Summary
Overview
Work History
Education
Timeline
Generic

BHAWNA CHANDWANI

Senior Software Verification And Validation Engineer
Dun Laoghaire,Dublin

Summary

I’m a quality-focused software professional with over 15 years of experience in testing and automation, especially in regulated medical device environments. I enjoy solving complex problems and collaborating across teams to deliver reliable, compliant softwareDevelopment Life Cycle, and SQA Methodology.

  • Experience of working in regulated Medical Device Companies (Hematology,Radiotherapy products) in Test automation.
  • Good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
  • Extensive knowledge of FDA standards (21 CFR Part 11, 210, 211, 820, 312,50)
  • Experience of writing Software QA documentation (Test plans, Test cases, Test matrices, checklists, Validation plans, bug reports, SOP’s, reviewed User Requirements and
    Specifications, FMEA’s)
  • Extensive background in clinical research and Regulatory Affairs.

Overview

14
14
years of professional experience

Work History

Senior Software QA Engineer

Siemens Healthineers
07.2018 - Current
  • Define test cases, design, and develop tools for functional, stress, performance, security, localization and load testing.
  • Participate in requirement analysis, use case development, and risk hazard analysis.
  • Develop, evaluate, revise, and apply technical quality software assurance protocols and methods to inspect and test in-process raw materials, production equipment, and finished products.
  • Establish and log traceability to requirements and disposition of defects found.
  • Automate clinical workflows, system administration workflows.
  • Analyze, develop, and maintain test scripts for end-to-end treatment delivery workflows.
  • Mentor team members on test automation and tools like ADLM. Support other teams with environment setup and technical guidance.
  • Work with cross functional teams, development engineers, product marketing, and project managers to resolve issues related to usability, requirements, scope, and resources. Provide test estimates and clarify ambiguous acceptance criteria.
  • Develop, implement, and review test plans, test procedures, test reports and traceability matrices that satisfy ISO and FDA requirements.
  • Ensure compliance with company quality assurance standards and applicable government regulations.

Software Test Engineer

Abbott Laboratories
09.2015 - 07.2018
  • Work on several projects and provide work leadership for junior test engineers, Automation teams and offshore teams.
  • Develop, implement, and review test plans, test procedures, test reports and traceability matrices that satisfy ISO and FDA requirements.
  • Write, enhance, review, and execute manual and automated tests for Hematology devices and device Simulators.
  • Responsible for Verification and Validation of testing tools like Analyzer Simulator, Data Extractor, Results Injector, Data Generator.
  • Test HL7, ASTM, and LIS interconnectivity and Data storage scripts.
  • Collaborate with development engineers and scientists to understand requirements and resolve failures.
  • Contribute to estimation of development tasks; participate in daily standups, Release and Sprint Planning, SCRUM meetings.
  • Troubleshoot, debug, and perform root cause analysis of issues found during verification and validation.
  • Report test failures into JIRA and work with engineers to assess risk and corrective action.
  • Lead testing effort of Critical features with strict time constraints.
  • Conduct risk management activities to identify hazards specific to software. Collaborate with various levels of the organization to propose and implement hazard mitigations.

Software QA Engineer

ViewRay, Inc.
04.2014 - 09.2015
  • Participated in product requirements definition, design, and risk assessment. Prepared appropriate technical documentation for Product design history files and FDA submissions.
  • Developed manual and automated test scripts using Test Complete.
  • Served as primary SQA representative associated with MRI simulator, back up and disaster recovery software (Shadow Protect) and backend SQL server testing.
  • Participated in validation of third party DICOM testing tools like Radiant Viewer, Remote testing software’s like GOTOMYPC, Screen Connect.
  • Worked as SQA Lead on several projects of Treatment Planning and delivery software, partnered with development, marketing team to achieve product goals and provided work leadership to team members.
  • Create, develop, and execute validation test cases and prepared associated documentation.
  • Conducted CCB meetings to evaluate and triage software defects.
  • Streamlined the process followed in the Software Test team- designed Test protocol template, developed a work instruction for reporting test results, defined build installation instructions, developed a training plan for new and existing hires.
  • Validated Radiotherapy software post deployment at Customer sites.
  • Setup Software testing lab and processes for software upgrades and smoke testing.

SQA Engineer

Carl Zeiss Meditec
08.2012 - 04.2014
  • Worked on multiple projects CIRRUS HD OCT, HFA, FORUM, HHC, Auto connect, DICOM Gateway, FDT viewer.
  • Executed Perimetry tests, tested import and export of Perimetry data from several generations of HFA systems to a DICOM Compatible data repository.
  • Tested embedded software, client server applications developed in C #.
  • Developed Software Procedures, Plans and Validation Summary Reports that satisfy ISO and FDA requirements, for use in the testing of ophthalmic products.
  • Worked closely with Business users and attend various cross functional team meetings in defining/Clarifying new software requirements and needs.
  • Responsible for maintaining software quality Assurance schedules for specific projects.
  • Documented procedures and test results per ISO requirements.
  • Released Software QA documentation to AGILE and DOORS.
  • Verified Product user manuals, online documentation and helped systems for correctness.
  • Involved in testing of DICOM gateway and HHC tools to move XML data from different source systems (Previous generations of HFA) to DICOM storage server. This included Test Design Development, Setting up different environments for Verification and Release of these products.
  • Facilitated Traceability mappings sessions with Software development and marketing teams.

SQA Engineer

Neuralieve Inc.
02.2012 - 07.2012
  • Tested embedded firmware for device display, treatment pulse log.
  • Tested Secure Web application for patients, physicians, prescriptions, order management, operations, and marketing team.
  • Tested Software to create encrypted SIM cards issued in accordance with prescription to enable only the intended device until prescription expiry, device end of life.
  • Tested Client server applications and Desktop applications Autopilot, Auto sync, Treatment Card Exporter, Treatment Card Writer developed in C++ for manufacturing division.
  • Experience of using FileZilla, Toad, Firebug, HyperTerminal, shell commands, Grand Avenue, Arena, Bugzilla.
  • Participated in Product review meetings, Project Status meetings, Daily stand ups and Milestone meetings.
  • Participated in risk assessment and risk management process.
  • Enjoyed the extra responsibility of being the only QA and learned how to manage projects and document the QA process end to end.
  • Worked with development and requirements definition teams to create, develop, and execute system level (black box) test procedures for V & V testing.
  • Successfully documented and reported test results used for FDA Submissions.

SQA Consultant

Reputation.com
08.2011 - 12.2011
  • Reviewed product documentation with technical writers and provided input to assure accuracy.
  • Contributed to test plans (test approach and time estimation) and developed test cases based on user stories and product requirements.
  • Utilized Trac defect tracking tool, Asana as a project scheduling tool, and Test Link for requirements and test case management.
  • Utilized Salesforce and Marketo, Google Analytics Tool for tracking and generating detailed statistics about the visitors to the website.
  • Installed VMWare virtual machines and created various test environments.

Education

Master of Science - Medical Product Development and Management

San Jose State University
San Jose, CA

Bachelor of Science -

Pt. Ravishankar Shukla University
India

Certificate course - Java and Python

UCSC Extension
California USA

Software Quality Assurance -

Portnov Computer School
California USA

Timeline

Senior Software QA Engineer

Siemens Healthineers
07.2018 - Current

Software Test Engineer

Abbott Laboratories
09.2015 - 07.2018

Software QA Engineer

ViewRay, Inc.
04.2014 - 09.2015

SQA Engineer

Carl Zeiss Meditec
08.2012 - 04.2014

SQA Engineer

Neuralieve Inc.
02.2012 - 07.2012

SQA Consultant

Reputation.com
08.2011 - 12.2011

Master of Science - Medical Product Development and Management

San Jose State University

Bachelor of Science -

Pt. Ravishankar Shukla University

Certificate course - Java and Python

UCSC Extension

Software Quality Assurance -

Portnov Computer School

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BHAWNA CHANDWANISenior Software Verification And Validation Engineer