Staff Manufacturing Engineer

About the role

Join a team dedicated to establishing new manufacturing capabilities in Costa Rica by transferring a product from an international site. You will support process transfer, validation, production readiness, and continuous improvement in a highly regulated medical device environment.

Key responsibilities

• Lead manufacturing process transfer activities from international sites into production.
• Develop and execute process, equipment, and packaging validation protocols in compliance with quality and regulatory requirements.
• Analyze manufacturing performance data and implement improvements to enhance quality, efficiency, and reliability.
• Support manufacturing builds and production readiness for new product launches.
• Investigate production issues and apply corrective actions using structured problem‑solving methods.
• Collaborate with Quality, Operations, Supply Chain, and R&D to achieve project goals.
• Create and maintain technical documentation such as process reports, risk assessments, drawings, and validation records.
• Train manufacturing personnel on new and existing processes and provide technical support.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years of medical device manufacturing experience.
• Experience with medical device process transfer projects and manufacturing validations.
• Familiarity with ISO requirements, FDA regulations, and design control processes.
• Advanced English proficiency, both written and verbal.
• Valid passport and eligibility to travel internationally.

Required skills

• Manufacturing process transfer
• Process and equipment validation
• Data analysis for manufacturing performance
• ISO and FDA regulatory compliance
• SAP or similar ERP systems