As a Principal Software Product Owner at Medtronic, you will be a key leader in our R&D efforts, guiding Scrum Teams through the entire Software Development Life Cycle (SWDLC) for complex medical devices, all while adhering to IEC 62304 standards. You'll act as the voice of the customer, balancing stakeholder inputs, prioritizing backlogs, and ensuring the delivery of high-value software solutions. This role is crucial for aligning product strategies with business needs, fostering cross-functional collaboration, and championing innovation in a highly regulated environment to ultimately improve patient lives.
A Day in the Life
You will drive software product vision and execution by:
- Leading Scrum Team(s) through the SWDLC for medical devices, diligently following IEC 62304 standards.
- Collaborating with diverse stakeholders and cross-functional teams to prioritize team work based on critical business needs.
- Leading the prioritization and refinement activities for your team's backlog(s), ensuring alignment with strategic goals.
- Determining and prioritizing features, enhancements, and fixes based on user feedback, thorough market analysis, and demonstrated business value.
- Collaborating extensively with stakeholders to gather input, provide transparent updates, and align product strategies with their needs and expectations.
- Acting as the voice of the customer to the Scrum team(s) in various SAFe/Agile sprint meetings, championing and supervising value-focused user stories, and meticulously determining the Definition of Done/acceptance criteria.
- Balancing and driving consensus on inputs from multiple stakeholders, anchoring priorities firmly in direct user research.
- Observing usability testing and OR (Operating Room) procedures to gain deep customer insights.
- Participating actively in Risk Assessment and requirements development processes.
- Engaging in cross-functional collaboration with manufacturing and production teams to ensure seamless product realization.
- Participating in the documentation of the software, including architecture and design details, unit testing, anomaly tracking, and reports.
- Collaborating with HW and systems partners, including integration teams, testing teams, Quality, and System V&V, to ensure holistic product development.
Required Knowledge and Experience
- Bachelor's degree in a technical discipline: Electrical Engineering, Computer Engineering, Computer Science, Biomedical Engineering, or related fields.
- Preferred: Master's or Ph.D. degree in a related discipline.
- Minimum of 12 years of relevant experience with a Bachelor's degree, or a minimum of 10 years of relevant experience with an advanced engineering degree.
- At least 3 years of experience as a Product Owner or Product Manager working on complex products.
- Experience leading multiple teams as a Product Owner.
- Experience leading distributed teams as a Product Owner.
- Formal Scrum/SAFe certification and experience.
- Experience working on hybrid Hardware/Software products using a scaled agile framework (any).
- Familiarity with object-oriented design and modern programming languages, with a preference for C++, Python, or Simulink.
- Previous hands-on experience in developing, debugging, and troubleshooting software issues.
- Experience in software architecture design, writing design documents, and creating flowcharts, layouts, diagrams, and charts.
- Understanding and appreciation of SDLC (Software Development Life Cycle) processes and tools (e.g., JIRA, Bitbucket, Stash, Confluence, JAMA, Git, CMake).
- Good understanding of software concepts and the Software Development Life Cycle (SDLC) using IEC 62304.
- Experience independently managing and prioritizing design approaches for multiple projects (e.g., consultancy) or complex systems (e.g., medical systems), including experience with timelines and budgeting.
- Ability to distill clear software requirements from system requirements.
- Experience working with highly regulated environments and a strong appreciation for the discipline required to develop software in such industries.
- Experience working with medical devices and regulations such as ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as a Medical Device, and IEC 62304.
- Experience performing risk management analysis of software, ideally using Software FMEA (Failure Mode and Effects Analysis).
Nice to Haves
- Experience in software development in the medical devices industry is a big plus.
- Experience or basic understanding of surgical robotics is a plus.
