Verification and Validation Lead – Chronic Disease Management

About This Role

Lead the Verification and Validation (V&V) strategy and execution for medical device products within the Chronic Disease Management division. Ensure compliance with medical device regulations and drive continuous improvement in testing methodologies for advanced ophthalmic imaging and chronic disease management solutions.

Responsibilities

• Develop, own, and execute overall V&V strategy, plans, and protocols for medical device products
• Define and implement testing methodologies for system-level, software, and hardware verification and validation
• Ensure compliance with standards and regulations, including FDA 21 CFR, ISO 13485, ISO 14971, IEC 60601
• Establish traceability matrices linking user needs, design inputs, and test results
• Coordinate and execute design verification testing (bench, systems, software, usability)
• Develop automated testing frameworks and tools to improve efficiency and coverage
• Analyze test results, identify root causes of issues, and drive corrective actions
• Author, review, and maintain comprehensive documentation for V&V activities
• Build, mentor, and lead a high-performing team of V&V engineers and testers
• Drive innovation in testing methodologies, tools, and processes

Requirements

• Bachelor’s or Master’s degree in Electrical Engineering, Physics, Computer Science, or related field
• Minimum 10 years of relevant experience in V&V for medical devices, software, or algorithms
• Strong knowledge of regulatory requirements for medical devices (e.g., FDA, CE, ISO 13485)
• Hands-on experience with testing frameworks and tools (e.g., Selenium, JUnit, pytest)
• Familiarity with ophthalmic imaging modalities and clinical workflows
• Excellent analytical, problem-solving, and communication skills
• Proven ability to lead teams and manage cross-functional collaborations

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Physics, Computer Science, or related field
• Minimum 10 years of relevant experience in V&V for medical devices, software, or algorithms

Nice to Have

• Knowledge with AI/ML algorithm validation and explainability testing
• Knowledge of cloud-based testing environments (AWS, Azure, GCP)
• Familiarity with FDA SaMD and EU MDR regulatory frameworks
• Experience with automated testing pipelines and CI/CD tools

Skills

* Required skills

Benefits