Senior Software Verification and Validation Engineer - Strategic MPC Eden Prairie, MN

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Senior Software Verification and Validation Engineer

The Senior Software Verification and Validation Engineer is a key member of the software development team, responsible for developing verification and integration testing software across a global product portfolio, including digital health platforms and medical devices. As part of the global R&D software engineering team, this role involves active participation in all phases of the software development lifecycle, focusing on verification, validation, and integration testing of medical devices and connectivity solutions. The position applies expertise in software testing to translate product requirements into comprehensive test strategies, ensuring all documentation complies with a regulated Product Development Process (PDP) and Quality Management System (QMS).

• Develop innovative solutions aimed at reducing total cost of ownership (TCO) for customers, improving workflow efficiency, and enhancing visibility into enterprise contrast administration and medical device intelligence.
• Lead software testing efforts for OEM connectivity and/or medical devices.
• Design and develop test protocols to verify and validate software functionalities based on specified requirements.
• Collaborate with software architects, integration engineers, and systems engineers to ensure that the software architecture is prepared for verification and validation, considering potential hazards and customer requirements.
• Design, develop, test, maintain, and document testing components, applications, scripts, and tools.
• Participate in product development stages such as requirements review, architecture design, usability testing, risk assessment, and test execution.
• Foster a culture of engineering excellence with a strong commitment to quality.
• Provide input to requirements development and create a comprehensive software test strategy and integration plan.
• Develop automated and semi-automated testing software.
• Prepare and document test reports that detail the results of both formal and ad-hoc testing, ensuring all requirements are adequately covered.
• Contribute to project teams by estimating effort and determining resource requirements.
• Collaborate with third-party vendors to develop testing strategies for medical device interoperability solutions, such as those adhering to IHE standards.

• Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a related field.
• At least 5 years of software development and testing experience.
• 2+ years of experience writing test scripts.
• Proficiency in a scripting language (e.g., Python).
• Strong problem-solving and leadership skills.
• Competence in developing and integrating software components for testing.
• Excellent communication skills for effective collaboration with R&D, Quality, and Program Management teams.

• Master's degree in a relevant field (Computer Engineering, Software Engineering, Electrical Engineering).
• 5+ years of experience working with C#.
• 2+ years of Python programming experience.
• Knowledge of QSR, ISO/EN, and other quality system standards.
• Familiarity with healthcare protocols such as DICOM, HL7, IHE, and/or FHIR.
• Experience in test automation, including GUI, integration, and reliability testing, as well as the development of test automation frameworks.
• Proficiency in development tools like MS Visual Studio, Jira, and git.
• Familiarity with CI/CD pipeline tools such as Jenkins or Azure DevOps.
• Understanding of clinical radiology terminology.
• Experience with medical device interoperability, including HL7, DICOM, PACS, and HIS/RIS systems.
• Proficiency in developing testing mechanisms for device-based software with scalability for cloud-hosted applications.
• Demonstrated experience in testing medical device cybersecurity measures.
• Background in the development and testing of critical care medical devices.
• Experience in medical device connectivity and drug delivery systems.
• Proven ability to test complex systems and work with global, multi-disciplinary teams.
• Skilled in analyzing experimental, ad-hoc, reliability, and performance data.
• Ability to create testing frameworks for cloud architectures, including application development, identity and access management, network management, and data management.
• Responsible for ensuring that design inputs are effectively translated into "tested " design outputs.

• Adherence to all policies, procedures, and business ethics codes.
• Ability to travel up to 10% of the time.