Staff Manufacturing Engineer – Medical Device Production

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 lead process transfer, validation, and production readiness activities 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.

Required profile

• 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 and manufacturing validations.
• Familiarity with ISO requirements, FDA regulations, and design control processes.
• Advanced written and verbal English proficiency and a valid passport for international travel.

Required skills

• Process transfer and scale‑up expertise.
• Manufacturing validation and qualification knowledge.
• Regulatory compliance (ISO, FDA).
• Use of SAP or similar ERP systems.
• Technical documentation creation (process reports, risk assessments, validation records).