Staff Manufacturing Engineer (Grecia, Manufacturing Site)
Job description
Work Flexibility: Onsite Join a team focused on bringing new manufacturing capabilities to Costa Rica through the transfer of a product from an international site. In this role, you will support manufacturing process transfer, validation, production readiness, and ongoing process improvement activities while working in a highly regulated medical device environment.
This position offers the opportunity to collaborate with global teams and support the successful launch of new manufacturing lines.
What You Will Do
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 process improvements to enhance quality, efficiency, and reliability.
Support manufacturing builds and production readiness activities for new product launches. Investigate production issues and implement corrective actions using structured problem-solving methodologies. Collaborate with cross-functional teams including Quality, Operations, Supply Chain, and Research & Development to support project objectives.
Create and maintain technical documentation including process reports, risk assessments, drawings, and validation records. Train manufacturing personnel on new and existing processes and provide technical support to sustain production operations.
What You Will Need
Required Qualifications Bachelor’s degree in Engineering or a related technical field. Minimum 5 years of medical device manufacturing experience. Experience supporting medical device process transfer projects. Experience with manufacturing validations and process qualification activities. Experience working with ISO requirements, FDA regulations, and design control processes.
Advanced English proficiency, written and verbal. Valid passport and eligibility to travel internationally.
Preferred Qualifications
Experience with manufacturing process scale-up and new product introduction activities. Experience using SAP or similar enterprise resource planning systems. Travel Percentage: 20%
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