Verification and Validation Engineer

Job Description

We are seeking an experienced Software V&V Engineer to join a cross-functional team supporting software verification and validation activities for complex medical device and electro-mechanical systems. This role offers the opportunity to work closely with Software Engineering, Quality, and Test teams while contributing to product quality, regulatory compliance, and successful product development.

Key Responsibilities

• Develop, review, and execute software verification and validation test cases, protocols, and reports.
• Perform functional, integration, system, and regression testing of software applications and systems.
• Analyze software requirements and specifications to ensure complete test coverage and traceability.
• Document test results, investigate defects, and collaborate with development teams to resolve issues.
• Support risk management activities and verification of risk control measures.
• Ensure compliance with applicable regulatory and quality standards, including IEC 62304, ISO 14971, and FDA requirements.
• Maintain requirement-to-test traceability using tools such as JIRA, Polarion, Jama, or similar platforms.
• Assist with qualification and assessment of testing tools, equipment, and processes following business acquisitions and integrations.
• Contribute to continuous improvement of software testing methodologies and quality processes.

Required Qualifications

• Bachelor's or Master's degree in Engineering, Computer Science, Software Engineering, or a related technical field.
• 5+ years of experience in Software Verification & Validation (V&V), Software Testing, or Quality Engineering.
• Experience working with complex electro-mechanical systems and/or medical devices.
• Strong understanding of software development lifecycle (SDLC), software testing methodologies, and defect management.
• Experience with regulatory standards such as IEC 62304, ISO 14971, and FDA guidelines.
• Proficiency with test management and requirements traceability tools such as JIRA, Polarion, or Jama.
• Strong analytical, troubleshooting, and documentation skills.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD).
• Knowledge of automated testing and scripting languages such as Python or similar.
• Experience supporting regulatory audits, submissions, or compliance activities.
• Familiarity with risk-based testing approaches and design controls.