Verification and Validation Lead – Chronic Disease Management

ZEISS Group•Dublin, CA

7d•$151,400 - $189,200

About The Position

We are seeking a technically skilled and detail-oriented leader to serve as the Verification and Validation (V&V) Lead for our Chronic Disease Management division. This role will oversee the development and execution of V&V strategies and testing tools for advanced algorithms, software, hardware and systems in ophthalmic imaging and chronic disease management. You will ensure compliance with regulatory requirements, maintain high-quality standards, and drive continuous improvement in testing methodologies. This position reports directly to the Head of R&D Workflow Glaucoma & Comprehensive Care and plays a critical role in ensuring the reliability, safety, and performance of ZEISS’s AI-driven solutions. You will collaborate closely with cross-functional teams, including software engineering, clinical affairs, regulatory, and product management, to deliver innovative and compliant solutions to the market.

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.

Nice To Haves

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.

Responsibilities

Verification & Validation Strategy Develop, own, and execute the 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 but not limited to: FDA 21 CFR, ISO 13485, ISO 14971, IEC 60601.
Establish traceability matrices to link user needs, design inputs, and test results.
Testing & Quality Assurance Coordinate and execute design verification testing (bench, systems, software, and usability).
Develop automated testing frameworks and tools to improve efficiency and coverage.
Analyze test results, identify root causes of issues, and drive corrective actions.
Support risk management activities by ensuring test coverage aligns with risk controls.
Documentation & Regulatory Compliance Author, review, and maintain comprehensive documentation for V&V activities, including plans, protocols, and reports.
Ensure traceability from user needs and design inputs through verification and validation.
Support regulatory submissions by providing evidence of compliance and validation results.
Leadership & Collaboration Build, mentor, and lead a high-performing team of V&V engineers and testers.
Collaborate with cross-functional teams including systems engineering, quality, regulatory, manufacturing, service, and product management.
Partner with external stakeholders, including academic institutions and clinical partners, to validate novel approaches.
Continuous Improvement Drive innovation in testing methodologies, tools, and processes to enhance efficiency and effectiveness.
Stay updated on emerging trends in V&V for AI, medical imaging, and regulated environments.