At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Senior Software Design Assurance Engineer

Careers that Change Lives

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. This is an exciting opportunity to join the Structural Heart and Aortic R&D team and lead the engineering organization in the strategic development of software incorporated in clinical sizing applications and other Artificial Intelligence (AI) and Machine Learning (ML) technology. The Engineer will be responsible for software related technology development strategy, engaging with cross-Medtronic partners and leading a team of engineers to create tools to accelerate innovation to advance care of patients. The successful candidate will have a mastery of the SiMD and SaMD regulatory landscape and the ability to connect the clinical and business needs to innovation potential. As a Senior Software Design Assurance Engineer you will collaborate with cross functional teams to design, implement, and test software applications to Product Development Projects.

Excellent interpersonal skills and communication skills are a must. Overall responsibility will be for software applications risk management and design verification/validation testing for SH&A operating units. Demonstrated strong leadership to guide the team navigating SiMD/SaMD regulatory landscape, in combination with training and mentorship opportunities.

Key Technologies:

Evolut™ PRO and PRO+ TAVR systems
Melody™ Transcatheter Pulmonary Valve
Harmony™ Transcatheter Pulmonary Valve
Intrepid™ Transcatheter Valve System
Endurant™ II/IIs AAA Stent Graft System
Valiant Captivia™ Thoracic Stent Graft System
Heli-FX endoanchor system

This position can be 100% remote and is within the Structural Heart and Aortic (OSH-SHA) operating unit.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply to the Senior Software Design Assurance Engineer role.  This includes, but is not limited to the following:

• 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