Global Process Transfer Engineer – Medical Devices

Stryker; Town of Greece (NY); On-site; USD 110,000 - 150,000; Full time

Job summary

Stryker is seeking a qualified professional to lead manufacturing process transfer activities from international sites into production, ensuring validation and regulatory compliance across ISO and FDA requirements.

The role involves collaboration with Quality, Operations, Supply Chain, and R&D teams to drive production readiness for new product launches and continuous improvement through data-driven problem solving.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum 5 years of medical device manufacturing experience.
• Experience supporting medical device process transfer projects.
• Experience with ISO requirements, FDA regulations, and design control processes.
• Willingness to travel internationally.

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 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 R&D 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.

Skills

Process transfer

Cross-functional collaboration

Problem solving

Advanced English

Documentation

Education

Bachelor's degree in Engineering

Tools

SAP

Job description

Stryker is seeking a qualified professional to lead manufacturing process transfer activities from international sites into production, ensuring validation and regulatory compliance across ISO and FDA requirements.

The role involves collaboration with Quality, Operations, Supply Chain, and R&D teams to drive production readiness for new product launches and continuous improvement through data-driven problem solving.