Manufacturing Engineer

Position Summary We are seeking an experienced Manufacturing Transfer Engineer to support manufacturing transfer and product line duplication initiatives across multiple Contract Manufacturing Organizations (CMOs). This role will execute manufacturing transfer activities, coordinate cross-functional teams, and ensure successful product transfers while maintaining quality, regulatory compliance, and uninterrupted product supply. The ideal candidate will have hands-on experience in manufacturing transfers, technology transfer, process validation, and production line duplication within a regulated medical device environment. Key Responsibilities Execute manufacturing transfer activities between external Contract Manufacturing Organizations (CMOs). Develop and maintain transfer plans, project schedules, risk assessments, and execution timelines. Coordinate technology transfer activities, including manufacturing documentation, work instructions, SOPs, and operator training. Support duplication and strategic build-up of manufacturing lines across multiple CMOs to improve supply chain resilience and business continuity. Collaborate with Manufacturing, Quality, Operations, Supply Chain, R&D, Regulatory Affairs, and external manufacturing partners throughout transfer activities. Support equipment installation, qualification, and process validation activities (IQ, OQ, and PQ). Execute Design Transfer activities in accordance with Design Control requirements and applicable Quality System regulations. Prepare and support Engineering Change Orders (ECOs), Change Controls, Deviations, CAPAs, and risk management documentation. Identify manufacturing risks, troubleshoot transfer issues, and implement effective mitigation plans. Support process characterization, process optimization, and continuous improvement initiatives. Monitor project milestones, communicate project status, and escalate risks or issues when necessary. Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP, and internal quality procedures.