Total 1 process development engineer job vacancies in Engineering category in coimbatore

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.