Pooja Hariharan
Automotive Engineer | ISO26262 certified | ISTQB certified | ADAS Features Testing | HIL/SIL Testing | CAN/UDS| DSpace/CANoe |
- Role
- Software Verification and Validation Engineer 3 at Hologic, Inc.
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Pooja Hariharan
Verification & Validation (V&V) Engineer with 10 years of experience across medical devices and automotive systems · Strong experience in system-level validation, test strategy, and test method development · Understanding of regulatory and quality standards including FDA guidelines, ISO 13485, and ISO 26262 · Experience working across Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) · Proficient in requirements analysis, test case design, execution, and defect management · Skilled in requirements traceability and ensuring end-to-end test coverage · Hands-on experience with Hardware-in-the-Loop (HIL) testing and validation environments · Hands on Experience in HIL (Hardware-in-the-Loop) testing using dSpace (Automation Desk, Control Desk, Model Desk, Motion Desk).Experienced in using tools like Vector CANoe, Danview, Drivescope, Jenkins, Tessy · Has experience in different vehicle communication and diagnostic protocols like CAN and UDS.
Experience
Software Verification and Validation Engineer 3
Feb 2023 — Present · US
Performed verification & validation of critical new features for Class II medical devices, ensuring compliance with FDA and ISO 13485 standards • Developed UI Software Design Specifications (SDS), ensuring end-to-end traceability between requirements, design, and validation artifacts • Ensured comprehensive test coverage by mapping requirements to test cases using ALM for requirement and test case traceability.• Managed defect tracking and reporting using JIRA and PTC Windchill, ensuring timely resolution and communication with cross-functional teams • Conducted peer reviews of test artifacts and validation documentation • Performed internal audits prior to release milestones, ensuring complete test coverage and validation readiness • Troubleshot field-reported issues and supported Root Cause Analysis (RCA)• Collaborated with R&D, QA, and Regulatory teams to support validation activities and product releases
Education
K S School of engineering and management
Bachelor of Engineering - BE, Electrical, Electronics and Communications Engineering
2010 — 2014
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