Software Verification and Validation

KIMBERLY M. MAHAR

*** ******** ******

Schenectady, NY 12305

518-***-**** ext. 323

OBJECTIVE A position utilizing my software skills

EDUCATION

SUNY College at Fredonia; Fredonia, New York

Bachelor of Science Degree, December 1995

Major: Biomedical Research Technology

SUNY College at Morrisville; Morrisville, New York

Associate in Applied Science Degree, May 1993

Major: Medical Laboratory Technology

EXPERIENCE

03/2008 – Present: Research Assistant; City Mission of Schenectady; Schenectady, New York

Create Service Resource Provider Book

09/2008-09/2008: Independant Consultant; Software Engineer

Website testing

08/1999 – 07/2007: SOFTWARE VERIFICATION/VALIDATION; Johnson and Johnson; Research and Development; Ortho Clinical Diagnostics; Rochester, New York

Experience throughout software lifecycle for Medical Devices following FDA guidelines

Work with Laboratory Information System vendors with ASTM Specifications

Assist Customer Technical Support when necessary

Represent Product Support Software Verification/Validation in multi-functional team meetings

Participate with FDA 510(k) regulatory submissions

Review and approve design requirement specifications

Define appropriate project plans and schedules

Develop test procedures/test cases and test tools

Lead verification/validation test teams

Communicate to project and test teams

Identify/create test data to thoroughly test requirements

Manual testing of test procedures/cases

Document findings in log and test procedure log books

Investigate discrepancies found

Submit and maintain defect reports using PVCS-Tracker defect tracking system

Perform traceability using Microsoft Word, Microsoft Access, and Rational Requisite Pro

Document project test results for review and approval of software release

Present test results to project team for review and approval

Submit test plans, procedures, test data and final reports to Document Resource Center

Release software from developmental phase

Knowledge in C++, Sequel, Unix and Qnix

Programming courses taken in Visual Basic, JavaScript, Sequel, Unix

Ability to learn new things quickly

Product support experience in Immunohematology (Ortho ProVue), Immunodiagnostics (Vitros ECi), Transfusion Medicine (OSS), Clinical Chemistry (Vitros FS 5,1, 250, 950, 500/550/700/750)

05/2001 – 07/2001: Software Engineer; Spherion; Rochester, New York

Website testing for online training courses

08/1997 - 06/1999: MEDICAL TECHNOLOGIST; Geneva General Hospital; Geneva, New York

Departments: Blood Bank; Chemistry; Hematology/Coagulation; Microbiology; Phlebotomy; Serology; Urinalysis

01/1996 - 07/1997: MEDICAL TECHNOLOGIST; Clifton Springs Hospital and Clinic; Clifton Springs, New York

Departments: Blood Bank; Chemistry; Hematology/Coagulation; Microbiology; Phlebotomy; Urinalysis

06/1993 - 01/1996: MEDICAL LABORATORY TECHNICIAN; Clifton Springs Hospital and Clinic; Clifton Springs, New York - Per Diem employee

Departments: Chemistry; Hematology/Coagulation; Phlebotomy; Urinalysis

06/1992 - 08/1992: EXECUTIVE SECRETARY; Fairport, New York

Perform phone reception, dictation, report preparation

01/1991 - 08/1991: SECRETARY; Kelly Services; Fairport, New York

File requests for environmental information

Organize distributions

Apply general office duties

03/1989 - 10/1990: PERSONNEL CLERK; Kelly Services; Fairport, New York

Maintain Hazardous Chemical Communications Program

Update personnel files

Create computerized forms

Complete disability and compensation forms

References available upon request

Contact this candidate