BERNADETTE O’KEEFE

** ***** ***** • Danbury, CT • 06810

• CELL PHONE 203-***-****

• E-MAIL: ad2lut@r.postjobfree.com

A Senior Software Verification and Validation Engineer and Team Leader in the Healthcare industry proficient in Medical Devices and Software Engineering Practices. Proven proficiency in executing software validation use cases and verification procedures, to guarantee product readiness for market launch. Knowledge of FDA and CE regulations and standards as applied to medical instrumentation and software applications.

Work experience

2006 – Present Senior Software Engineer and Team Leader, Hologic, Danbury

Responsible for the development and execution of the verification and validation test procedures over a wide range of Mammography and Biopsy systems for many key releases of software.

Team Leader for many products software releases, responsibilities included.

oWriting the test Verification and Validation plan.

oReviewing the Design Requirements Documents and the Software Requirements providing input and feedback.

Using both Jama and DOORs Requirement Management Software.

oReviewing the Customer Requirements Documents and the User Needs for System Validation testing

oMentoring and leading other team members in writing and executing Verification Procedures

oWriting Verification and Validation test reports

oDeveloping and completing the Verification and Validation Traceability Matrix’s

oReviewing and Contributing to the Software Risk Management Documents

oCreating and submitting all Design Documents and Reports to the Agile Product Lifecycle Management

oDeveloping and execution of use case test procedures for all Mammography and Biopsy products.

oWorks closely with the Clinical Applications group to capture and document their testing in a use case procedure.

Review and installation of the software following the Field Modification Instructions (FMI) over all products.

Review and provide feedback to the Technical Publishing group for all the User and QC manuals.

Leading the Verification and Validation for the experimental Contrast Enhanced Digital Mammography equipment placed at several clinical sites around the world to gather clinical data and drive product definition.

oResponsible for maintaining all the software configurations for the experimental Contrast Enhanced Digital Mammography equipment.

Provide support to Applications, Service and Manufacturing on any queries or help needed with the many software releases over the entire product line.

Entering software issues, enhancements or specification changes found during testing into the defect tracking system.

oKnowledgeable in Dev Track, Clear Quest and Jira tracking systems.

Leader of the Development Change Control Board and the System Change Control Board running weekly and biweekly meetings to review and disposition all reported software and hardware defects.

Identifying what software procedures can be automated and overseeing the automation process.

Team Leader in the preparation of key new products in the software for early submission to the FDA, the goal being that these new products will have FDA approval by the time the software is ready to be released. Works with the AI group to make this happen.

Provide input and own Continuous Improvement Processes.

1995 - 2006 Software Verification Team Leader, Bayer Diagnostics

Tarrytown, NY

Managed the software verification for over 20 releases of software for numerous Clinical Chemistry OEM Analyzers to achieve IVDD compliance. IVDD compliance is a requirement necessary for sales access to the European markets.

Developed the Master Software Verification Test Plan for the IVDD software release.

Responsible for writing test cases and regression test procedures for compliance to User Specifications Documents.

A team leader responsible for managing a team of technicians to perform medical system testing in accordance with specific validation test procedures.

Managed the test case execution and the regression testing for each release of software.

Responsible for tracking, reviewing, and prioritizing all software incidents reported against the software.

Responsible for writing and issuing the Final Software Verification Report.

Participated in the review of the Service Software Installation Bulletin and informed the service group of any special software instructions or workarounds.

Participated in the subject expert review for the online Operator Help.

Responsible for the validation of the Hard Disk Restore Tool. This is a Service Tool used during installations at customer sites.

Responsible for the investigation and resolution of software related problems reported from Customer Sites (Gem Complaints).

Participated in the review of Multi Site Work Instructions issued for Software Verification.

Responsible for the forecasting and ordering of all the reagents needed to perform the software testing on the instruments.

Instrument experience includes Hematology, Immunology and Biochemistry.

Knowledgeable in FDA Guidance for General Principles of Software Validation.

1987 – 1995 Test Technician, Bayer Diagnostics, Dublin, Ireland

Worked as a Final Test Technician for multiple instruments including Hematology, Chemistry and Immunology Analyzers.

Responsible for instrument Final Testing for system validation, prior to final customer shipment. This included the execution of systems carryover and precision studies to verify the readiness of the system.

Responsible for recording and trouble shooting of problems found during the final system validation and implementing a resultant solution.

A technical team member responsible for the transfer of a Hematology Product from Research and Design in Tarrytown New York to Manufacturing in Dublin Ireland.

Provide laboratory support for sample and reagent preparation for use during final test of the analyzers.

EDUCATION

BS Chemistry GMIT Galway, Ireland.

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