V&V Engineer - Med Tech

Roles & Responsibilities :
We are seeking a detail-orientedEmbedded V&V Engineerwith3+ years of experience in medical device software/firmware testing. The candidate will be responsible forverification and validation of embedded systemsused in medical devices, ensuring compliance with regulatory standards and product quality requirements.

The role involvestest design, execution, automation, defect analysis, and regulatory documentationin a highly regulated environment.

Key Responsibilities

Embedded Software Verification & Validation

• Design and developverification and validation test plans, protocols, and reportsfor embedded systems.

• Performunit, integration, system, and regression testingfor embedded firmware.

• Executemanual and automated testingof embedded medical device software.

Test Development & Automation

• Developautomated test scripts using Python/C/C++ or test frameworks.

• Build and maintaintest benches, hardware setups, and simulation environments.

• Implementcontinuous testing in CI/CD environments.

Compliance & Documentation

• Ensure compliance withmedical device regulatory standardssuch 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

• Preparetraceability matrices, validation reports, and defect documentation.

Collaboration

• Work closely withembedded developers, system engineers, hardware teams, and quality engineers.

• Participate indesign reviews, risk assessments, and root cause analysis.

Defect Management

• Log and track defects using tools likeJIRA, Polarion, or similar ALM tools.

• Performfailure analysis and debugging with developers.

Qualifications

Educational qualification:

B.Tech / B.E

Experience :

• 3+ years of experience in embedded software V&V, preferably inmedical devices.

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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 :

1. Experience working inregulated medical device environments

2. Knowledge ofrisk management and safety-critical software

3. Experience withhardware-in-the-loop (HIL) testing

4. Familiarity withclinical workflow or medical imaging systems