Validation Engineer

Job summary

The role involves preparing, executing, and reporting verification and validation (V&V) for software within a Quality Management System (QMS). The Validation Engineer will also evaluate and qualify suppliers and oversee AI agents.

Qualifications

• Minimum of 3 years of experience in software/system V&V within a regulated environment (medical device, SaMD, digital health, or similar).
• Proficient in ISO 13485 design V&V and/or IEC 62304 standards.
• Experience in protocol authoring, objective evidence collection, and maintaining traceability.
• Familiarity with risk-based assurance and supplier evaluation processes.
• Knowledge of structured-content and evidence-first methodologies is preferred.

Responsibilities

• Develop and implement risk-based V&V strategies tailored to intended-use risks.
• Utilize lower-level test evidence effectively without unnecessary re-execution.
• Maintain automated traceability and ensure continuous control.
• Qualify and manage the toolchain, infrastructure, and internal systems.
• Assess and monitor suppliers, providing recommendations for approval.
• Prepare release evidence packages for regulatory sign-off.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and documentation abilities.

Education

• Relevant degree in engineering, computer science, or a related field is preferred.

Tools

• Familiarity with validation tools and methodologies relevant to software in regulated industries.