Technical Writer Medical Device

Kathleen M. Laferriere

* ******* ****, *********, ** 03841 ************@*******.*** 603-***-**** Cell: 603-***-****

OVERVIEW:

As a Technical Writer at Volcano Corporation, write and edit Operator Manuals, Service Manuals, Work Instructions (WI),

and Information for Use (IFU) documentation, Test Procedures, Marketing Brochures, Failure Mode Effects Analysis

(FMEA) and a variety of other documentation. Volcano develops and manufactures guided therapy tools designed to

enhance the diagnosis and treatment of coronary and peripheral vascular disease.

APPLICATIONS, DOCUMENTATION, DATABASES

APPLICATIONS DOCUMENTATION DATABASES

Microsoft Office Suite Information for Use Agile

Microsoft PowerPoint System Manuals Oracle (HTML)

Microsoft Excel Operator Manuals IBM (HR Access)

WinZip/SnagIt/Information Software Specifications Knova – Philips Healthcare

Mapping knowledge database

HTML, Content Management Hardware Specifications Teamcenter Product Lifecycle

Management (PLM)

Adobe FrameMaker/pdf Marketing Brochures/PowerPoint Microsoft SourceSafe

Presentations

EXPERIENCE:

Volcano Corp. Billerica, MA

Sr. Technical Writer March 2011 – Present

Service several organizations within Volcano Corporation including Research and Development supporting both

software and firmware spaces, Engineering Services, and Marketing Communications

• Wrote the Volcano s5i™LVOCT™ Option Operator’s Manual to support the development of Optical

Coherence Tomography (OCT) technology.

• Wrote Information for Use documentation, Systems Manuals, Engineering Support Manuals, Marketing

brochures and presentations.

• Supported Software Development: migrating software requirement documentation from Microsoft Word

format to the Teamcenter Product Lifecycle Management (PLM) database.

• Wrote/updated several Service Manuals and Operators Manuals to support Engineering Services that

include Test Procedures, Work Instructions (WI), Troubleshooting, and Software and Hardware

Specifications.

Aircuity, Inc. Newton, MA

Sr. Technical Writer September 2010 – December 2010

Wrote the 215-page Aircuity OptiNet© Engineering Guide using Microsoft Word 2007

• Obtained all source material from Engineering documents, Design Specifications and drawing packages.

• Created new template, style guide and format.

• Generated cleanly edited, cropped professional photographs and artwork.

• Created Adobe .pdf files for Executive Team review cycles.

Philips Healthcare Andover, MA,

Sr. Technical Writer April 2010 – August 2010

Wrote knowledge-based solutions for medical devices using Knova, Philips Healthcare’s field and factory service

capture application and database. Reviewed, edited and rewrote knowledge-based solutions/procedures that included

Problem Description Details, Problem Cause and Problem Solution blocks

• Provided feedback to 500+ authors worldwide that included product knowledge, procedural writing,

formatting, language, and publishing.

• Tracked writing progress and evaluations using Microsoft Excel spreadsheets. Reports were submitted

weekly to the Program Manager.

• Learned the company product line quickly and was given a company computer setup for telecommuting.

Velaritas, Inc. Shrewsbury, MA

Sr. Technical Writer October 2009 – December 2009

Developed and wrote regulation compliance procedural documentation for medical device manufacturing.

• International Standards: ISO 9001 (ISO 1644-5) Quality Management Systems – Requirements for

Regulatory Purposes, FDA 21 CFR 803, 812, 820, MDD 93/42/EEC, ISO 13485.

• Procedures and Work Instructions included Corrective and Preventive Action (CAPA), Quality

Objectives, Quality Planning, Training, Identification and Traceability, Internal Audit Program, Supplier

Survey, Customer Feedback and others.

• Applied Information Mapping techniques to improve document efficacy.

Gulf Oil Framingham, MA,

Sr. Technical Writer January 2009 – October 2009

Developed and wrote Standard Operating Procedures (SOPs) to support the Gulf Oil Financial Division .

• Implemented document design, format, and style.

• Validated and documented financial processes.

• Documented “how to” steps and navigational paths using SolArc Right Angle (SAR) software and the

TopTech Terminal Authority system.

• Prepared for Bank Audits

Teleflex Medical Everett, MA

Sr. Technical Writer August 2008 – January 2009

Developed and wrote medical device manufacturing procedures from operator interviews and out-of-date Work

Instructions.

• Prepared for FDA Audit.

• Implemented successful elements: Graphic Operator Interface format, process maps, boilerplate

statements and consistent practice and engineering process changes.

BAE Systems, Nashua, NH Nashua, NH

Technical Writer/Editor November 2006 – August 2008

Supported U.S. Air Force – Government Contracts

• Wrote, modified, and enhanced new and existing User Guides, Maintenance Manuals, and Operating and

Test Procedures using Microsoft Office, Adobe Acrobat, and PowerPoint authoring tools.

• Interviewed engineering staff and SMEs to gain product knowledge.

• Used screen captures, photographs, engineering drawings, and schematics to illustrate software display

screens, hardware connections, and signals. Accurately described software interfaces.

• Managed schedules, prepared documentation status reports and prioritized projects to meet engineering

and customer deadlines.

Fidelity Investments, Merrimack, NH Merrimack, NH

Technical Writer/Editor May 2006 – September 2006

Wrote User Procedure Documents (UPDs) necessary to convert data from an Oracle (HRMS) database to an IBM (HR

Access) database

• Communicated with Subject-Matter Experts (SMEs) and business analysts to gather information to ensure

that process step documents, supplemental documents, and attachments were technically correct, and

accurately described how to use the HR Access interface.

• Captured screen shots of various HR Access functionality using SnagIT and other graphics tools.

• Wrote supplemental documents and attachments used in tandem with process steps. These documents

detailed how to perform procedures to complete the process, and are included as Reference Documents

within each step as required.

Lincoln Laboratories

Lexington, MA

Reporting Specialist

October 2005 – April 2006

Supported U.S. Air Force; Satellite Division

• Complied with Lincoln Publications guidelines, templates and their LLDocs database.

• Worked from engineering notes and files, created a Technical Specification that supported a Signal

Processing Motherboard (SPM) test plan and a Signal Processing Daughterboard (SPD) test plan.

• Converted files from Microsoft Word to Adobe FrameMaker, and delivered pdf’s for review.

Cisco Systems

Boxborough, MA

Technical Writer

March 2005 – July 2006

Wrote the Cisco Trust Agent (CTA) Administrator Guide - CTA is a specialized application that runs on the network

from the Network Admission Control (NAC)-compliant applications installed on those clients. CTA then reports the

posture information to a validation server, which provides or denies access to the network.

Winter, Wyman & Company

Waltham, MA

Technical Writer

October 2002 – November 2003

Provided editorial support to NIIT Systems in New Delhi, India for SkillSoft

Lightchip Optical Networking

Salem, NH

Technical Writer

March 2001 – April 2002

Using Adobe FrameMaker, wrote the Optical Wavelength Manager (OWM) System User Guide used for monitoring,

configuring and managing Dense Wavelength Division Multiplexing (DWDM) networks .

• Prepared documentation plans and managed schedules to support product deliverables.

• Tested and documented the hardware equipment and the software features through the Command Line

Interface (CLI) and the Graphical User Interface (GUI) in an API environment.

• Wrote and produced the Cisco Systems version (ONS 15216 OPM).

• Used Microsoft SourceSafe library to store Engineering and customer files.

• Created document templates used for customer projects.

• Converted files from Microsoft Word to documentation source files in FrameMaker. Engineering

documents included the OWM Command Line Interface, the OWM GUI, OWM Boot Loader, OWM

Spectrometer CLI and Spectrometer Boot CLI, OWR Command Line Interface, Device Descriptors, LC

485 Protocol, and Cisco Systems final test specifications.

• Reported CLI and GUI errors to a program used for bug tracking.

• Resolved documentation bugs for the OWM and OWR User’s Guides.

OrderTrust, Inc Lowell, MA

Technical Writer March 2002 – December 2002

Wrote and created Software Development Kits (SDKs) to support proprietary eCommerce software .

• Wrote pre-sales documentation and proposals used to support Sales and Marketing.

• Wrote and maintained online Technical Reference Manual (TRM) documentation .

Cabletron Systems Andover, MA

Technical Writer August 1999 – March 2000

Wrote pre-sales documentation and proposals used to support Sales and Marketing.

• Wrote HTML Help Systems for router Embedded Device Management.

• Wrote an HTML Help System using FrontPage Editor for Java applications.

• Wrote several Hardware Installation Manuals, User’s Guides, and sets of Release Notes

EDUCATION

• University of Massachusetts, Lowell, (65 Hours of Course Work) 1994 - 1995

• Hesser College (48 Hours of Technical Course Work) 1983 - 1986

• New Horizons Computer Center – received several certificates of completion: Illustrator 9, PowerPoint.

Flash 5, HTML, Photoshop, Dreamweaver, Project Management Fundamentals, QuarkXPress, Level l

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