New Products Development (NPD) for Fleet Management.

Provide all aspects of Mechanical Design Engineering & Technical Illustration expertise to clients throughout the US and Southern Asia Territories.

Design of Mechanical fixtures used to develop contact lenses.

Design of all products related to Fleet Management. Hose & Tag Module, Station-based Terminal Cabinetry, Truck-based Terminal Cabinetry, User Interface products, Vehicle mounted Canceiver, etc. Sheet metal, rugged and soft plastics, electronic component placement. All products are designed and tested for harsh environments.

Design of Pill Sorting Ideations for Flextronics client. Design of DC power train for handheld Medical instrument. Design of Automated assembly of Handheld medical instrument.

R & D: Design of Haptic Robotic Products & Co-functional Instrumentation for medical, commercial & military business entities. Design of Haptic product Add-Ons, ergomonic handles, ergonomic digital enhancement features of highly complex structural complexity. Mechanical Design Engineering of Haptic Robotic Digital Fidelity (force-feedback digital impression). Mechanical Design Engineering of Enhancements to existing products. Mechanical Design Engineering of Customer Specialty Applications. Mechanical Design of Haptic Robotic Medical Instrumentation & Add-Ons for specific medical applications including Cardiac Catheter Drive Systems/Dental Surgical Tools/Implant products/High-fidelity Dental & Occular surgical applications, Cranial Refitment Surgical Applications, etc. Haptic Catheter Controller for Beating Heart Surgery. I designed the current “Grasping Haptic Devices (Add-On Tools)” for use across various industries per Customer Requirements (AKA: “Custom Apps” design/development). Redesign of multiple Haptic-Robotic products for immediate Market Re-entry Improvements for Direct-To-Market Production. Includes Project Management & Oversight of Domestic Products total management of SensAble’s PanYu, China Product Manufacturing and Guangzhou China based Resellers. Performed all V&V Testing.NPD for Domestic Manufacturing: Design & testing of products specialty Jigs & Fixtures for MFG, specialty assembly applications, design/development & revision of manufacturing specifications as well as AP (Assembly Procedures) develpment.Off-shore Manufacturing: PanYu, China; development of manufacturing pathways. Design/develop manufacturing aids (jigs & fixtures), design of cross-technical applications bridging US & Asian manufacturing requirements. Develop & maintain scheduling. Manage 300-500 unit/month shipment schedules. Bi-annual visits to facility provided Jetta Manufacturing with engineering revisions, production support, QA/QC improvements & shipping scheduling.

Consulting Contract: Total Product Design of Levelert-2, battery powered Fluid Level Sensing device used in Arthroscopic operating theaters. Design proved to be DFM/DFA efficient through compact layout to assist head pressure height and minimum parts to assemble. (Ref. Sam Shener, Director R & D).

Consulting Contract: CR Bard, Billerica, MA: NPD for Gastro-Enteral interface product design. SW-2004, CW-2004, MoldFlow, PPT, etc. 1 Patent received. (Reference: Jim Wilkie, Project Manager).

ADR Contract: Nu-Tool, A division of BioMold, Andover, MA: I Designed Plastic Medical Part and Mold Inserts including the Design Graphics. SW-2004/CW-2004, MoldFlow. (Reference, Bill Stanhope, Manager, R & D).

ADR Contract: Design & documentation of Cranial-Cooling Headset & Sheet-metal Console. SW2004, Cosmos. (Reference, Chuck Lennox, President/Owner).

ADR Contract: Product redesign, redevelopment, and Corporate Submission Level documentation (Develop all ECR's & Develop all DHF's) of single use Catheter-Driving & Manipulator Product. Given 6 months for competion, I completed the entire Product & Project in 6 weeks.

ADR Contract: Product redesign and enhancement through CosmosWorks FEA software, V&V and Feasibility studies. Design of user interface mechanical assembly, prototype mechanisms for phase 1 and phase 2 engineering analysis, documentation, project management, SolidWorks & CosmosWorks.

ADR Contract: Foxboro, MA: Computer Product redesign project using SolidWorks. FEA using CosmosWorks (Linear & Non-linear for PEK & PEEK, etc.)

ADR Contract: Product redesigns for Single Use Safety Needle of various configurations. Documentation, Assembly Procedure for full-depth manufacturing. Now known as the current JNJ Safety Needle for Phlebotomy/Phlebotomists worldwide.

ADR Contract: Pericardia Merrimack, NH (1/2000 to 12/2001): Design & documentation of patent-pending designs involving myocardial stent implantation and closure. Includes generating ideas for NPD and procedure invention. (8/2003 to 12/2003). SW2004, CosmosWorks. (Reference: Larry Roth, President, R & D).

ADR Contract: Managed design of medium to large-scale projects from conception to Phase 2 prototyping in team settings. I coordinated multi-discipline inputs for project throughput. I was directly responsible for the Design of complex products, jigs and fixtures, small and large-scale mechanisms using SW2001+/CosmosWorks. 1 Patent received, other patents were pending). (Reference: Tom Johnson, Manager, R&D, Denis LaBombard, R&D, Frank Patterson, R&D.)

Contract Employment: I created the Product Conceptualization & Design of a “Pulmonary-Thoroscopic Staple & Buttressing Product” using biocompatible, non-natural (ePTFE) material for LVRS (Lung Volume Resection Surgery).I created the Phase-1 Product Conceptualization & Design of the “Thoratec “Anti-Kink” Over-tube” Product through Engineering-Structured Design, Development, Manufacturing Processes, QA & QC-Protocols for testing (DoE) via Atrium’s patented ePTFE Product & Process.I was responsible for Full Product Design incorporating all engineering and FDA targets & standards through project management engineering functions including Product Performance Specifications, Scheduling, and Patent Review & Strategy (IP). I performed research for proprietary (expanded-use-of-products) development programs. Software: Pro/Engineer V20, 12 months. SolidWorks, MS-Project.OEM Projects Manager: Managed all phases of Product Development including writing manufacturing, quality, product testing, process qualification and validation testing and packaging procedures. I coordinated the manufacturing efforts for delivery deadlines including design, testing, and implementation of manufacturing equipment used for development and long-term manufacturing plan. I was directly responsible for the implementation of long-term development programs (products and full system integration) for OEM based programs. I developed a multi-departmental “Build Manifest Program” for a Long-term automated Build-To-Order Structure to be implemented as a corporate-wide system through Document Control and Training. Projects Manager for NPD through multi-disciplines at all levels (R & D, Production, QC, QA, Packaging, Sales, etc.).

Direct Employment: New Products Development Engineer, Group Leader, R&D: I created the “Complete Design” of GERD Tissue Manipulator & Permanent Fastening Product. Full product design and engineering functions including Stress Analysis, Product Performance Specifications (PPS), Test Protocols & Manufacturing Requirements & Documentation. Provided Project management, project updating, and creator of Industrial Designs & Graphic Art presentations. Software: Pro/Engineer V19, 8 months. Win95, Excel.Product Development Engineer/Project Manager, R&D (1/97 to 3/98):I managed the development of The First BSC Hydrophilic Biliary Canal Balloon Catheter Product through R & D and Manufacturing Team Program Management role. I submitted a “Letter-To-File (LTF) approval in March 1998.

ADR Contract: New Products Development Engineer, R&D:Oversee staff in the development of balloon products used for Angioplasty. Managed component assembly and packaging operations for new balloon product line. V&V Testing potocols, FLTS Protocols & testing for project reporting to Senior staff.

Direct Hire: Various duties included re-design of Intra-Aortic Blood Pump (IABP) Ambulatory Transport Cart including Documentation of all mechanicals incorporating GDT & ANSI Standards. Recipient of the “STC Medical Products Airworthiness Certificate" in 1995, Awarded for “Full Reporting with Zero Re-Admittance Questions” required, a “First-Ever” for The STC Air-Safety Approval Board. I performed the Design & Development of the Manual Drive Blood Pump.Cardiopulmonary Support Console (CPS): Redesign of outdated console to retrofit new circulatory components (blood pump, blood filter, and heat exchanger, etc.) for reintroduction to the market. This required the Total redesign of a new Blood-Flow System and Filter/Heat Exchange & Component Holders to Retrofit all Single Use Tubing Sets, 3 way valves, inline filtration, in-line manifolds, redesigned bifurcates, redesigned thermoform tray packaging, etc. I coordinated & managed 4 teams for component testing as well as assembled circuit system performance in accordance with console and accessory circuit DFU claims. Product was released to market under Letter-To-File Regulatory status. Software: Pro/Engineer, Hewlett-Packard ME-10, and MS-Windows Software Tools.

Mechanical Designer, R&D, Cardio-Thoracic Products & Systems: Design of 10 New Products & 30-40 Product Improvements (existing Patented Products including Blood Pump Electronic Console as well as The Emergency “Manual Drive Blood Pump”, Blood Capture & Recirculation Devices, Cardioplegia-related products (Heat Exchange, Fluid Dynamics), Various Cannulas, Percutaneous Accessories Kits including Single Use Tubing Sets, Port-to Port 1-to-3 way valves, inline filtration, Port-to-Port Manifolds (Various sizes for Pediatric & Adult Surgical Procedures), Various numbers of separate Bifurcate Tubing Connect Components, Thermoform Tray Packaging, corresponding documentation, etc. I designed all Product Prototype units, DOE, FEA, FMEA and Quality Control Specifications for PDTN as well as all MFG-equipment, Jigs & Fixtures. Test Station design/debug, Machine and mechanism design/debug for product manufacturing and pre-release production equipment (i.e.: pneumatic, synchronous motors, and gearing dynamics, tension control and various mid-/high-end Complex Mechanisms used for Prototyping & Proof-of-Principle for approval and transition directly into manufacturing). I developed all documentation from R & D Conceptualization to PDTN Assembly Procedures to full product BOM drawings/mechanicals (using GDT & ANSI Standards).Software: Pro/Engineer, Revision 8, 6 months. Hewlett-Packard ME-10. Windows.

ADR Contract: Design and testing of molded plastic parts for use in consumer photography products including drawings using GD&T & ANSI Standards. Part and assembly DFM/A analysis, Risk analysis (FMEA), multi-directional, multi-functional link assembly analysis. Member of design team sharing 4 patent applications. Design of product test fixtures and Manufactruring Test Stations (cells) for assembly testing and production readiness, V&V testing. Machine design and complex mechanism design for prototyping, pre-production & Pilot Production.

ADR Contract: Mechanical Designer, R&D, (Contract Employment):Design of Intra-Aortic Blood Pump Console (IABP). Intra-Aortic Balloon (IAB) design, Balloon Wrapping device design, Packaging, Accessory items (Percutaneous), and Accessory Kit Packaging including Tubing Sets. Design of in-house testing and assembly machinery (i.e.: pneumatics, synchronous motors, mechanisms of various complexity and dynamics, fluid and air pumping apparatus). Creation of parts and assembly drawings using GD & T to ANSI standards.