Design Assurance Engineer

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 …