Careers That Change Lives A Day in a Life Together, we can change healthcare worldwide. At Medtronic, We push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This engineering position requires high level technical and leadership skills to advance the development of innovative system solutions in support of the business roadmap. We are looking for individuals who have a background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation. The engineer will apply technical principles, theories, and new concepts to collaboratively solve technical problems. Under direction of the Manager, this position is responsible for leading the design, development, documentation and execution of system verification & validation plans, schedules, test protocols and reports to ensure products meet published specifications and are compliant with Quality System Regulations. We are seeking a highly skilled and experienced Senior Software Systems Verification and Validation Engineer to join our team. The successful candidate will play a key role in ensuring the quality and reliability of our medical device software systems through rigorous systems verification and validation activities. They will collaborate with cross-functional teams to verify and validate complex software and hardware systems, ensuring compliance with regulatory standards and industry best practices. Position Responsibilities ? Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively. ? Develops approach & authors System Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage. ? Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan. ? Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts. ? Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers cross-functionally (different departments) to achieve results. ? Authors design verification and design validation protocols and reports. Executes system verification and validation activities. ? Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study. ? Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study. ? Plan and execute Test Method and Non-product validations (spreadsheet, software, etc.), and equipment and tooling qualification, per project needs. ? Monitors progress of assigned tasks to defined project schedule. ? Monitors and mentors Associate System Engineers as required. ? Produce high quality deliverables while complying with relevant SOP. ? Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval. ? Develop and execute comprehensive System software verification and validation plans, protocols, and test cases. ? Perform System Software verification and validation activities for complex software and hardware systems, ensuring compliance with regulatory requirements, including IEC 62304. ? Conduct manual and automated software tests, analyze test results, and generate detailed reports. ? Collaborate with development teams to identify and resolve software issues, ensuring software reliability and functionality. ? Participate in risk assessment and mitigation activities, applying structured problem-solving methods and tools. ? Ensure compliance with design control processes, including maintenance of design documentation and traceability. ? Collaborate with cross-functional teams, including software engineering, hardware engineering, and quality assurance, to drive effective System V&V activities. ? Stay up-to-date with industry trends and best practices in software verification and validation for medical devices. ? Contribute to continuous improvement efforts, including the development and implementation of robust design practices, such as DFSS, DFLS, and DRM. ? Travel requirement: Less than 10% Must Have: Minimum Requirements ? Bachelor's degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Software Engineering, or other Technical Discipline. ? 8+ years of relevant experience in Software Systems Engineering Verification and Validation. ? 6+ years of experience in medical device product development, or 2 years of experience with an MS degree. ? Strong knowledge of software verification and validation principles and practices. ? Experience working in a regulated industry, preferably in medical devices. ? Familiarity with Medical device IEC 62304 and other relevant regulatory standards. ? Excellent critical thinking and problem-solving skills. ? Strong written and oral communication skills, with the ability to summarize complex technical concepts concisely. ? Strong collaboration and influence skills, with the ability to work effectively in cross-functional teams. ? Experience with automated and/or manual software tests. ? Knowledge of robust design practices such as Six Sigma DFSS Nice to Have: ? Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications PHYSICAL JOB REQUIREMENTS: The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ? While performing the duties of this job, the employee is regularly required to be independently mobile. ? The employee is also required to interact with a computer for extended periods of time, and communicate with peers and co-workers. ABOUT MEDTRONIC: Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let?s work together to address universal healthcare needs and improve patients? lives. Help us shape the future.