Manufacturing Engineer

Travel to Costa Rica as needed – Expense Paid

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.

• 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 elevate risks or issues when necessary.
• Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP, and internal quality procedures.

• Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a related engineering discipline.
• 5+ years of experience in Manufacturing Engineering, Process Engineering, Manufacturing Transfer, Technology Transfer, or New Product Introduction (NPI) within the medical device industry.
• Experience supporting manufacturing transfers between internal manufacturing sites and/or external CMOs.
• Experience with manufacturing line duplication, production scale‑up, or manufacturing expansion projects.
• Hands‑on experience supporting equipment qualification and process validation (IQ/OQ/PQ).
• Working knowledge of Design Transfer, Design Controls, and Engineering Change processes.
• Experience with Change Control, CAPA, Deviations, Risk Assessments, and FMEA.
• Strong problem‑solving, technical documentation, and cross‑functional communication skills.

• Experience working with Contract Manufacturing Organizations (CMOs).
• Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and Design Control requirements.
• Experience with Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Familiarity with ERP systems (SAP, Oracle) and PLM systems.
• Experience supporting new product introductions and manufacturing readiness activities.