InSitu Technologies Inc. | Internship
Feb 2025 – Present | United States | On-site
- Designed and executed manual and automated test cases under IEC 62304, mapping each case to software requirements and risk controls to maintain full requirements-to-test traceability.
- Wrote and ran automated regression checks using Python and Selenium across a suite of approximately 102 test cases alongside manual test execution to verify software functionality.
- Executed performance and functionality test protocols for a Class III intravascular device as part of a 5-year real-time aging study, documenting results in the eQMS.
- Maintained traceability between requirements, test results, and logged defects in the eQMS and bug tracking system to support release readiness review.
- Investigated a customer complaint using PFMEA, performed root cause analysis, and documented findings in the product monitoring form to support post-market surveillance reporting.
- Closed CAPAs for software documentation gaps by diagnosing issues and coordinating fixes with engineering and quality teams.
- IQ/OQ/PQ protocols for new cleanroom equipment and sterilizer validation, scripting test steps and tracking deviations through closure; supported packaging validation covering seal strength, bubble, and dye tests.
- Assisted in Scrum planning for the SaMD design phase, supporting definition of intended use, hazard identification, and drafting of the risk management plan under ISO 14971.
- Supported computer system validation (CSV) across the software lifecycle using the V-model, performing SOUP validation and ensuring compliance with IEC 62304, ISO 82304, and FDA cybersecurity guidance.
Skills: AI Engineering, API Integration, Medical Device Quality Systems, Process Validation, Automation, C#, SQL, Minitab, eQMS, Regulatory Compliance, TestRail, Polarion ALM, Jira, HIPPA compliance, HL7
Data Logics | Internship
Aug 2024 – Dec 2024 | United States
- Designed and optimized data pipelines in Azure Databricks and Azure Data Lake, implementing ELT processes across bronze, silver, and gold layers.
- Managed efficient schema design with DDL scripts and shared solutions through GitHub for collaboration and version control.
- Processed large datasets, maintained historical records, and enforced business rules in enterprise data warehouses.
- Collaborated with teams to transform raw data into actionable insights, supporting reporting and analytics initiatives.
- Worked with subject-oriented architectures and dimensional data modeling techniques.
Skills: Data Modeling, Python, Azure Databricks, Azure Data Lake, SQL, ETL/ELT, Data Warehousing, Git, Analytics
- ERP https://github.com/insitutech/ERP
- Limen (Class B medical software for stent sizing and guide catheter recommendation)
- Agent Triage for complaint handling
