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The Design Quality Assurance Engineer interacts with development engineers to assure quality in design for medical devices, applications, and embedded software, aligned with domestic and international regulations. In this position you review hardware and software design input requirement specifications and interact with engineering staff to document design specifications and tests. With limited oversight, you will create and update risk assessments; coach engineers in completing FMEA analysis of hardware and software elements; review verification and validation test plans, test procedures, and test reports; and you will monitor progress to resolve anomalies in a bug tracking system. You will advise on completing product requirements, risk controls, design reviews, specification traces, verification / validation testing, and issue tracking; work with staff on validation methods that maintain compliance with regulations and standards; advise on use of quality assurance methods in development, release, and maintenance of medical device hardware and software used in testing and service functions.