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Principal Software Quality Engineer

Seeking a Principal Software Quality Engineer to lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation) and other global regulatory agency requirements. Position Responsibilities: Lead quality focused design and development of software within the software development lifecycle by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. Develop test strategies, review test designs, and validate test scripts, verification of software for Transcatheter Valve Implant Sizing application, including cybersecurity requirements. Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals. Develop and validate software related scripts using Python / MATLAB for Finite Element Analysis, clinical imaging, Structural Integrity (Fatigue) testing and other design modeling applications. Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety. Provide Software (SW) risk management technical leadership to Design Quality Engineering peers. Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/IEC82304-1/HIPAA/FDA/Security Standards/Cybersecurity/Data Privacy). Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results, verification and validation reports. Review software systems design, change specifications, and plans against contractual and/or process requirements. Provide guidance, coaching and training to other employees within job area. Required Knowledge and Experience: Requires a Bachelors degree required in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a technical field. Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience.