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 complia...