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Medical Device Project Manager

Location:
Minneapolis, MN, 55410
Posted:
October 31, 2010

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Resume:

Doug Clapp

**** **** ****** *****, *****, MN ****0

abif0q@r.postjobfree.com

952-***-****

Executive Summary

Experienced professional with high-level skills in technical writing,

project management and website, hardware and software development.

Technical Competencies & Certifications.

Development environments: Microsoft .NET and MS-SQL. Microsoft Access. IBM

Rational Clearcase. Adobe Robohelp. UML (Universal Modeling Language); XML.

Applications: Adobe Acrobat, Framemaker, Indesign and Photoshop. Microsoft

Office: Project, Word, Excel, PowerPoint and Visio. Microsoft SharePoint.

Telelogic DOORS. Doxygen. Lotus Notes.

OS: Windows, Macintosh OS and Unix/Linux.

Certifications: Dell EA Certified Server Specialist

Professional Experience

Boston Scientific Corporation- BSX; Medical device

manufacturer

Minnetonka, MN

Contract Technical Writer; 5/2010 to present

Currently on a contract to create and update Clinical IS documentation.

American Medical Systems - AMMD; Medical device manufacturer

Minnetonka, MN

Contract Senior Regulatory Technical Writer; 1/2010 to 5/2010

. Prepared 100+ regulatory documents for European Union medical device

submission.

. Created served-based multi-user interactive 45-sheet Excel workbook

for all AMS product revenue and FTE projections; used as primary

forecasting tool by AMS.

MFG Solutions - Medical / consumer device manufacturer

South St. Paul, MN

Senior Regulatory Technical Writer; 2/2009 to present

. Designed and wrote medical regulatory documents, user manuals,

regulatory documents, industry white papers and website copy for

medical devices and consumer electronic products. Used Adobe

Framemaker and Microsoft Word 2007

Davenport Group - Storage device reseller

Saint Paul, MN

Consultant ; 6/2008 to 2/2009

. Provided IT consulting and project management for clients of the

Davenport Group, a technology consultant and reseller offering storage

area network, thin replication, disaster recovery, virtualization and

other products to large corporate customers.

St. Jude Medical - Medical device manufacturer

Saint Paul, MN

Contract Regulatory Technical Writer; 3/2008 - 4/2008

. Revised and updated a sophisticated manual for a new software revision

of a real-time catheter system. Used Adobe Framemaker, worked with

full color images.

. Worked closely with St. Jude regulatory department.

. Collaborated with engineers, medical device specialists and other

subject matter experts. Learned and followed federal guidelines

required for document approval.

MedGraphics - Medical device manufacturer (a division of Angeion)

Saint Paul, MN

Contract Technical Writer; 10/2007 - 3/2008

. Revised, updated and corrected operations and service manuals for

respiratory medical devices prior to shipment of new products.

. Reformatted sales collateral using Adobe InDesign. Created help

systems using Adobe RoboHelp.

Verifications, Inc - Global provider of background screening, drug testing

and applicant processing

Maple Grove, MN

Contractor; 3/2007 - 10/2007

. Designed website architecture and development for complex user

interface

. Provided Product Project Management on multiple projects

. Managed architecture and development of "VIAM Talent Portal":

integrated applicant tracking and background investigation software-as-

service (SAS) website. Managed matrix development environment among

three companies: Verifications, ImageTrend (developers) and eCra

(design firm).

. Researched and wrote complex business plans for new product offerings.

Hill-Rom - Medical device manufacturer (A division of Hillenbrand, Inc.; a

NYSE company)

Saint Paul, MN

Contract Technical Writer; 11/2006 - 3/2007

. Created programmer and end-user documentation for "NaviCare Bed

Manager," a SQL-server based software application used by hospitals to

trace and manage patient flow.

. Worked with IBM Rational Clearcase; Doxygen (auto-documentation

software), Telelogic Doors (use case creation software), Adobe

Framemaker, Microsoft Access, Microsoft SQL Server 2005, and Microsoft

Visual Studio 2005 (C

. Completed Hill-Rom training on Clearcase and Doors.

Previstar; (then) RAMSAFE Technologies, Inc.

Arlington, VA

Contract Project Manager - Senior Program Manager; 2005 - 2006

(RAMSAFE - an acronym for "Responder Assets Management and Situational

Awareness for Emergencies" - is incident management software for Public

Safety, Public Health and Emergency Management agencies.)

Assigned to the New Orleans Emergency Operations Center (EOC), where

RAMSAFE was used to store and process all New Orleans FEMA Project

Worksheets (federal funding requests) related to hurricane Katrina.

. Managed SQL database and related applications that processed a weekly

flow of 150 million dollars in requests.

. Promoted to Project owner of the RAMSAFE New Orleans project in

January 2006.

. Promoted by RAMSAFE to senior program manager in April 2006.

PocketPCpress - eBook publisher

Edina, MN

Founder and President; 2000-2005

. Selected, edited and formatted over 400 eBook titles.

. Put in place national and international distribution channels.

. Negotiated and collaborated with top literary agents and leading

university presses and publishers to create a list of compelling

original fiction and nonfiction.

. Founding publisher in Amazon's eBook section.

Sold business in 2005 to Walking Lion Press, Salt Lake City, UT.

Classaction.com, LLC - Client aggregation website/service serving legal

industry

Minneapolis, MN

Co-founder; 2001 - 2003

. Provided all start-up capital.

. Created concept and developed business model.

Sold interest to co-founders in 2003.

Business consulting

1998 - 1999

Department of Defense (DOD) government consulting.

RSI Systems, Inc. - Videoconferencing hardware/software developer

Minneapolis, MN

Founder, Executive Vice-President and CTO; 1994 - 1998

. Acquired the ongoing software project from VideoLabs (see below),

retained my key programmer and founded RSI Systems.

. Managed both the software and hardware development of the

videoconferencing system.

. Successfully initiated, fostered and concluded a major marketing

agreement with Canon, Inc. for sale of the system to the Japanese

market. During that process, I frequently visited Canon in Japan and

still retain a slight bit of Japanese language fluency.

. Set up European distribution and U.K. technology partnerships.

Instrumental in RSI's successful NASDAQ Initial Public Offering in

1994.

Offshore software development (India)

1997 - 1998

Created, designed and managed development of a software-only

videoconferencing system.

. Successfully recruited, hired and managed a highly talented group of

programmers located in Chennai, India.

. Managed an overseas software development processes in India meeting

deadlines and providing deliverables on time and within budget.

The project was completed, but failed to gain funding for a major U.S.

release because of competition from Microsoft. The application was sold to

the Indian developers and it is now a best-of-class product in India.

VideoLabs, Inc. - Videoconferencing and PC-based camera developer

Minneapolis, MN

Founder, Vice-President & CTO; 1990 - 1994

Founded company to develop and market a high-quality, affordable, multi-

platform desktop videoconferencing system.

. Designed, and received two patents for the "FlexCam Desktop Video

Camera," which remains a popular product. VideoLabs had a successful

NASDAQ Small Market Initial Public Offering, and was subsequently

taken over by another communications-related company.

. Led industrial design team to create award-winning functional camera

design.

. Created European sales distribution network.

. Created all marketing collateral.

Multi-Ad Systems, Inc.

Minneapolis, MN

Director of Product Development

Director of International Marketing; 1988 - 1990

The desktop publishing application developed by Foundation publishing (see

below), just prior to shipping, was purchased by Multi-Ad Services of

Peoria, IL; a (then) 32 million dollar privately-held corporation which

provides advertising artwork and software to the newspaper industry. Along

with the sale of the product, I joined Multi-Ad services to head continuing

development and marketing of the product. That application, "Multi-Ad

Creator" is now used at major newspapers around the world, including The

New York Daily News, The Chicago Tribune, Minneapolis Star Tribune, San

Francisco Examiner, and many more.

. Created and staffed a 24/7 eight-person help desk center.

. Designed and programmed the technical help / customer support

database.

. Wrote and designed all product documentation.

. Set-up European distribution for the product and led product

localization to translate the application and documentation into

French, German, Italian and (really) Icelandic.

Foundation Publishing, Inc.

Minneapolis, MN

Founder & President; 1985 - 1988

Conceived, designed and managed the development of a large, complex desktop

publishing application for the newspaper industry - an application designed

to compete directly with Aldus PageMaker and Quark XPress. During

development, created lasting relationships and friendships with top

management at the Knight-Ridder newspaper chain.

Apple Computer

Cupertino, CA

Visiting Journalist; 1983 - 1984

. Invited as one of only two journalists to intimately observe and

document the creation of the Apple Macintosh.

. Spent most of 1984 at Apple in Cupertino learning about all aspects of

computer software and hardware development and computer product

marketing.

Freelance writer

Freelance technology writer. InfoWorld columnist. Founding MacUser

columnist. Lecturer. Wrote hundreds of computer-related articles, published

in various computer magazines. Named one of "The Ten Most Important

Macintosh People" (Softalk Magazine) and one of the "100 Most Influential

People in Personal Computing" (ComputerWorld).

Education & Military

University of Minnesota, Morris

University of Minnesota, Minneapolis

U.S. Coast Guard,

Electronics Technician training. Honorable discharge

Patents, books and productions

Patents:

6,654,825, 6,519,662, 6,397,275, 6,073,192, 6,073,192

Peripheral video conferencing system with control unit for adjusting the

transmission bandwidth of the communication channel

D375, 319

Tabletop video camera

Books:

1992 - The Macintosh Reader (Trade paperback). Published by Random House;

Book-of-the-Month club selection in May 1992.

1990 - The Next Bible: Hardware & Software Systems for the NeXT Computer

(Trade paperback). Published by Brady Publishing.

1986 - Doug Clapp's Word Tools (Commercial Macintosh software application)

Specified, designed and oversaw development of "Doug Clapp's Word Tools,"

the first spelling and grammar checker for the Apple Macintosh. The product

was published and marketed by Aegis Productions.

1986 - Doug Clapp's Jazz Book: The Quintessential Guide to Mastering Jazz

on Your Macintosh (Trade paperback). Published by Scott Foresman & Company.

1985 - The Complete Macintosh Sourcebook (Trade paperback)

Co-authored with Pat Ryall. Published by Publishers Group West.

1984 - Macintosh: Complete! (Trade paperback). Published by Softalk

Publishing.

Software: Doug Clapp's Word Tools; Multi-Ad Creator

Websites: Classaction.com; VIAM Applicant Management.

Professional network: Linkedin.com

References: Recommendations can be found on LinkedIn. Recommenders may be

contacted, if desired.



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