V&V Engineer - Med Tech
Location: coimbatore, in
Company Description
Bosch Global Software Technologies Private Limited is a 100% owned subsidiary of Robert Bosch GmbH, one of the world's leading global supplier of technology and services, offering end-to-end Engineering, IT and Business Solutions. With over 27,000+ associates, it’s the largest software development center of Bosch, outside Germany, indicating that it is the Technology Powerhouse of Bosch in India with a global footprint and presence in the US, Europe and the Asia Pacific region.
Job Description
Roles & Responsibilities :
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 Responsibilities
Embedded Software Verification & Validation
Design 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 & Automation
Develop 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 & Documentation
Ensure compliance with medical device regulatory standards such as
U.S. Food and Drug Administration (FDA) guidelines
IEC 62304 Medical Device Software Lifecycle Standard
ISO 13485 Quality Management System Standard
ISO 14971 Risk Management Standard
Prepare traceability matrices, validation reports, and defect documentation.
Collaboration
Work closely with embedded developers, system engineers, hardware teams, and quality engineers.
Participate in design reviews, risk assessments, and root cause analysis.
Defect Management
Log and track defects using tools like JIRA, Polarion, or similar ALM tools.
Perform failure analysis and debugging with developers.
Qualifications
Educational qualification:
B.Tech / B.E
Experience :
3+ years of experience in embedded software V&V, preferably in medical devices.
Mandatory/requires Skills :
Technical Skills
Embedded systems testing
Experience in Med Tech V&V & Know how on ISO 13485, ISO 62304
C / C++ understanding
Python or scripting for test automation
Hardware interface testing (UART, SPI, I2C, CAN, USB)
Test tools and debugging tools (oscilloscope, logic analyzer)
Requirements traceability
Tools & Technologies
Test management tools (JIRA, TestRail, Polarion)
Version control (Git)
CI/CD tools (Jenkins, GitLab)
Embedded debugging tools
Preferred Skills :
Experience working in regulated medical device environments
Knowledge of risk management and safety-critical software
Experience with hardware-in-the-loop (HIL) testing
Familiarity with clinical workflow or medical imaging systems
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