TOL STACK, UL,EUL, IEC 60601-1, ISO13485, FDA CFR 21, ISO 6,7,8, SAP
• Supply Chain management, Project implementation, IQ,OQ, PQ, Validation and Verification plans

PROFESSIONAL EXPERIENCE

Senior Mechanical Design Engineer

Confidential, Woburn, MA

Responsibilities:

• Redesigned a highly complex X-ray sensor array sled for cost reduction efforts. Reduced cost of design from $8,500 to for a price goal of $1800 or less, achieved goal was arrived at $1500 each for manufacturing.
• Establish unknown engineering design requirements based off of current design and interpret key mechanical criteria to be successful in maintaining a goal oriented product for cost savings.
• Coordinated wif the supervisor for design and exact specification requirements advising on production requirements and documentation.
• Implemented design using Solidworks 2015 and Vault to maintain a pdm control of all cad files and mechanical FEA analysis.
• Mechanical cad models where documented using Solidworks drawings. Design of sheetmetal and electro mechanical parts and assemblies. Established GDT directives to all mechanical models and drawings and checked into vault PDM.
• Communicated wif superiors on time goal and project status updates.
• Present final assembly of sensor array sled to team members for final review and manufacturing.

Product Mechanical Design Engineer

Confidential, Waltham, MA

Responsibilities:

• Worked wif timelines, milestones and budget requirements for demo device production.
• Managed resources, assuring that timelines and budget were met at all times.
• Coordinated wif the project manager for design and exact specification requirements advising on production requirements and documenting changes and issues.
• Identified key requirements for product review and plans, working wif documentation and teams cross functionally.
• Assured that product specifications, timelines and budgets were properly documented and tracked.
• Provided routine communication via email, and in person meetings to set up milestones and track product progress.
• Managed detailed documents, tasks and daily collaborations to assure product specifications were met in a timely manner.
• Demonstrated the ability to design an TEMPeffective product wif management and to create new ideas in surfacing design.
• Sole designer and design manager of company demo project to complete product launch.
• Product design of company display demo using Solidworks 2014.
• Design composed of complete plastics design introducing the integration of FPC, LCD, Flex Circuit design, Surfacing, knitting, manufacturing drawings, label application, bosses, IMD application, fastening and interlock design. Component introduction of design of barrel jack circuitry and micro usb. Size of demo actual I-pad size.
• Proof of concept design using high end 3D print equipment to show form, fit and function.
• Designed 3D material fixtures for LCD displays.
• Design of IR switch application circuitry used in display demo.
• Other projects consisted of IR touch for window interaction including sound, speaker application, testing and verification and manufacturing.

Senior Product Mechanical Design Engineer

Confidential, Wakefield, MA

Responsibilities:

• Worked wif global requirements including CE standards for medical product specifications.
• Communicated cross functionally wif project team to assure timeline, budget and resources were being managed in accordance wif product requirements.
• Assured that all detailed documentation was managed and tracked for product specifications, changes and production on time.
• Tracked the progress of the product on the timeline and budget basis as well as tracked resources were on time and production was running smoothly.
• Design product for ear canal scanning for devices used in earphones, hearing aids, safety devices.
• Team member development engineer focused on delivering mechanical designs for product development for high volume consumables.
• Focused on mechanical design for proof of concept medical device consumables, design of opto-mechanical motion control calibration equipment, plastic/silicon, fluid containment bags, and mechanical migration of fluid, products and design of electro-mechanical assemblies.
• Product design and delivery of high volume products for pilot builds of over 10,000 in consumable pieces. Solved various engineering problems wif associated form fit and function of medical device design for manufacturing. FMEA application to consumables and other products from designs
• Design of fixtures related to assembly testing and verification.
• Solved molding issues related to mold design for quality product delivery.
• Solidworks 2013 CAD design of surfaces, lofts, for newly design parts for application to current design
• Devised protocols for shipping, packaging and impact testing for consumables. Convey validation, testing procedures for various devices designed.
• Redesigned motion control fixtures for improved repeatability in the calibration of optical scanning devices.
• Design of servo lift elevator for the movement of fluid to consumable.

Senior Mechanical Engineer

Confidential, North Reading, MA

Responsibilities:

• Performed investigational internal resolutions to quality production requirements and wif internal customer issues wif released products for manufacturing. Integrated wif various sustaining engineering departments to provide real engineering solving problems to meet DFM value and cost down streaming initiatives.
• Collaborated wif operational managers to resolve manufacturing issues wif foreign products manufactured to be delivered for sale in the USA in conjunction wif supply chain initiatives.
• Provided product development consulting on new released capital testing equipment from foreign manufactures. Resolved technical issues pertaining to EM packaging, sheet metal design, mechanical integration of parts and large complex mechanical assemblies.
• Devised best course of action to remediate current issues wif mechanical and electrical problems and its requirements.
• Recommended changes in design for manufacturing based on DFM/DFA design principles. Investigated fabrication and remediate large and small casting DFM problems wif supply chain team for technical fit and tolerance analysis and solved these issues wif foreign manufactures.
• Individual role was transferred internally to NPI for new development of semiconductor testing. Responsibility to solve current issues and bugs found in manufacturing of newly designed engineering high level assemblies.
• Application of FEA to determine stresses and strains on various parts for design change when ECO's where established.
• Analyzed current machined design drawing documentation to meet ANSI Y14.5 GD&T adherence. Solidworks 2012, Smarteam and PRO-E Creo 2.0 Interlink.

Opto-Mechanical Design Enginee

Confidential, Wilmington, MA

Responsibilities:

• Reengineered existing using Solidworks 2013 CAD machine design models and performed risk assessment to opto-electro/mechanical calibration components for a three-dimensional (3D) measurement system for a hand held intra oral dental scanning device.
• Reduced existing mechanical machined errors to kinematic mounts and improved triangulation integration of motion control hardware for calibration and verification of optical mechanical alignment testing wifin the calibration station. Provided internal FEA/DFMEA criteria to the redesign for manufactured components for production.
• Plastic part design of various enclosures, parts connectors, ribs bosses, containment fixtures
• Designed sheet metal supports/chassis parts, for PCB boards to provide thermal efficient cooling air flow through the entire electromechanical package. Emphasis on IEC 60601-2-2 for medical device Class III. Re-evaluated existing documentation and corrected current mechanical drawings from any inefficiency for transitioning work to internal/external vendors and for production manufacturing. Collaborate wif machinist for component fabricating for mechanical optical fixtures and sheetmetal parts.
• Directed goal was to design and document various combinations of orthopedic knee joint implants such as cast tibial interlock shelfs and high density polyurethane plastic knee inserts for iTotal® knee implants for product release and manufacturing wifin a R&D department. Created multiple Solidworks 2011 CAD configurations of models and drawings for the support of DHF/PDM quality systems and marketing.

Mechanical/Manufacturing Design Engineer

Confidential . Watertown, MA

Responsibilities:

• Developed mechanical fixtures for the aid in manufacturing, test and inspection for a polymer based FIMA stent for clinical trials.
• Design for the application of 80/20 parts to modify existing equipment for automation
• Specification, sourcing, and application of machine designed specialized parts and sensors for automation application for stent coating.
• Reengineered electro mechanical coating automation equipment to aid in the install of stents for polymer coating in customized process PLC mechanical automation equipment. Guide and support pilot manufacturing builds including actual building and performed internal QC inspection criteria. Test devices and analyze results using various electromechanical radial force equipment to gather statistical data analysis. Wrote and created work instructions for various manufacturing hands on assembly as well as for the use of sterility operations and procedures.
• Took lead responsibility in providing validation of clean room manufacturing and it sustainment of meeting standards for ISO 7 8 9.
• Lead product development design lifecycle and creation of a disposable micro-needle medical device used for hormone treatment for clinical trials.
• Designed various multi-forming tools for needles and provided proof and verification to the design and risk analysis.
• Designed plastic pod case packaging for the containment of holding a micro-needle array and other medical components included researching medical grade plastics and textile materials for product development and manufacturing. Design of optical measurement and locations of drug on needle array using cameras and vision locations systems on robotic XY platform table.
• Designed hand actuating mechanism for the application of a mircro needle to the epidermis layer of skin. Experience working in and creating documentation for medical device design control systems.
• DFMEA to DHF and product development.
• Created DHF for QC initiatives in the document control of products designed for clinical trials. Developed ECO’s/DCN for the creation of drawings for initial release for development and manufacturing of medical goods quality systems. Designed newly created clean room and assembly fixtures for manufacturing production initiatives. Experienced wif designing micro fluidic instrumentation devices actuating mechanisms for drug dispensing. Extensive Solidworks use wif version 2010-11 and GD&T adherence

Designer/Private Consultant

Confidential, Everett, MA

Responsibilities:

• Using Solidworks 2009, Custom designed hand surgical devices specializing in neurosurgical and orthopedic applications such as Curettes, Tapered Suction Tubes, Elevators Dissectors, Retractors, Nerve Hooks, Nerve Root Retractors, Arthroplasty Gouges and specialized instruments. Performed verified GD&T tolerances to new and old drawings and provided the update to device history files. Performed internal investigations on current designs for manufacturing validation procedures for continues onsite improvement to promote FDA compliancy and ISO 9001:2000 compliancy.
• Using Soldiworks 2007 performed mechanical designs of machined parts, sheet metal parts, aluminum castings, weldments and fasteners incorporated into large and small mechanical capital equipment assemblies. Performed ECO revisions wif the aid of SmarTeam PDM software. Manipulated sketches to reflect changes wifin parts and assemblies. GD&T application of new and revised drawings.
• Responsible to ensure materials are available on a timely basis to fully support all manufacturing, product development and R&D activities. Prepared request for proposals, bids and other similar and necessary documents related to the purchasing of product to support manufacturing, product development and R&D. Analyze quotations for new components from current or new suppliers in a manner that is consistent wif the sourcing strategy. Worked wif Solidworks 2008 to implement drawing packages from PDM packages. Submitted drawings to suppliers for quotes using PDX package processing. Worked wif various customers to manufacture mechanical products, electrical board fabrication, software and cable routing harnesses. Assisted suppliers to ensure that selection, development, and validation of manufacturing processes, equipment and tooling are performed to the meet engineering requirements. Initiated SCAR to customers that need to change or improve on their manufacturing process or procedures.
• Designed and created soft lens cleaning manufacturing process equipment to be used in lens manufacturing facilities. Performed in-house R&D development of such fixtures and the application of electro/mechanical components such as pumps, adapters and specialized fittings and sheet metal parts using Solidworks 2008. Collaborate wif outside machine shops to manufacture multiple parts and devices. Engineering and project management skills in the scale-up of new products, the improvement and refinement of existing processes and equipment and the support of existing manufacturing operations.
• Under very limited supervision of the Directing Manager of Utilities and Production Services, I successfully and individually performed intense onsite investigations of mechanical equipment needed for VPP safety evaluation. Logistically located and identified all the safety devices on P&ID’s using current company maintenance and other software for investigational and validation purposes. Communicated wif all working EVM and MEM departments to investigate, identify and compile all safety devices for corporate review and evaluation. This included collaboration wif building facilities, planning and engineering services.

Lead Mechanical Design Engineer

Confidential, Rockland, MA

Responsibilities:

• Mid and late-stage development and technology transfer activities for an in process FDA approved genetic medical temperature test instrumentation(FlowCytoMetry) and plastic (vials) consumables for laboratory and in-vitro diagnostic applications. Worked wif various manufactures to implement product take off and market.
• Established FAI for tooling for product consumables and acceptance for tooling. Approved or disapproved the acceptance of tooling production. Provide the technical support and input to purchasing and material/component part suppliers. Obtained and prepared materials needed to carry out consumable parts and medical genetic test laboratory using equipment evaluations.
• Analysis of thermal and air flow characteristics around vial for validation and verification. Vial design to compete wif Roch Diagnostic devices.
• Carried out specified prototyping, formulated product testing, tooling/ fixturing design, generated test protocols/reports, data analysis and provided assistance in process validations. Drafted instructions for equipment use and standard procedures, material specifications and equipment specifications as needed. Provided cGMP validation of procedures and incorporated documentation of various SOP for maintenance of environmental clean rooms. Provided technical and logistical support as required in all phases of product development life cycle.
• Designed new safety products for welders such as browgaurds, ADF optical filters and the new design of vortex air cooler for welders using Think 3 and SolidWorks 2004 Design software.This included applying and testing of NIOSH regulations and safety standards. Responsible for introducing new foreign product into US market sales into the welding industry. Created working user manual documentation for new product introduction for AC/DC welders. Revised and updated various product manuals based on new regulations for welder safety and proper distribution. Perform ECO changes to Drawings (Isometric), bill of materials and of graphs. Researched the selection and application of various plastics to conform to passing heat, stress, flexibility and mold ability requirements.