Principal Reliability Engineer – Software Quality

Description

Principal Reliability Engineer- Software Quality for Covidien, LP. Responsible for various software quality assurance functions during the Product Development Process (PDP) development lifecycle of complex medical devices to identify software problems and their causes in partnership with Software Developers and Testers. Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices. Coordinate Medical Device Product Development (MDPD) and SDLC (Software Development Life Cycle) including navigating complex government and industry regulations including FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304. Utilize the Association for the Advancement of Medical Instrumentation (AAMI TIR45) to understand and work with various programming languages ...

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