Principal Software Design Assurance Engineer - Structural Heart

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

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 Principal Software Design Assurance 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 Principal 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.

In general, the following responsibilities apply to the Principal 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/SecurityStandards/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.

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 technical field.
• Minimum of 7 years of technical experience,
• Or advanced degree with 5 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

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.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

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 95,000+ 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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findherea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.