Principal Software Design Assurance Engineer – Structural Heart

Principal Software Design Assurance Engineer – Structural Heart

Requirements

• 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.

Responsibilities

• 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 agencies requirements.
• 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.

Preferred Qualifications

• Experience in developing and commercializing software products, including understanding of the software development lifecycle (SDLC) and best practices in the medical device industry, and experience in providing post product support.
• Experience with Cardiac imaging data analysis
• Experience in hands-on development and troubleshooting on targets using modern C++ 11 or greater.
• Experience in object-oriented design and design patterns.
• Demonstrated knowledgeable in scripting languages (e.g. PowerShell, Python, Bash) and relevant numerical libraries
• Understanding and appreciation of SDLC process and tools (e.g. JIRA, Bitbucket, Stash, Confluence, JAMA, Git, CMake.)
• Experience in software development in medical device industry or other regulated industry is preferred.
• Experience in the test-driven development methodology and unit test.
• Experience in Agile/Scrum/SAFe software development practices.
• Ability to distill software requirements from system requirements.
• Experience with Windows OS, QNX (x86 and/or Arm target), Linux and/or other Real Time Operating System, including related IDEs, SDKs, and DDKs.
• Experience performing risk management analysis of software ideally using JAMA
• Modeling and physics-based simulation experience is a plus
• Strong communication skills with a variety of audiences including programmers, marketers, physicians, and business leaders
• Self-starter and driver – able to execute effectively with strategic mindset.
• Proven leadership experience organizing and directing engineering teams
• Flexible and adaptable, comfortable working in a dynamic environment
• Cybersecurity experience is desirable