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.
Are you an engineer with a passion and talent for software testing? Do you get a charge identifying defects and deficiencies in software, and the satisfaction that comes in making good software – great? Are you the detail-oriented type, often finding things that others overlook? Can you interpret product requirements, understand engineering specs and from them write test procedures that are logical, precise and thorough? If you answered ‘Yes’, and you have a desire to make a true impact on patient health – then we want to hear from you! Discover your full potential with Abiomed®, where you will develop professionally, and contribute to a company imagining the future of heart care.
Primary Duties and Responsibilities:
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Read, analyze and comprehend product requirements and engineering specifications.
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Provide clear feedback (redlines), on content (clarity, accuracy, completeness and testability).
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Develop test procedures that support and prove out product and engineering requirements.
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Design test procedures after analyzing product risks/hazards and for their identified mitigations.
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Execute hands-on black-box style testing utilizing well known methodologies.
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Produce documentation that adheres to FDA quality regulations for medical devices (CFR 21, Part 280).
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Test and identify defects in the system, enter and track them. Ensure they are resolved.
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Help drive the product development phases by continually improving test processes.
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Write regression strategies, integration procedures and other end game test activities.
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Generate trace matrices, formal test evidence and other documentation for final submissions.
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Support and participate in automated testing efforts and test tool designs.
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Establish procedures that support FDA and IEC guidance documents.
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Attend and represent V&V at engineering and other company meetings.
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