Med Device Software Verification & Validation (V&V) Engineer

Job Summary We are seeking an experienced Senior Software Verification & Validation (V&V) Engineer to support software quality activities for regulated medical devices. This role will focus on Software Verification & Validation (V&V), Test Method Validation, software quality, and design assurance throughout the product development lifecycle. The ideal candidate will have extensive experience working in the medical device industry and a strong understanding of FDA regulations and applicable international standards. Key Responsibilities • Plan, develop, review, and execute Software Verification & Validation (V&V) activities for medical device software and embedded systems. • Develop, validate, and maintain test methods, verification protocols, validation plans, and test reports. • Perform Test Method Validation (TMV) to ensure test procedures are accurate, repeatable, and compliant. • Create and execute manual and automated software test cases at the unit, integration, system, and regression levels. • Review software requirements and maintain requirements traceability throughout the development lifecycle. • Support Design Verification and Design Validation activities in compliance with FDA Design Controls. • Investigate software defects, perform root cause analysis, and support CAPA activities. • Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory, and Risk Management teams. • Support Design History File (DHF) documentation and software lifecycle deliverables. • Participate in design reviews, risk assessments, and software quality activities. Required Qualifications • Bachelor's degree in Engineering, Computer Science, Software Engineering, or a related technical discipline. • 8+ years of Software Verification & Validation experience within the medical device industry. • Strong experience with Software Verification & Validation (V&V) and Test Method Validation. • Experience developing and executing software test protocols, validation plans, and verification reports. • Experience with embedded software or Software as a Medical Device (SaMD). Working knowledge of: • IEC 62304 • ISO 13485 • ISO 14971 • FDA 21 CFR Part 820 / Design Controls • Experience with requirements traceability, defect management, and software quality processes. • Excellent written and verbal communication skills. Preferred Qualifications • Experience with Design Assurance or Software Quality Engineering. • Experience with automated testing frameworks and Hardware-in-the-Loop (HIL) testing. • Familiarity with tools such as DOORS, JIRA, HP ALM, TestStand, Jenkins, Windchill, Polarion, or similar. • Experience supporting Class II or Class III medical devices. • Experience with risk analysis, FMEA, CAPA, and Design History File (DHF) documentation.