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 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.

Qualifications

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelors degree required in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a related technical field.
• Minimum of 4 years of technical experience, or advanced degree with 2 years of technical experience.

Nice to Have

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

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.

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. For Office Roles: 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 and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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. For Office Roles: 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, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - 147,600.00

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.