In this role, you will join a team developing medical devices, where software tools play a critical role in product quality, regulatory compliance, and ultimately patient safety.

As a Tool Validation Engineer, you will ensure that development, testing, and quality management tools are validated, fit for their intended use, and compliant with industry regulations. Working closely with engineering, quality, and validation teams, you will help maintain an efficient, risk-based Computer Software Assurance (CSA) approach while ensuring audit readiness throughout the software lifecycle.

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‍As a Tool Validation Engineer, you will drive risk-based validation activities for software tools used across development, testing, manufacturing, and quality processes.

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Other responsibilities would include:

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• Maintain and manage the inventory of software tools used across engineering, testing, manufacturing, and quality management
• Perform risk assessments and classify tools based on their intended use and potential impact on product quality and patient safety
• Plan, execute, and document validation activities following Computer Software Assurance (CSA) principles
• Define validation strategies, acceptance criteria, test environments, and evidence required for tool approval
• Maintain traceability between requirements, validation activities, test evidence, and approvals
• Assess the impact of software updates, patches, and configuration changes, defining appropriate re-validation activities
• Collaborate with engineering teams to ensure validated tools remain compliant throughout their lifecycle
• Monitor validation metrics, audit readiness, and continuous improvement initiatives
• Support internal and external audits by providing clear and well-structure validation documentation

We are looking for a person with the following experience:

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• Experience in software validation, software quality, verification & validation, or a similar role within a regulated industry
• Experience working with regulations and standards such as ISO 13485, ISO14971, IEC 62304, and FDA Computer Software Assurance guidance
• Experience defining validation plans, acceptance criteria, and producing audit-ready validation evidence
• Knowledge of software lifecycle, change management, configuration management, and release processes
• Familiarity with CI/CD pipelines, automated testing environments, or software development tools

• Fluency in English (written and spoken) is required

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