System Validation Engineer

System Validation Engineers play a critical role in ensuring that medical device systems meet rigorous regulatory standards and quality requirements before reaching the market. This is an opportunity to register your interest in future System Validation Engineer roles within Class III medical device environments, where your work could directly support the delivery of life-changing technology to patients., Roles of this type may sit within a regulated, quality-driven engineering culture focused on Class III medical device validation and compliance. The work could involve partnering across engineering, quality and operations teams to demonstrate that systems meet ISO 13485, IEC 62304 and FDA design control requirements. You could contribute to validating complex medical device systems throughout their development lifecycle, helping to ensure that products reach patients safely and reliably., * Conducting system validation testing to verify that medical device systems meet defined requirements and regulatory standards

• Developing and executing validation protocols, test plans and test cases aligned to ISO 13485 and IEC 62304
• Documenting validation activities, results and traceability matrices for regulatory submissions
• Collaborating with engineering and quality teams to identify and resolve validation findings
• Supporting compliance activities and regulatory reporting
• Contributing to design control and verification activities throughout the product lifecycle, Most roles of this type offer the following, dependent on the industry and seniority of the role:
• Involvement in validating medical device systems that support patient safety and clinical outcomes
• Exposure to best-practice regulatory processes and quality standards within a professional engineering environment
• Contract flexibility and competitive daily rates reflecting specialist expertise
• Opportunity to build expertise in a growing and highly regulated sector
• Potential for contract extension or future permanent opportunities, where supported by business requirements

• Bachelor’s degree in Computer Science or a related engineering discipline
• Experience with system validation, testing or quality assurance in a medical device or regulated manufacturing environment
• Working knowledge of ISO 13485, IEC 62304 and Class III medical device standards
• Familiarity with validation protocols, test case development and traceability documentation
• Strong attention to detail and problem-solving capability
• Authorization to work in the United Kingdom

Nice-to-have:

• Experience with FDA design controls or premarket submission support
• Knowledge of additional quality standards such as ISO 9001 or IEC 61508
• Exposure to software validation or systems engineering methodologies

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