V&V Engineer - Med Tech / Embedded System
Bosch View all jobs
- Coimbatore, Tamil Nadu
- Permanent
- Full-time
We are seeking a detail-oriented Embedded V&V Engineer with 3+ years of experience in medical device software/firmware testing. The candidate will be responsible for verification and validation of embedded systems used in medical devices, ensuring compliance with regulatory standards and product quality requirements.The role involves test design, execution, automation, defect analysis, and regulatory documentation in a highly regulated environment.Key ResponsibilitiesEmbedded Software Verification & ValidationDesign and develop verification and validation test plans, protocols, and reports for embedded systems.Perform unit, integration, system, and regression testing for embedded firmware.Execute manual and automated testing of embedded medical device software.Test Development & AutomationDevelop automated test scripts using Python/C/C++ or test frameworks.Build and maintain test benches, hardware setups, and simulation environments.Implement continuous testing in CI/CD environments.Compliance & DocumentationEnsure compliance with medical device regulatory standards such asU.S. Food and Drug Administration (FDA) guidelinesIEC 62304 Medical Device Software Lifecycle StandardISO 13485 Quality Management System StandardISO 14971 Risk Management StandardPrepare traceability matrices, validation reports, and defect documentation.CollaborationWork closely with embedded developers, system engineers, hardware teams, and quality engineers.Participate in design reviews, risk assessments, and root cause analysis.Defect ManagementLog and track defects using tools like JIRA, Polarion, or similar ALM tools.Perform failure analysis and debugging with developers.QualificationsEducational qualification:B.Tech / B.EExperience :3+ years of experience in embedded software V&V, preferably in medical devices.Mandatory/requires Skills :
Technical SkillsEmbedded systems testingExperience in Med Tech V&V & Know how on ISO 13485, ISO 62304C / C++ understandingPython or scripting for test automationHardware interface testing (UART, SPI, I2C, CAN, USB)Test tools and debugging tools (oscilloscope, logic analyzer)Requirements traceabilityTools & TechnologiesTest management tools (JIRA, TestRail, Polarion)Version control (Git)CI/CD tools (Jenkins, GitLab)Embedded debugging toolsPreferred Skills :Experience working in regulated medical device environmentsKnowledge of risk management and safety-critical softwareExperience with hardware-in-the-loop (HIL) testingFamiliarity with clinical workflow or medical imaging systems