Perform engineering verification testing in a dynamic Medical Device Research and Development environment. This is a high visibility role with a significant direct impact on the successful development of a new medical device. Activities will include: determining test coverage for revisions to design. Writing test procedures, and other activities involving durability and reliability assessments. Performing tests, documenting test results, and assessing Pass/Fail outcomes. Identifying and noting non-conformance or unexpected outcomes. Receive input from design engineers regarding design intent and test methods. Provide feedback to design engineers regarding design capability
Background Required: Bachelors Degree in an engineering discipline. Experience in Medical devices, knowledge of FDA’s Quality System Regulations (QSR’s), ISO 13485 and other medical device industry experience a plus.
ENTEGEE Engineering Technical Group