Lead System V&V Engineer

We are looking for a Lead System V&V Engineer to oversee product verification efforts within a highly regulated medical device environment. You will ensure that complex systems meet stringent safety and quality standards throughout the entire development lifecycle. This role is based in Pune and operates on a hybrid work model.

Our client is a prominent global software and engineering services provider specializing in complex product development. They support high-stakes industries by delivering innovative technology solutions that prioritize safety, quality, and regulatory excellence. With a strong focus on engineering rigor, they foster a collaborative environment for technical professionals to solve challenging problems.

Responsibilities

• Lead comprehensive system and product verification activities to ensure design integrity.
• Develop and execute robust test design strategies and test method validation protocols.
• Manage system-level documentation to ensure full compliance with the V-Model development framework.
• Collaborate with cross-functional teams to integrate system designs with safety and performance requirements.
• Oversee the verification lifecycle to ensure all regulatory milestones are met.
• Maintain high standards of technical documentation for audit readiness.

Requirements

• 8-12 years of professional experience in system verification and validation.
• Proven expertise in ISO 13485 medical device standards and ISO 14971 risk management processes.
• In-depth knowledge of IEC 60601 standards for medical electrical equipment.
• Bachelor’s or Master’s degree in Biomedical Engineering, Systems Engineering, or a related technical field.
• Extensive experience leading V&V lifecycles within the medical device industry.
• Strong analytical skills with a focus on technical documentation and regulatory compliance.
• Professional certifications in quality assurance or regulatory affairs are highly desirable.