Principal Software Design Assurance Engineer - SH&A

Medtronic; Mounds View (MN); On-site; USD 124,000 - 188,000; Full time

Job summary

A leading company in health technology seeks a Principal Software Design Assurance Engineer in Mounds View, MN. This role involves ensuring software quality and compliance in medical device technology, leading innovative projects, and collaborating across teams. Candidates should have strong leadership skills, technical expertise in software lifecycle processes, and a commitment to improving patient outcomes through technology.

Benefits

Health, Dental and Vision Insurance

401(k) plan with employer contribution

Paid Time Off

Tuition assistance

Employee Stock Purchase Plan

Qualifications

• Bachelor's degree with 7 years of technical experience, or advanced degree with 5 years.
• Experience with software regulatory standards like IEC 62304, FDA QSR.
• Proficient in risk management and software verification/validation.

Responsibilities

• Lead quality and design aspects of software within the development lifecycle.
• Develop and validate software-related scripts for various applications.
• Conduct risk management activities including system risk analysis and FMEA.

Skills

Communication

Leadership

Risk Management

Software Development Lifecycle (SDLC)

Education

Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering

Tools

Python

MATLAB

JIRA

Job description

Principal Software Design Assurance Engineer - SH&A page is loaded

Principal Software Design Assurance Engineer - SH&A

Bewerben locations Mounds View, Minnesota, United States of America time type Full time posted on Vor 2 Tagen ausgeschrieben time left to apply Enddatum: 2. Juli 2025 (Noch 11 Tage Zeit für Bewerbung) job requisition id R35343 We anticipate the application window for this opening will close on - 2 Jul 2025

Bei Medtronic kannst Du eine Karriere für Dein Leben starten. Und Dich für ein gerechtes und innovatives Gesundheitswesen einsetzen, das für alle zugänglich ist. Du wirst zielstrebig Barrieren abbauen, die Innovationen in einer stärker vernetzten und solidarischen Welt im Wege stehen.

Ein Tag im Leben

Principal 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 offer 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 is in Mounds View, MN. within the Structural Heart and Aortic (SH&A) operating unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

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 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/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 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

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)

Physische Jobanforderungen

Die obigen Angaben sollen die allgemeine Art und das Niveau der Arbeit der Mitarbeitern in einer solchen Position beschreiben, es handelt sich aber dabei nicht um eine vollständige Liste aller für diese Position erforderlichen Aufgaben und Fähigkeiten.

Die im Abschnitt „Aufgaben“ dieser Stellenbeschreibung beschriebenen körperlichen Anforderungen sind repräsentativ für die Anforderungen, die ein Mitarbeiter erfüllen muss, um die wesentlichen Funktionen dieser Stelle erfolgreich auszuführen. Es müssen zumutbare Hilfsmaßnahmen unternommen werden, um Personen mit Behinderung die Ausübung der wesentlichen Funktionen zu ermöglichen. Für Bürotätigkeiten: Für die Ausübung solcher Tätigkeiten ist es erforderlich, dass der Mitarbeiter regelmäßig selbständig mobil ist. Der Mitarbeiter muss zudem mit einem Computer umgehen können sowie mit internen und externen Kollegen kommunizieren. Wenden Sie sich an Ihren Vorgesetzten oder an die örtliche Personalabteilung, um sich über eventuelle für die jeweilige Stelle spezifische Arbeitsbedingungen und körperliche Anforderungen zu informieren.

Leistungen und Vergütung

Medtronic bietet ein wettbewerbsfähiges Gehalt und ein flexibles Leistungspaket
Das Engagement für unsere Mitarbeiter ist der Kern unserer Werte. Wir schätzen die Beiträge jedes einzelnen. Sie tragen damit zu unserem Erfolg bei.Wir bieten für jede Karriere- und Lebensphase umfassende Leistungen, Ressourcen und wettbewerbsfähige Vergütungspläne.

Salary ranges for U.S (excl. PR) locations (USD):$124,800.00 - $187,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).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).

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 , and Simple 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) , and Capital 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 Leistungs- und Vergütungspläne

Über Medtronic

Wir sind weltweit führend im Bereich Gesundheitstechnologie und suchen und finden Lösungen für die drängendsten medizinischen Probleme der Menschheit.
Unsere Mission, Schmerzen zu lindern, die Gesundheit von Patienten wiederherzustellen und ihr Leben zu verlängern, eint ein weltweites Team von mehr als 95.000engagierten Mitarbeitern.

Im Herzen sind wir Ingenieure, die ehrgeizige Ideen umsetzen, um echte Lösungen für echte Menschen zu entwickeln. Ob im Labor, in der Fabrikhalle oder im Konferenzraum– jede*r von uns experimentiert, schafft, baut, verbessert und löst Probleme. Mit unseren Kompetenzen, den unterschiedlichen Perspektiven und unserem Pioniergeist sind wir dazu berufen, Außergewöhnliches zu schaffen.

• Erfahren Sie mehr über unser Engagement für Diversität und Inklusion unter

Einer unserer Grundsätze ist gleiche Beschäftigungschancen für alle, unabhängig von Alter, Hautfarbe, nationaler Herkunft, Staatsangehörigkeit, Behinderung, Rasse, Religion, Glauben, Geschlecht, sexueller Orientierung, Geschlechtsidentität und/oder -ausdruck, Erbinformationen, Familienstand, Status in Bezug auf öffentliche Unterstützung, Veteranenstatus oder anderer durch staatliche, regionale oder lokale Gesetze unter Schutz gestellten Eigenschaften. Darüber hinaus trifft Medtronic angemessene Vorkehrungen für qualifizierte Personen mit Behinderungen.

Medtronic veröffentlicht die meisten Stellen 3 bis 7 Tage lang auf der Karriereseite.

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