T O M A B B O T T

M E C H A N I C A L E N G I N E E R I N G D E S I G N E R /D O C U M E N T C O N T R O L S P E C I A L I S T

Bringing 15+ years of experience in 3D modeling in the life sciences and semiconductor industry and 25+ years working in high tech engineering. Background includes extensive experience in documentation, mechanical design engineering and drafting, quality control and internal and external audits as required by the FDA, ISO and RoHS product safety initiative.

T E C H N I C A L P R O F I C I E N C I E S

Solid Edge ST5, ST6, ST7 Design Platforms SAP Data Management System 2016 SolidWorks Office Professional 2007 to 2013 SolidWorks PDM Engineering Data Management System Agile 2013 MRP and ERP System Microsoft Office Suite Word, PowerPoint, Visio, Excel, Outlook Insight Solid Edge File Management System Grand Avenue Software Document Control System Infor MRP/ERP Data Management System Globalshop Data Management System Unigraphics V18, NX1, NX2, NX3, 3D Design Platforms Iman V7.0, V9.0 MRP/ERP Data Management System Teamcenter V.1.2.0 Product Lifecycle Management System Pro-E 3D Solid Modeling Design and Drafting Intralink Data Management System AutoCAD Versions 2000, 2002. 2008 2D Adobe Acrobat 5.0 GD&T Geometric Drafting & Tolerancing per ANSI Y14.5

T E C H N I C A L C O N T R I B U T I O N S

Document preparation and control as required for FDA, ISO and RoHS Compliance. Administration of quality system and change process (DCO/DCR) under FDA Quality System Regulation

(QSR), Title 21 CFR part 11 and ISO 13485. Creation and quality control of mechanical layouts, assemblies, details and bills of material. ECR control and disposition using SAP, Infor and Iman platforms, among others. Designed and built special purpose fixtures to facilitate manufacturing. Source and in-house inspection and analysis. 3D solid modeling for mechanical design and analysis. Product testing, creation of test reports and recommendations. Creation of new product testing and installation procedures. New design development. Creation of supplier specifications. Management of mechanical design/drafting group (FEI Co., Peabody MA).

P R O F E S S I O N A L E X P E R I E N C E

BRUKER DALTONICS, Billerica MA 2013 – Present

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Document Control Specialist, Mechanical Designer

Engineering Team member working directly with Engineering, Planning and Manufacturing personnel. Exercising control the document change process affecting Engineering and Quality Documents under FDA

Quality System Regulation (QSR), Title 21 CFR part 11 and ISO 13485, Bills of Resources, SOP's and Work Instructions and all related work product.

Administrating ECR/ECN packages from inception to implementation, including the review of all Engineering Change documents to ensure accuracy and clarity, document revision archive maintenance, updating and revising engineering drawings using Solid Edge, updating various manufacturing documentation such as Work Instructions and Manuals using Solid Edge, Word or Excel, maintenance of informational accuracy, clarity and consistency between the Engineering, Planning and Manufacturing groups in the ERP system, part number creation, other duties as required.

Certificate for Solid Edge ST5 Fundamentals, certification achieved in 02/2014. Certificate for Quality System Registration Good Documentation Practice, certification achieved in 04/2015. Certificate for QSR Design Control 21 CFR 820.30 Training, certification achieved in 01/2015.

CANDELA CORPORATION, Wayland MA 2012 – 2013

Document Control Specialist, Mechanical Designer (Contract Position)

Contracted to assist both Document Management and Engineering Design Groups in a fast paced medical device environment.

Executed the successful changeover to the Agile (Oracle) based data management system including assignment of part numbers, ECO generation, logging and controlling attached documents in SAP, assignment of signatories in the workflow, and quality control of all controlled document products.

Supported the Engineering Group with the creation of detail and assembly revisions, drawings, and BOM updates.

SPIRE CORPORATION, Bedford MA 2008 – 2012

Mechanical Designer/Document Quality Control Specialist

Managed SolidWorks PDM for the engineering group in Bedford. Performed quality control and review of all mechanical drafting products created by the engineering group.

This includes documentation for new and prototype systems as well as the review of drawings, BOMs and SOPs being sent through the DCO system.

Created and implemented a document naming standard to aid in database searches. Held regular meetings with both the Manufacturing managers and outside vendors in an effort to update and

revise out of date or faulty documents. Performed both mechanical and architectural design and drafting documents using both SolidWorks and

AutoCAD.

GSI GROUP INC, Bedford MA 2006 – 2008

Principal Mechanical Designer

Worked with senior engineers to create 3d models and drawings of individual parts and structured assemblies using SolidWorks.

Investigated mechanical design issues for new products, including the creation of reports, PowerPoint presentations and all supporting documentation.

Generated, executed and closed ECO documentation for BOMs, Drawings and Work Instructions. Created Purchase Specifications for outside vendors and was the designated contact person to answer

engineering questions.

FEI COMPANY, Peabody MA 2001 – 2005

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Senior Mechanical Designer, Group Leader

Designed a wide variety of mechanical layouts and assemblies while working closely with project managers, vendors, and suppliers.

Created designs and support documentation for laser alignment and targeting, reticle handling and stage operations, high vacuum pump and chamber testing, gas delivery systems, motion control and stage development, electronics cabinets, user interface design, and overall tool aesthetics.

Led a group of designers and drafters in a successful effort to upgrade and complete documentation for two of FEI's most visible product lines (Accura XT Reticle System and CLM 300mm Wafer System). The focus of this group was the creation and release of assembly and detail drawings, bills of material, product specifications and installation procedures (under strict deadlines) and transfer this documentation to our new manufacturing facility in Oregon.

AXCELIS CORPORATION, Beverly MA 1995 – 2001

Mechanical Designer/Drafter

Created designs for the development of the High Energy (HE) and Low Energy/High Current (LE) 300mm multi-wafer platform groups.

Generated solid models in Pro-E for design analysis and review. Created and released details, assemblies and bills of material for these products. Supported for a wide variety of tasks such as mini-environment design, vacuum chamber and related in-

vacuum devices design, and custom rack design for proprietary electronic equipment.

E D U C A T I O N A N D T R A I N I N G

Candidate, Bachelor of Science, Business Management, LESLEY UNIVERSITY , Cambridge MA (expected 2017)

LMGi Training Program, Bruker Corporation, Billerica MA. (2014)

Caddedge SolidWorks Training Center, Peabody MA (2006)

UGS Unigraphics Training Center, Waltham MA (2002)

PTC Pro-Engineer Training Program, Axcelis Corporation, Beverly MA (1999)

GD&T Y14.5 Training Program, Gloucester Engineering, Gloucester MA (1986)

Certificate, ITT Technical Institute, Chelsea MA (1984)

P E R S O N A L I N T E R E S T S

Music, Writing, Art, and the Theater,