Design Assurance Engineer 1 CR (Temporary 12 months)

Alajuela, Costa Rica

Design Assurance is the disciplined engineering process of assuring the requirements, qualification process and results are done in the proper way for the desired goal. Provide design assurance support for on market medical devices. This role will be responsible to facilitate the application of design controls while supporting manufacturing and design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

+ **Education / Educación:**
+ Bachelor’s degree in life sciences, engineering, or related discipline.

+ **Specialized Knowledge (Desirable) / Conocimiento especializado (preferable):**
+ Familiarity with FDA Quality System Regulations, especially Design Control requirements
+ ISO 13485
+ Medical Device Directive
+ EU Medical Device Regulation.

+ **Languages ​​required for...