Software V and V - Consultant
(2026-03)
- Conducted end-to-end testing of enterprise software tools including Rootly, GitHub, Adobe Sign, and Datadog to validate functionality, reliability, and compliance within a regulated medical device environment.
- Developed and executed comprehensive test plans and test cases for incident management workflows in Rootly, verifying escalation paths, alert routing, and on-call scheduling configurations.
- Performed end-to-end testing of GitHub repository workflows, including pull request processes, branch protection rules, code review pipelines, and CI/CD integrations to ensure traceability and audit-readiness.
- Validated Adobe Sign electronic signature workflows for compliance with 21 CFR Part 11 and applicable regulatory requirements, including testing signature authentication, audit trails, and document routing.
- Executed functional and performance testing in Datadog, verifying dashboard configurations, alert thresholds, log monitoring pipelines, and integration with upstream data sources.
- Documented test results, defects, and deviations in accordance with medical device quality management system (QMS) standards, ensuring full traceability from requirements through test execution.
- Collaborated with cross-functional teams including software engineering, IT, and regulatory affairs to validate tool configurations met business and compliance requirements.
- Identified, logged, and tracked software defects through resolution, retesting fixes to confirm issues were resolved prior to production deployment.
- Supported User Acceptance Testing (UAT) activities and obtained sign-off from stakeholders across quality, operations, and engineering teams.
Manager, Quality Engineering, Digital and Data Software products - Intuitive Surgical
(2020-12 - 2026-03)
- Managed digital and data software product quality for both new product development and sustaining products, focusing on emerging technologies in digital health, health software, software as medical device, and MDDS.
- Implemented CSA policies and procedures to support non-product GxP Computer Systems Validation resulting in cost savings of 20+M for the Digital organization.
- Established meaningful metrics to measure quality and operational excellence within the team and implemented a consistent process for assessment and continuous improvements.
- Built and led a high-performing software QE team of 10 from scratch, which involved hiring, coaching, and mentoring team members.
- Oversaw the delegation and assignment of work within the team, actively participating in resource planning for current and future projects.
- Effectively communicated resource needs to leadership and management, providing recommendations to address resource and skill gaps.
- Demonstrated effective people management and leadership skills, leading, and supporting direct reports' development and growth opportunities with regular feedback.
- Collaborated with cross-functional teams and leadership to champion product quality and integrate quality considerations into key decisions.
- Mentored and coached teams in the creation of design and development plans, integration, verification and validation plans, software requirements specifications, design documents, design reviews, Risk Management File (RMF), test strategy, reports, and traceability matrices.
Software QA Engineer - Verily life science (Google health)
(2020-06 - 2020-12)
- Launched multiple products related to digital health, health IT, mobile medical applications and Medical devices.
- Participated in ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tools initiatives, through the integration of medical device industry best practices.
- Supported software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
- Guided software development teams in design controls and risk management activities.
- Demonstrated ability to implement and improve Software QMS processes using SDLC best practices.
Sr. Software QA Engineer - Talis Biomedical
(2020-01 - 2020-06)
- Reviewed software requirements for a IVD diagnostic Class II medical device to ensure alignment with Quality and regulatory standard
- Performed software validation on software tools and configurable software applications.
- Implemented the Quality management process of software bug/issue tracking to ensure appropriate logging, assessment, resolution, and closure of identified bugs.
- Worked closely with the Software Engineering team in creating documentation and standard operating procedures (SOP) related to Software Development Life Cycle (SDLC).
- Ensured incorporation of all software quality activities as defined in IEC 62304 regarding the software development life cycle.
Sr. Software V and V Engineer - Inovio Pharmaceuticals
(2016-01 - 2019-08)
- Led Quality efforts for embedded software on medical device that resulted in FDA approval to begin phase III clinical trials.
- Owned and managed End to End CSV activities in compliance with GAMP5, GxP, 21 CFR Part 11 regulations on an automated computer system used in manufacturing process resulting in increased throughput and successfully configuring and shipping devices out to clinical sites
- Managed Computer system validation of a clinical database management system performed by Third Party Supplier ensuring they adhere to our Quality standards and GCP regulation resulting in improved clinical trial data management
- Managed testing of product and non-product related software, web application, PC and COTS tools adhering to Quality Management standards.
- Managed the creation and maintenance of test plans, test protocols, test cases, test data and test reports on various test management tools such as Quality Center, Polarion and JIRA.
- Guided development teams in design controls, risk management activities and coordinated on defect triage & tracking and traceability.
- Enhanced test quality and effectiveness by enforcing good quality practices while understanding the nuances of getting a release out on time resulting in significant reduction in software defects.
- Authored several documents including IQ, OQ, PQ protocols and reports, SOP, work instructions, risk management file, overall summary report, anomaly reports, in support for regulatory submissions.
Sr. Software V and V Engineer - Hologic
(2015-05 - 2016-01)
- Lead software test efforts for an embedded fully automated IVD diagnostic Class II medical device.
- Developed test plans based on requirements specs and performed requirements mapping.
- Executed test suites in an FDA/UL regulated environment and reported software & firmware defects.
- Assisted with all aspects of the medical device life cycle process, IEC 62304.
- Worked with development and system engineers on improvements and troubleshooting field complaints.
- Reviewed documentation and test scripts generated by other software test engineers.
- Performed role of a training coordinator, designed exercises, scripts and documentation for new users.
- Developed manuals, V&V plans and acceptance criteria documents. Ensured software validation procedures are maintained and kept current with FDA guidelines
Sr. Test Associate - Prometheus Labs
(2011-06 - 2015-05)
- Responsible for manual QA testing of clinical sample analysis device.
- Created and executed test plans, logged defects in JIRA and coordinating with developers on fixes.
- Responsible for training associates, updating management, writing defect summaries, test reports, clinical forms, laboratory manuals and maintaining QC documents.
- Performed maintenance and calibration of various automation equipment.
Sr. Research Associate, Applications Development / Testing - Cyntellect Inc - San Diego, CA
(2007-10 - 2011-06)
- Developed test applications for the in-house cell culture device named 'LEAP' (Laser Enabled Analysis and Processing). Performed system and acceptance testing during user testing phase, validating (IQ, OQ, PQ) the functionality of the system under test for commercial devices.
- Played an active role writing software test requirement from the application specification.
- Conducted product and complaint investigations with follow-up as required for associated CAPAs.
- Reviewed, triaged and managed field complaints to ensure appropriate action and closure.
Research Assistant, Stem cell Center - Burnham Institute of Medical Research - San Diego, CA
(2006-10 - 2007-10)
- Performed stem cell culturing, designed experiments for stem cell characterization.
- Faculty at the CHOC Human Embryonic stem cell training course offered to pharmaceutical companies and academic laboratories.
- Established protocols and guidelines for training students on "human embryonic stem cells comprehensive training course 2007" at the Burnham Institute.
Research Associate II, Regenerative cell technology group - Cytori Therapeutics Inc - San Diego, CA
(2005-08 - 2006-08)
- Developed and validated a system that performs stem cell isolation from human tissue.
- Responsible for preclinical tests, data analysis, assay runs and laboratory documentation.
Intern, Research and Development Group - Medtronic Minimed - Northridge, CA
(2005-05 - 2005-08)
- Responsible for developing test plans to test a glucose monitoring device "Guardian RT"
- Worked on performance optimization of Glucose monitoring in accordance with GMP standards.
