Mr. Tracy S. Gulick

Work Experience At-A-Glance

Project Manager Jan 2014 to July 2014

Greatbatch Medical Ft. Wayne, IN

Principle Quality Engineer July 2013 to Nov. 2013

Omnyx, LLC. Pittsburgh, PA

Software Quality Engineer Oct. 2012 to Oct. 2013

Dentsply International Tulsa, OK

Senior Product Quality Engineer April 2011 to Sept. 2012

Jabil Circuit St. Petersburg, FL

Process Quality Engineer Oct. 2010 to March 2011

Stryker Instruments Kalamazoo, MI

Software Quality Engineer II April 2010 to Sept. 2010

Baxa Corporation Daytona Beach, FL

Senior Compliance Engineer July 2008 to Feb. 2010

Sparton Medical Systems De Leon Springs, FL

Systems Integration Engineer June 2007 to July 2008

LipoScience Incorporated Raleigh, NC

Product Assurance Validation Engineer Apr. 2007 to June 2007

Respironics, Inc. Murrysville, PA

Principle V&V Engineer Oct. 2006 to Jan. 2007

Baxter Healthcare Pinellas Park, FL

Senior Validation Engineer Apr. 2006 to Sept. 2006

Defibtech, LLC Guilford, CT

Software Quality Engineer Nov. 2005 to Feb. 2006

Terumo Heart, Inc. Ann Arbor, MI

Product Development Manager 1997 to Nov. 2004

International Technical Service Manager 1997 to Nov. 2004

Technical Service Manager 1996 to 1997

Technical Service Engineer Oct. 1993 to 1996

Primus Corporation Kansas City, MO

Food Chemist 1987 to 1993

Armour and Company Kansas City, MO

Education

Kansas State University Manhattan, KS 1986 to 1987

• Twenty-three Graduate hours towards a Master of Science degree in inorganic chemistry.

• Member of Α ΧΣ Professional Chemistry Fraternity.

Dakota State University Madison, SD 1982 to 1986

• Bachelor of Science degree. Math, chemistry and physics composite degree.

Mr. Tracy S. Gulick

• Honors: American Institute of Chemists’ Outstanding Chemist Award, Three scholarships,

University and National Dean’s Lists, Student Body President, and Outstanding Senator & Rookie

Senator of the YearDetailed Work Experience

Greatbatch Medical Ft. Wayne, IN Jan 2014 to July 2014

Project M anager

1 Contract employee hired to provide management of other contract employees and act as a liaison

to company management.

2 DHR remediation, CAPA remediation, and process validation.

3 Write software to facilitate remediation efforts.

Omnyx, LLC. Pittsburgh, PA July 2013 to Nov. 2013

P r inciple Qua l ity Engineer

4 Contract employee hired to provide additional QE support for a Class III Digital Pathology systems;

4-slide scanner, 120-slide scanner, Pathologist Workstation, and Histology Workstation.

5 Review and approval of hardware drawings.

6 Software quality support for feature development in Workstation software – in particular, HL7, PACS,

and DICOM standardization in an Agile development environment.

7 Updating SOPs for controlled software and hardware development and validation for adherence to

IEC 62304, 21 CFR 820, and 21 CFR 11.

Dentsply International Tulsa, OK Oct. 2012 to Oct. 2013

Softwa re Qua l ity Engineer

Contract employee hired to validate software for new dental laser.

1

Validation Plans, Requirements documents, Test Protocols, and Validation documents.

2

Unit, integration, and functional testing.

3

Writing divisional SOPs for software development and validation for adherence to IEC 62304.

4

Jabil Circuit St. Petersburg, FL April 2011 to Sept. 2012

Senior Product Qual ity Engineer

1 Permanent employee hired to bring the company in compliance with IEC 62304, 21 CFR 820,

21 CFR 11, ISO 13485, and ISO 14971 regulations.

2 SOPs, Validation Plans, Requirements documents, Test Protocols, and Validation documents.

3 Risk management and DFMEAs.

4 Originate and maintain DHFs for contracted product design.

5 Requisite Pro requirement tool system administrator.

Stryker Instruments Kalamazoo, MI Oct. 2010 to March 2011

Process Qual ity Engineer

5 Contract employee hired to validate portions of new product production line.

6 IQ, OQ, and PQ.

7 Design and validation of three automated production stations.

Baxa Corporation Daytona Beach, FL April 2010 to Sept. 2010

Softwa re Qua l ity Engineer I I

8 Contract employee hired to bring software testing into compliance with parent company.

9 Validation Plans, Requirements documents, Test Protocols, and Validation documents.

10 Software testing and implementation of automated testing using SmartBear’s TestComplete.

Sparton Medical Systems De Leon Springs, FL July 2008 to Feb. 2010

Senior Compliance Engineer

Mr. Tracy S. Gulick

11 Full-time employee hired to ensure adherence to 21 CFR 820, 21 CFR 801, 21 CFR 11, ISO

13485, and ISO 14971 regulations and guidelines for several contracted Class II & III medical

devices.

12 Validation Plans, Requirements documents, Test Protocols, and Validation documents.

13 Risk management, maintain DHF, and Engineering Change Order management.

14 Software coding for automated test tools using Microsoft’s Visual Basic, Visual C++, and Visual C#.

15 Black box and white box testing.

Mr. Tracy S. Gulick

Detailed Work Experience - Continued

LipoScience Incorporated Raleigh, NC June 2007 to July 2008

Systems I ntegration Engineer

1 Full-time employee hired to ensure adherence to 21 CFR 820, 21 CFR 801, 21 CFR 809, 21 CFR

11, ISO 13485, and ISO 14971 regulations and guidelines for a Class II IVD medical device.

2 Write SOPs, Requirements documents, Test Protocols and Validation documents.

3 Software coding for test tools using Microsoft’s Visual Basic, Visual C++ (MFC), and Visual C#

(WPF).

4 Risk management and Engineering Change Order management.

5 Good Automated Manufacturing Practice validation.

6 Originate and maintain DHF.

7 Hardware and software re-engineering of fluidics sub-system in Microsoft Visual C# (WPF).

8 Independent Reviewer of software validation for 510(k) submission.

9 Black box, gray box and white box testing.

Respironics, Inc. Murrysville, PA Apr. 2007 to June 2007

Product Assurance Validation Engineer

10 Contract employee hired to ensure product validation adherence to FDA and ISO 13485 regulations

and guidelines for a Class II & III, medical devices.

11 Write new medical device test protocols and test cases for Product Assurance.

12 Organization of testing using HP QuickTest Professional.

13 Software requirements analysis and traceability using Telelogic DOORS.

14 Black box testing.

Baxter Healthcare Pinellas Park, FL Oct. 2006 to Jan. 2007

P r inciple V &V Engineer

15 Contract employee hired to ensure software validation adherence to FDA and ISO 13485

regulations and guidelines for a Class III, Automatic Peritoneal Dialysis machine.

16 Use Case and Test Case writer for new product development.

17 Software requirements analysis and traceability using Telelogic DOORS.

Defibtech, LLC Guilford, CT Apr. 2006 to Sept. 2006

Senior Validation Engineer

18 Contract employee hired to ensure validation adherence to FDA and ISO 13485 regulations and

guidelines for a Class III, portable Automated External Defibrillator.

19 IQ/OQ/PQ process development for hardware Test Fixtures.

20 Good Automated Manufacturing Practice validation.

21 CAPA remediation and FDA Warning Letter, form 483, remediation

22 Write new medical device test protocols.

23 Generate validation reports, which include summaries and rationales for deviations. Make

recommendations for resolution of non-conforming material.

24 Software requirements analysis and traceability using Telelogic DOORS.

25 Quality System auditing.

Terumo Heart, Inc. Ann Arbor, MI Nov. 2005 to Feb. 2006

Softwa re Qua l ity Engineer

26 Contract employee hired to ensure software validation adherence to FDA and ISO 13485

regulations and guidelines for a Class III, Implantable Left Ventricular Assist System.

27 Quality Engineer overseeing Software Test Case development, execution, and reporting. Ensuring

proper traceability back to software and device specifications. Using Seapine’s Test Track Pro and

IBM’s Rational RequisitePro to direct ECOs for code changes and selection of Regression Test

Cases to ensure proper coverage of noncompliant source code.

Mr. Tracy S. Gulick

28 “White Box” testing at the electronic board level and “Black Box” testing pre-production devices using

DVM, oscilloscope, temperature probes, and specially adapted equipment.

29 Code reviewer and Test Engineer of embedded software for XA and DSP chipsets.

30 IQ/OQ process development for hardware Test Fixtures.

Mr. Tracy S. Gulick

Detailed Work Experience - Continued

Primus Corporation Kansas City, MO Oct. 1993 to Nov. 2004

1997 to 2004

Product Development M an ager

1997 to 2004

I nternational Technical Service M an ager

1996 to 1997

Technical Service M an ager

1993 to 1996

Technical Service Engineer

Full-time employee. Manager of new product development and current product upgrade. This

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includes the mechanical and software development and Validation Needs Manager on new products

with regards to 510(k) application, software and hardware verification/validation. Also included mid to

high-level electronic application and implementation.

Sole staff programmer for company’s instrument and robotics software. Responsible for complete

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software life-cycle of architecture design, coding, verification, validation and implementation.

Programming in Pascal and Microsoft’s Visual C++. Experience with embedded C software.

Programming experience with interface to Laboratory Information Systems using ASTM protocols.

Programming experience working with proprietary database systems.

Revise existing and write new medical device test protocols.

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QC testing and QC reviewer/approver of buffers, reagents, calibration material and control material.

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Directing, training, and mentoring engineering technicians to accomplish device testing.

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Generate validation reports, which include summaries and rationales for deviations. Make

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recommendations for resolution of non-conforming material.

Quality Engineer for software, hardware, and production processes. Develop and execute SOPs and

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IQ/OQ/PQ for many of the processes. Implementation and training of GLP and GMP.

Implementation of 21 CFR 820 Quality Systems.

Eleven years of experience in all levels of software validation: Module, integration, white box, and

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black box. Development of proprietary automated validation tools.

Development and validation of production processes.

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Manage the Domestic and International Technical Service departments’ resources. Schedule repair

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and maintenance, training of clients and oversee instrument quality control and shipping.

510(k) submission co-author.

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Black box, gray box and white box testing.

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Up to 10% International travel and 50% domestic travel.

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Armour and Company Kansas City, MO 1987 to 1993

Food Chemist

Full-time employee.

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Analysis for raw material and finished product for compliance to USDA regulations.

45

Hazard Analysis & Critical Control Points (HACCP) manager.

46

Software programmer for QA department.

47

Volunteer Work

Bikers Against Drunk Drivers Ormond Beach, FL 2009 to Aug. 2010

(B.A.D.D.)

Programmer / Website M anager

48 Set-up of new webcam at Bruce Rossmeyer Destination Daytona, B.A.D.D. World Headquarters.

49 Development of custom membership database software in Microsoft’s Visual C# (WPF / Access ADO

database).

50 Maintenance and upkeep of B.A.D.D. website – C#, ASP.net, Access ADO database.

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