SUMMARY:

• Many years of industry experience in quality assurance and software test of, Medical Devices, and complex instrumentation. Performing Verification and Validation Testing of products supported by external workstations, networked, SQL database, embedded firmware in a Government regulated environment.
• Wrote, edited & maintained: Master Requirements documents, Test Plans, Test cases and Final Reports, Technical Manuals for Manufacturing Process Sop’s, Assembly, and Test & Troubleshooting. Working knowledge of Laboratory, Manufacturing, GMP\QSR, and ISO environments, standards ISO 13485, FDA 21 CFR part 11 and 21 CFR 820.
• Identified risks and hazards of the software under test in its safe design and maintenance under IEC 62304
• Performed Software and Hardware manual, functional quality and reliability tests, tracking status progress and escalation as appropriate throughout development life cycle.
• Work with QA Analysts and Developers to ensure that all aspects of the system have proper testing coverage and overall system reliability, performance and quality in a FDA regulated environment.
• Comply with the system development life cycle (SDLC) by participating in scope assessment, risk and cost analysis. Provides leadership and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members.
• Deliver effective and efficient testing management by meeting key project milestones and overall project deliverables on time, and adhering to development and quality standards.
• Analyze the testing needs and develop testing strategy and plans. Review and approve test plans, scenarios, scripts or procedures such as database impacts, software scenarios or usability.
• Review software documentation to ensure technical accuracy, compliance or completeness and/or to mitigate risks.
• Responsible for engaging strong interdepartmental and cross - functional/organizational relationships to drive compliance to Quality System.

PROFESSIONAL EXPERIENCE:

Sr. Software Test engineer

Confidential, North Haven, CT

Responsibilities:

• System Software test of a robotic surgical scalpel in research and development, agile methodology.
• Creation of compliance documents: test cases, unit tests, trace matrix, architecture. Patient invasive FDA regulated device.

Sr. Test Engineer

Confidential, Highland Heights, OH

Responsibilities:

• System test of a CT/ PET positron emission tomography Philips medical imaging Instrument.
• System level verification test case execution. Analyzing test results, the cause of errors, and giving feedback to the development engineers through verbal and defect management tools. (FDA regulated device)

Sr. Software Test engineer

Confidential, Indianola, PA

Responsibilities:

• Verification and Validation/ Software Test of a patient radiology solution for FDA regulated medical imaging powered injectors for contrast using programmable protocols.
• Create and update test plans and test protocol scenarios and requirements in compliance to FDA and ISO regulations .
• Document and analyze test results and recommend work product improvements

Lead Systems Validation and Verification Engineer

Confidential, Dallas TX

Responsibilities:

• Duties include, planning and development of Lifecycle documentation for Test protocols (IQ/OQ/PQ), Requirements, Functional Specifications, Test Plans, Traceability.
• Additional duties include, test setup and execution, defect tracking, writing test reports, White Box, Black Box and debug testing as well as closely with the company software development team to ensure correct software and hardware functionality.
• Understanding of regulatory verification (non-software verification), Validation CAPA and completed internal audit training for business and compliance purpose.

Environment: HP-QualityCenter, DOOR s -IBM, JIRA, KANBAN, BAMBOO, Agile Scrum, XML, HTML, Confidential, MS- office.

Lead Validation Test Engineer

Confidential, Santa Clara, CA

Responsibilities:

• Lead of four member quality team, System level testing of embedded and application software, hardware electromechanical devices and the Verification and Validation testing of Gene Chip instruments, used to analyze complex genetic information for different industries: pharmaceutical, biotechnology, agrochemicals, academic, government to analyze the relationship between genes and human health IVD detection of Cancer and hereditary disease.
• Integration testing to verify functional, performance and reliability requirements placed on major design items; including test method validation of a FDA regulated class II device.Plan, design, develop and execute test cases for Instrument Control software, acceptance testing, ad-hoc testing, alpha testing, beta testing, black box testing, comparison testing, compatibility testing, end-to-end testing, exploratory testing, regression testing and functional testing. Embedded software testing using proprietary test tools. Log defects and validate bugs.
• Identify System level failure modes (FMEA), assess risk, triage. Five years’ experience investigating complaints and trend failures for corrective action preventative action (CAPA), designed experiments.
• Test the application for reliability, safety, user error messages, and user friendliness.
• Develop new test procedures and modify existing procedures per current functionality.
• Project Lead in System Quality Assurance and continue support until product release.
• Work in conjunction with Software Developers in an Agile Programming, C# environment.
• Recommend changes to instrumentation workflow and functionality.
• Work in all aspects of the software development life cycle SDLC.
• Wrote detailed test protocols that adhered to hardware and software design requirements.
• Wrote test results reports, wrote system test plans, test cases, traceability matrix. Wrote and edited customer manual, user manual, customer and service SOP documents, installation & quick start documents in a highly regulated environment complying with ISO 13485.
• Produced standard operating procedures for the quality assurance of calibration, measurement, operation, installation, and the troubleshooting of hardware electromechanical systems and sub-systems to close tolerances.

Software Quality Assurance Engineer

Confidential, CA

Responsibilities:

• Functional, Regression and System software testing of applications for complex devices in a C#, PHP environment.
• Testing of software on Medical Device patient monitoring and analytical chemistry A1c chromatography instrumentation IVD (FDA regulated medical devices).

Senior Software Test Engineer

Confidential, San Diego, CA

Responsibilities:

• Contracted to Thermo Electron Fisher Scientific Instrumentation division
• Wrote test plan and test cases the performed verification Software testing of laboratory instrumentation application program; SQL scripting of database, C & Java environment, and user access security & user time stamping for 21 CFR part 11 compliance using QuickTest pro for GUI testing (FDA regulated medical device).

Manager Field Service

Confidential, San Diego, CA

Responsibilities:

• Hands on Supervision, training & development of 12 field service network engineers in seven geographically remote laboratory facilities. Increased productivity nearly 100% while maintaining high quality levels.
• Developed and implemented test plans, requirements and standard operating procedures SOP’s, reported status for the validation, operational, installation quality and of complex hardware communications instrumentation.

Senior Software QA Engineer

Confidential, Cupertino, CA

Responsibilities:

• Performed comprehensive Software Testing & support on a multi-tiered system Sun Solaris UNIX and Win OS platform, Java, Javascript, Visual Basic . Software was a Web based: time, accounting billing, & merchant credit card application used in the telecommunications VOIP, On line Gaming, SQL scripting, with an Confidential database.
• Improved department’s productivity by balancing workload between four remote geographical offices.

Supervisor System Test

Confidential, Foster City, CA

Responsibilities:

• Managed, planned, and organized activities of a team of System Quality Test technicians in the manufacturing test production facility and National & International Field Service Engineers. (FDA regulated device)
• Performed QA Testing for firmware and applications software and setup, test SOP’s & writing final reports for Installation Qualification (IQ), and Operational Qualification (OQ) for a patient chemistries IVD Medical Device.
• Created a quality and reliability improvement of 50% greater since assuming department responsibilities.

Sr. Systems Test Lead

Confidential, Roche, CA

Responsibilities:

• Directed the activities of fourteen system test technicians in the manufacture and quality assurance of complex electro-mechanical Clinical Chemistry, Immunoassay, Drugs of Abuse Laboratory analyzer IVD Medical Device.
• Performed functional software, device validation and verification testing and Installation Qualification (IQ), and Operational Qualification (OQ). Reduced instrument qualification time by 50% . (FDA regualted device)