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%