Manufacturing Engineer

Full-time Engineers

Position Overview: The Manufacturing Validation Engineer will play a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes in compliance with industry regulations and company standards in the medical device sector. This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion. The role requires a blend of engineering, regulatory knowledge, and leadership skills to drive successful project delivery, including documentation, risk management, and effective collaboration across cross-functional teams. Key Responsibilities: Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.). Lead the qualification of new...