Verification and Validation Lead for Medical Device Software

GE Healthcare Private Limited; Karnataka; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

GE Healthcare Private Limited seeks an experienced Verification and Validation Lead to drive quality, compliance, and product verification for software-intensive medical devices and connected healthcare solutions across the lifecycle.

This role leads end-to-end verification, defines strategies and test plans, ensures traceability, advances automation, and collaborates with cross-functional teams while mentoring engineers and supporting regulatory submissions.

Qualifications

• Proven experience leading verification and validation for complex software products in medical devices.
• Hands-on programming experience in Java, Python, or C#.
• Experience with CI/CD tools and test automation.
• Knowledge of IEC 62304, ISO 13485, ISO 14971, and regulatory submissions is a plus.

Responsibilities

• Lead verification and validation activities for software, systems, and integrated medical device solutions.
• Define verification strategies, test plans, protocols, and quality metrics aligned with product requirements, risk management, and regulatory expectations.
• Ensure complete traceability between requirements, risk controls, verification evidence, defects, and release deliverables.
• Drive risk-based verification approaches in compliance with ISO 14971 and medical device quality processes.
• Develop and maintain automated test frameworks for system, integration, API, regression, and end-to-end testing.
• Enhance test infrastructure, simulation environments, and CI/CD pipelines to improve automation, coverage, and efficiency.
• Lead defect triage, root cause analysis, and resolution planning for product quality issues.
• Collaborate with Software, Systems, Quality, Regulatory, Clinical, and Product teams throughout the development lifecycle.
• Mentor verification engineers and promote best practices in quality engineering, automation, and regulatory compliance.
• Support design reviews, risk assessments, audits, CAPA activities, and regulatory submissions.

Skills

V&V Leadership

Test Automation

Java

Python

C#

CI/CD

Linux/Unix

Windows

Education

Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related STEM discipline

Tools

Java

Python

C#

CI/CD

Linux/Unix

Windows

Docker

Kubernetes

Job description

Verification and Validation Lead Job Description Summary

We are seeking an experienced Verification & Validation Lead to drive quality, compliance, and product verification for software-intensive medical devices and connected healthcare solutions. This role will lead end-to-end verification and validation activities across the product lifecycle, ensuring products meet regulatory, safety, performance, and quality requirements. The ideal candidate combines strong V&V leadership with hands-on expertise in test automation, system verification, and regulated product development. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

tex Job Description

Key Responsibilities

• Lead verification and validation activities for software, systems, and integrated medical device solutions.
• Define verification strategies, test plans, protocols, and quality metrics aligned with product requirements, risk management, and regulatory expectations.
• Ensure complete traceability between requirements, risk controls, verification evidence, defects, and release deliverables.
• Drive risk-based verification approaches in compliance with ISO 14971 and medical device quality processes.
• Develop and maintain automated test frameworks for system, integration, API, regression, and end-to-end testing.
• Enhance test infrastructure, simulation environments, and CI/CD pipelines to improve automation, coverage, and efficiency.
• Lead defect triage, root cause analysis, and resolution planning for product quality issues.
• Contribute to verification of system performance, reliability, scalability, interoperability, and other critical product characteristics.
• Collaborate with Software, Systems, Quality, Regulatory, Clinical, and Product teams throughout the development lifecycle.
• Mentor verification engineers and promote best practices in quality engineering, automation, and regulatory compliance.
• Support design reviews, risk assessments, audits, CAPA activities, and regulatory submissions.

Educational Qualifications

Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related STEM discipline.

Required Qualifications

• Proven experience leading Verification & Validation activities for complex software products, preferably within the medical device industry.
• Strong experience with software test automation and quality engineering practices.
• Hands-on programming experience in Java, Python, C#, or similar languages.
• Experience testing distributed systems, cloud applications, web services, APIs, and device-integrated solutions.
• Experience with CI/CD tools, defect management systems, and requirements management platforms.
• Strong understanding of Linux/Unix and Windows environments.
• Experience with virtualization, containers, simulation environments, and hardware-software integration testing.

Preferred Qualifications

• Experience working within regulated environments governed by IEC 62304, ISO 13485, ISO 14971, FDA Quality System Regulations, and EU MDR.
• Knowledge of Design Controls, DHF, DMR, CAPA, Change Control, and Risk Management processes.
• Experience supporting regulatory audits, inspections, and submissions.
• Familiarity with performance, reliability, and non-functional verification of distributed healthcare systems and connected medical devices.

What You'll Bring

Strong leadership and mentoring capabilities.
Excellent analytical, problem-solving, and decision-making skills.
Passion for quality, patient safety, and engineering excellence.
Ability to influence cross-functional teams and drive a culture of verification, compliance, and continuous improvement.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Experience Level Senior Level

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