Verification and Validation Lead – Chronic Disease Management

Location: Dublin, CA

Remote Type: Onsite

Time Type: Full time

Job Description

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 with automated testing pipelines and CI/CD tools.

The annual pay range for this position is $151,400 – $189,200

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is also eligible for a performance bonus

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Paid time off including vacation, personal, and sick days
• The list goes on!

ZEISS is an Equal Opportunity Employer

Your ZEISS Recruiting Team:

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).