Execute engineering tasks for product transfers or new product/process introductions, ensuring adherence to Stryker procedures and complete documentation.
Maintain the quality of processes and products as per operation and material specifications specific to the project.
Support the selection of components and equipment through evaluation of specifications, reliability, safety, and relevant regulatory requirements.
Contribute to capital acquisition activities, including specifying, installing, and validating equipment within project parameters.
Perform equipment analyses, conduct tests, and review results, participating in process review meetings.
Create PFMEA, Control Plans, Work Instructions, and related manufacturing documents for the project.
Develop PPAP and perform process capability studies for product transfers and launches.
Ensure GMP, safety compliance, conduct MSA studies, train manufacturing staff, and interact with global teams to meet project goals.
What you need-Required
Bachelor’s degree in an engineering discipline.
Minimum of 4 years of experience as Sr. Engineer on new product introduction or product transfer roles.
Experience in an FDA regulated or highly regulated industry.
Advanced level of English.
Preferred
Six Sigma Yellow belt or higher certification.
Experience in the Medical Devices industry.
Travel Percentage: 10%