Verification and Validation Lead – Chronic Disease Management

About Us:

How many companies can say they’ve been in business for over 179 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 46,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region: This position is located in Dublin, CA

What’s the role?

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.

Sound Interesting?

Here’s what you’ll do:

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.

Do you qualify?

• 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.

Preferred Qualifications:

• 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 w