- Location
- Alajuela, Grecia Evolution Free Zone Building 2, Costa Rica
- Workplace
- Onsite
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Experience
- 5+ years
- Source
- Workday
Description
Work Flexibility: Onsite
Travel Percentage: 20%
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%
Skills
SAPFDACompliance