Desired Skills and Experience
- Set up and maintain a strong relationship with development, validation, service and manufacturing stakeholders and to manage their perception
- Tests software and hardware requirements for a Medical Device
- Performs Verification and Validation testing in an FDA regulated environment
- Performs laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations
- Executes test protocols
- Execution of system level tests both functional and non-functional (e.g. reliability, performance, environmental, etc.) including design, preparation and implementation of tests
- Reports and documents test results in test reports and enters defects and issues into the defect tracking system - monitors and updates defects as needed including defect closure
- Reviews requirements in system and sub-system-level requirement specifications for consistency and testability and translates them into test cases
- Supports the test estimation, planning and risk management activities
- Follows the improvements in the profession of test engineering
- Ability to write and edit technical documents such as test protocols and technical reports
- MSc or BSc degree in computer science, electronics, electrical, mechanical engineering and with a broad technical understanding and interest in medical devices
- Have a pragmatic, creative, flexible attitude with a result driven, can-do mentality
- Advanced knowledge of scientific principles and concepts
- Medical Device/Instrumentation engineering experience is desirable
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