Manufacturing/Process/Validation Engineer Med Device/Pharmaceutical
Resume:
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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