As a Validation Engineer, your days will be varied as you tackle new challenges including:
- Ensure the quality of the medical device software and hardware meets the design requirements.
- Ensure design requirements are testable.
- Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation.
- Execute protocols/test scripts and document results.
- Generate and/or update summary reports.
- Participate in process improvements.
- Ensure compliance with FDA device regulatory requirements, including DHF and 510(k).
- Follow internal Standard Operating Procedures, including documentation of testing procedures.
- Using problem tracking software, report issues discovered during testing.
- Communicate with Hardware and Software Development, Marketing, Technical Services, and other project team members to ensure schedule