System Validation Engineer

This opportunity invites professionals to register their interest in future System Validation Engineer roles focused on Class III medical device validation and compliance. These positions centre on ensuring that sophisticated medical devices meet rigorous regulatory standards through comprehensive testing and validation protocols across development and manufacturing lifecycles., This is an opportunity to register your interest in future System Validation Engineer positions within Class III medical device development and manufacturing environments. Roles of this type would support the delivery of life-changing technology by ensuring that devices meet stringent regulatory requirements under ISO 13485 and IEC 62304, with potential involvement across design verification, design validation and ongoing quality assurance activities., * Developing and executing test protocols and validation plans aligned with IEC 62304 and ISO 13485 requirements

• Conducting functional, performance and safety testing across hardware, software and integrated systems
• Documenting test results, traceability matrices and validation reports for regulatory submission
• Supporting design verification and design validation activities throughout the product development lifecycle
• Collaborating with engineering, quality and regulatory teams to ensure compliance with Class III medical device standards
• Contributing to continuous improvement of validation processes and procedures
• Identifying and reporting deviations, non-conformances and potential risks during testing and validation activities, Most roles of this type offer the following, dependent on the industry and seniority of the role:
• Engagement in mission-critical validation work that directly supports patient safety and regulatory compliance
• Exposure to sophisticated Class III medical device technologies and regulated development environments
• Potential to develop deep expertise in medical device validation standards and best practices
• Collaboration with experienced engineering and quality teams
• Clear technical progression and skill development in a specialized, high-impact domain
• The flexibility and variety that contract-based engagement can provide

• Bachelor’s degree in Computer Science, Engineering or a related technical discipline
• Working knowledge of ISO 13485 (Medical Device Quality Management) and IEC 62304 (Medical Device Software Lifecycle)
• Experience with Class III medical device validation, testing or quality assurance
• Proficiency in test planning, test execution and technical documentation
• Familiarity with design controls, traceability and regulatory compliance frameworks
• Strong analytical and problem-solving capabilities
• Authorization to work in the United Kingdom

Nice-to-have qualifications could include:

• Additional certifications in quality management or medical device compliance
• Experience with specific validation tools or test automation platforms
• Exposure to FDA or international regulatory submission processes
• Understanding of risk management frameworks such as ISO 14971

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