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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>
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The <strong>Sr. Software Test Engineer </strong>provides effective, relevant, and well-documented V&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>
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<strong>Primary Duties and Responsibilities: </strong></p>
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Typical V&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>
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Analyze design requirements; provide feedback on content, clarity, scope, capability, accuracy, completeness and testability.</li>
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Create technically robust test cases following best practices, that when executed fully exercises the system and provide clear and traceable object evidence.</li>
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Design tests that expose hazard conditions and exercise risk mitigations.</li>
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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>
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Write and produce documentation that is clear, concise, and comprehensive.</li>
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Produce integration protocols, regression strategies, and other VRR / End-Game test activities.</li>
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Generate trace matrices, test evidence and formal documentation for final submissions.</li>
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Support and participate in automated testing efforts and test tool designs.</li>
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Establish procedures that support FDA and IEC guidance documents</li>
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Act as a liaison to adjoining engineering teams as well as be an advocate in disparate groups</li>
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Enhance current test practices and implement new ones</li>
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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 years in a software quality assurance / verification environment or 3-5 years’ experience with a Master’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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<strong>ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. 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>