A Skilled Project/Process/Manufacturing Engineer with extensive experience in new product development through production release. Areas of expertise include design for manufacturability, Process Validations, GMP, tooling, fixtures, and component specifications, WI’s, DOE’s, LEAN manufacturing, SOP’s for clean-room semi-conductor industry and Ion-implantation, manufacture of medical devices, optical devices, electronics, high-precision custom machinery, and mil-spec aerospace Turbine Engine machining.

T2 Biosystems Inc, Lexington, MA 2015-2016

Sr. Manufacturing Engineer Reagent Manufacturing

Production development for the release and FDA approval for manufacture of Blood Analyzing Chemical Assays.

Process Development, validation, IQ/OQ/PQ

Production equipment specification installation and validation.

Installation and validation of class 5 and 8 clean rooms

Manage redesign projects and work closely with vendors, on quality issues, including site inspections

Develop Fixtures, process ECO’s, WI’s SOP’s, BOM’s

DEKA Research and Development, Manchester, NH 2012-2015

Sr. NPI Manufacturing Engineer, MFG Group Leader

Coordination of R & D and all aspects of production development for the release and FDA approval for manufacture of multi-configurable robotic prosthetic arms.

Manufacturing Department Lead

Production scheduling, personnel resource planning, materials coordination

Project planning and coordination within departments.

ECO’s, RMA’s, Anomaly’s, Inspections, Process improvements

Operation procedure writing and personnel training

Fixture conceptualization and design

Implementation of PLM Software program (Arena Solutions)

INSULET CORPORATION, Bedford, MA 2012 (11 mo. contract)

NPI Manufacturing Engineer

Develop and modify processes, procedures, documents, assembly fixtures for the release of wearable, disposable, drug delivery devices regulated under ISO 13485:2003.

Develop and process pre-production IQ/OQ/PQ’s for production equipment

Develop and document procedures for medical device equipment assembly and test

Process EC’s and release part specifications, drawings, and documents

BOM creation, modification including process routing

PHILIPS MEDICAL SYSTEMS, Patient Monitoring Division, Andover, MA 2007-2011

Manufacturing Engineer / Materials Engineer

Develop and modify processes, procedures and documents for the release of Medical Patient Monitoring Device Systems under ISO 13485.2003. Initiate and process QN’s, SCN’s and SCAR’s.

Develop and process pre-production IQ/OQ/PQ’s for production equipment

Develop and document procedures for medical device equipment assembly and test

Process EC’s and release part specifications, drawings, and documents

BOM creation, modification including process routing

Process Discrepant Material Disposition

SAINT-GOBAIN PERFORMANCE PLASTICS, Merrimack, NH 2004-2006

Sr. Manufacturing Process Engineer

Develop and design LEAN processes and procedures and equipment and support Internal and External Manufacturing efforts using Six Sigma techniques for the release of chemical resistant protective suits and gloves for military and civilian use, military chemical/biological protective shelter structures, and microwave invisible antenna enclosure systems (Radomes).

Develop, design and improve production processes utilizing D/PFMEA’s and test plans

Implement products and processes transition from prototype to full production

Identify Special production equipment specification, design, test, verification.

BOM creation, including process routing (QAD)

Assembly Floor Layout

Capital Expenditure Analysis, material quote analysis, spend tracking

Custom design machine specification, work with design companies manufacturing machinery for, general design, detail specification, safety conformity, through Validation

Process flow creation, diagrams, Line balancing, work instructions and personnel training

Manufacturing Cost analysis

Design print review and acceptance for Manufacturing ECO Review

UTC / PRATT & WHITNEY (BELCAN ENGINEERING) North Berwick, ME 2001-2004

Project Engineer

Coordinate multiple concurring engineering projects for the design and manufacture of military and commercial gas turbine jet engines and products.

Lead/ Support Integrated Product teams for development and production hardware

Coordinate between vendors, engineering, and manufacturing

EC writing, planning and implementation

Informational research and compiling

Presentation development, planning and participation

Cost analysis

AVICI SYSTEMS INC. North Billerica, MA 1999-2001

Process/Manufacturing Engineer

Develop and coordinate highly scalable manufacturing outsourcing procedures for purpose built carrier-class switcher/routers for the Internet.

Design and review for manufacturability

Assembly and test procedures and training

Liaison to contract manufacturers and vendors

Resolve Quality control issues, Process SCAR’s

Resolve assembly and materials issues

Process flow and floor-plan layout

DEHAART TECHNOLOGIES INC. Burlington, MA 1996 1999

Process/Manufacturing Engineer, Technical Sales, Product Manager

Develop and produce new products, organizing and coordinating with all departments covering all aspects of development from conceptualization, R&D, production, sales of highly accurate and reliable Stencil Printers for PCB manufacture.

Product Specification, Development and Layout

Design review, Design for manufacturability

Tooling and assembly fixtures

Parts Specification and cost analysis with suppliers and vendors

Production preparation and Documentation Control

Procedures, assembly and testing, Inspection and Final Q.C.

Technical sales (In-house and trade shows) and Customer Support

GROTON TECHNOLOGY, GTI/SPECTROVISION Acton, MA 1990 1996

Assistant Manufacturing Manager/ Electro-Mechanical Designer/Assy + Test Tech

Design, develop and manufacture new and existing products collaborating with engineering and production to improve product and reduce cost on UV/Visible HPLC Fluorescence Spectrometers and Diode array chemical detectors. Implemented the ISO 9000 certification process.

Product Design and Development from conceptualization through production

Mechanical, optical and Electrical Design and Layout

Doc Control and Drafting

Work Scheduling

Inventory Control

Assembly, Test, Final QC.

EDUCATION

University of Massachusetts, Lowell, CAD Certificate program 2006

Northern Essex Community College, Haverhill, MA, CAD Certificate (Cadkey) 1996

BS in Management Science, Bridgewater State College, Bridgewater, MA 1990

Bachelor of Engineering Technology (BET) Program, Northeastern University 1981-82

CERTIFICATIONS/QUALIFICATIONS

CPR certified, MSA Scott Air-Pac Rescue Apparatus certified,

Windows, MS Office, SAP, Act!, Q&A, JD Edwards-Agile, AutoCAD, SolidWorks, QAD.

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