About this role
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%