Abiomed
Sr. Software Manual Test Engineer
Job#: 17EG-25
Positions: 1
Posted: 01/20/2017
Job Type:
Location: Danvers, MA
Department: Engineering
Salary: Commensurate with Experience
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Job Description
<p> ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.</p> <p> The <strong>Sr. Software Test Engineer </strong>provides effective, relevant, and well-documented V&amp;V activity that is compliant with medical-device regulations and serves as a key contributor within the Software organization. The <strong>Sr. Software Test Engineer </strong>will be responsible for testing requirements and the execution of test cases for our leading edge cardiac support and assist devices.</p> <p> <strong>Primary Duties and Responsibilities: </strong></p> <ul> <li> Typical V&amp;V activities include (but not limited to), analyzing system requirements, test case design, integration testing, defect definition and troubleshooting, writing verification reports and generating analytics.</li> <li> Analyze design requirements; provide feedback on content, clarity, scope, capability, accuracy, completeness and testability.</li> <li> Create technically robust test cases following best practices, that when executed fully exercises the system and provide clear and traceable object evidence.</li> <li> Design tests that expose hazard conditions and exercise risk mitigations.</li> <li> Identify defects in software; correlating to features, functionality, reliability, robustness and compliance to regulatory requirements and standards as define for Class III medical devices.</li> <li> Write and produce documentation that is clear, concise, and comprehensive.</li> <li> Produce integration protocols, regression strategies, and other VRR / End-Game test activities.</li> <li> Generate trace matrices, test evidence and formal documentation for final submissions.</li> <li> Support and participate in automated testing efforts and test tool designs.</li> <li> Establish procedures that support FDA and IEC guidance documents</li> <li> Act as a liaison to adjoining engineering teams as well as be an advocate in disparate groups</li> <li> Enhance current test practices and implement new ones</li> </ul>



Skills/Requirements
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Requires a degree in Computer Science or directly related scientific or engineering discipline</li>
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Typically requires a BS Degree with a minimum 5-8&nbsp; years in a software quality assurance / verification environment or 3-5 years&rsquo; experience with a Master&rsquo;s Degree in a software quality assurance / verification environment</li>
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Desire and aptitude to coach, teach, and mentor junior engineers</li>
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Experience in an Agile environment, and an understanding of the V-model SDLC.</li>
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Experience using simulators, waveform generators, analyzers, and other test condition injectors.</li>
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Experience with testing algorithms a plus.</li>
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Experience testing embedded systems and RTOS software a plus</li>
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Experience with safety-critical or medical products.</li>
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Experience with C programming, Python scripting, and BDD a definite plus.</li>
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Knowledge of any of the following: IEC 60601, 62304, 62366, FDA21 FDA CFR 820.30, and ISO 14971</li>
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<p>
<strong>ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.&nbsp; We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.</strong></p>
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