Software Quality Engineer 2 - Medical Device

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POST DATE 9/8/2016
END DATE 12/19/2016

Smith & Nephew Pittsburgh, PA

Pittsburgh, PA
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Full Time
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Smith & Nephew Robotics develops computer assisted tools and technologies for more accurate and less invasive surgery. Less invasive surgical approaches require sophisticated technologies that can support a surgeon's decisions in the operation room.

As a Quality Assurance Engineer 2, you will be responsible for writing and executing system-level test procedures in order to verify performance to product specifications. You will have a high level of interaction with development engineers as you learn product functionality through review of requirements, design specifications, and engineering tests. You will develop tools and fixtures used to test product designs and perform product tests. Anomalies identified during testing will be entered into a problem tracking system, and you will document results of testing in test reports.


* Write system level test plans and procedures to verify performance to product requirement specifications.
* Perform and report system level testing to verify performance to product requirement specifications. Trace test results to requirements as part of documenting results.
* Facilitate software development phase activities through review of requirement specifications, tracing of requirement specifications to design specifications, and participation in design reviews as a quality assurance representative.
* Enter all anomalies identified during testing into a problem tracking system. Coordinate resolution of problem through interactions with others on the project team
* Develop hardware and software test tools (data, fixtures, and gages) for verification and validation testing. Validate test tools for use in product testing.
* Contribute to assessing risk of product design based on understanding of clinical use environment, product design and product operation.
* Evaluate post-launch proposed design changes to determine impact on requirement specifications, risk level, verification and/ or validation testing. Maintain requirement specifications and risk management documents in compliance with company procedures.
* Improve knowledge of design controls, risk management, testing, statistics, design verification / validation, domestic and international quality system regulations. Present the quality assurance / design controls perspective in project team interactions.