Jobs in Farnham, surrey, uk

This is a fantastic opportunity for an experienced Design Assurance Engineer who will oversee design assurance activities, compile technical documentation, conduct test analysis, and ensure design control compliance. This role involves close collaboration with quality, regulatory, and engineering teams to support successful product development and transition into manufacturing.Key Responsibilities : Manage design assurance activities to ensure compliance with regulatory and quality standards.Oversee design control documentation, technical files, and risk management processes.Support design verification and validation activities, including test planning and analysis.Collaborate with R&D, projects, and quality teams to ensure successful product registration and compliance with ISO 13485 and other relevant standards.Participate in internal and external audits, addressing corrective actions as needed.Lead and support Risk Management activities (ISO 14971) for new and modified products, including risk assessment, authoring risk management plans and reports, and facilitating risk assessment activities.Lead and support design or engineering changes to products, supporting product lifecycle and changes for customer products.Performance Objectives : Ensure traceability of design control activities and compliance with safety and performance requirements for product release.Launch products on time in compliance with relevant local and global regulations.Maintain regulatory compliance to meet company objectives.Essential Attributes : Hands-on experience with design control, risk management, and product development processes.Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, UKCA, and other medical device regulatory requirements.Qualifications / Experience : Degree in engineering, science, or a related technical field.Minimum of 3 years of experience in a Design Assurance, Quality Assurance, or Regulatory role within the medical device industry.Desirable : Experience in wound care and sterile system design and testing.

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