Victor Tran
Oakland
Summary
Software quality engineer with expertise in medical devices and robotics software. Successfully led quality activities for new product development, ensuring compliance with regulatory standards and driving FDA submissions. Known for enhancing software risk management practices and implementing process improvements that elevate product reliability.
Overview
11
11
years of professional experience
Work History
Senior Software Quality Engineer
Johnson & Johnson MedTech
Santa Clara
02.2022 - Current
- Lead software quality activities for the Ottava surgical robotic system , ensuring compliance with IEC 62304 and ISO 14971.
- Own the software risk analysis (SWRA) for multiple robotic subsystems, maintaining traceability between requirements, test cases, defects, and risk controls.
- Support successful FDA IDE & De Novo submissions
- Review software requirements, test cases, and defect reports to ensure adequate verification coverage and regulatory alignment.
- Review complaints and field feedback, mapping to risk to assess potential impact and identify risk mitigations.
- Implemented improved defect tracking process in Jira and established trend analysis system for recurring software issues, enhancing visibility and enabling preventive action.
- Support audit activities (front room and back room) and internal quality assessments.
- Conduct SOUP (Software of Unknown Provenance) assessments to ensure third-party components meet quality and cybersecurity requirements.
- Completed AAMI training for ISO 13485
- Tools: Jira (issue tracking), Jama (requirements & test management).
Software Quality Assurance Associate
Wish
San Francisco
07.2021 - 02.2022
- Executed regression and feature testing across marketplace platforms (with 675 million registered users as of 2022) to ensure product reliability during rapid deployment cycles.
- Collaborated with Product, Engineering, and Design teams to verify functionality and proactively identify cross-component issues, enhancing overall product quality.
- Developed and maintained manual test cases in TestRail to ensure alignment with Jira requirements and facilitate comprehensive testing.
- Facilitated QA stand-ups and presented feature demos to stakeholders, increasing transparency into test coverage and readiness for release.
Software Quality Assurance Engineer
Bio-Rad Laboratories
Pleasanton
05.2019 - 07.2021
- Created test plans, test cases, and reports for FDA-cleared (RUO and IVD) desktop and web applications, enhancing quality assurance for Digital PCR instruments.
- Authored and maintained verification and validation protocols, reports, and trace matrices for regulatory submissions, ensuring compliance with industry standards.
- Served as subject-matter expert for integrated software testing, including regression, performance, and firmware integration.
- Partnered with automation engineers to expand test coverage and defined workflows for automation (Cucumber/BDD).
Systems Engineer
Roche Sequencing Solutions (via Bayside Solutions)
Pleasanton
10.2017 - 05.2019
- Supported the development of AVENIO Oncology Analysis software and Tumor Tissue Analysis Kits, enhancing DNA sequencing workflow.
- Owned requirements engineering, risk management, V&V test design and execution, and design control documentation.
- Led FMEA-based risk identification and cross-functional mitigation efforts to ensure usability and patient safety.
- Partnered with software teams to identify and document defects, improving quality via ad hoc and sprint testing.
- Executed system installation qualification and provided software training for Design Validation at customer sites.
Validation Engineer
Biomarin Pharmaceutical (via PSC Biotech)
Novato
10.2015 - 10.2017
- Executed computer system validation (CSV) activities for new processes and system changes, ensuring compliance in a regulated pharmaceutical environment.
- Authored and delivered comprehensive validation documentation, including IQ/OQ/PQ protocols and validation plans, to support regulatory compliance.
- Developed and executed test cases for Oracle ERP and laboratory software, addressing validation discrepancies and deviations to maintain system integrity.
Education
B.S. - Bioengineering
University of California, Los Angeles
Los Angeles, CA06-2015
Skills
- Requirements Engineering
- Verification & Validation strategy development
- Design Controls
- Risk Management
- Software Risk Analysis
- Agile Methodologies
- ISO 14971
- IEC 62304
- ISO 13485
- Audit readiness
- Defect Triage & Management
- Complaint Handling
- SOUP Assessments
- Traceability
- Usability Testing
- Jira
- JAMA
- TestRail
- X-ray
- HP ALM
- Microsoft TFS
Websites
Timeline
Senior Software Quality Engineer
Johnson & Johnson MedTech
02.2022 - Current
Software Quality Assurance Associate
Wish
07.2021 - 02.2022
Software Quality Assurance Engineer
Bio-Rad Laboratories
05.2019 - 07.2021
Systems Engineer
Roche Sequencing Solutions (via Bayside Solutions)
10.2017 - 05.2019
Validation Engineer
Biomarin Pharmaceutical (via PSC Biotech)
10.2015 - 10.2017
B.S. - Bioengineering
University of California, Los Angeles