V&V Engineer Med Tech

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.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 :

1. Experience working in regulated medical device environments

2. Knowledge of risk management and safety-critical software

3. Experience with hardware-in-the-loop (HIL) testing

4. Familiarity with clinical workflow or medical imaging systems

Remote Work :

No

Employment Type :

Full-time