Senior Software QA Engineer - Digital Health -CRDN (Finance)

We anticipate the application window for this opening will close on - 23 May 2025

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 Quality Engineer

Careers that Change Lives

Transforming hypertension treatment, Renal denervation for hypertension!

This is a Software Design Assurance role focused on regulatory compliance, design control, and risk management for SaMD and digital health; not a traditional QA Software test execution position. Ideal for quality engineers passionate about driving innovation through systems and establishing process compliance.

Join Medtronic's Coronary & Renal Denervation (CRDN) team, where we're transforming hypertension treatment with cutting-edge digital health and energy-based medical technologies. Be part of a mission-driven organization committed to alleviating pain, restoring health, and extending life.

Our Symplicity Spyral™ Renal Denervation (RDN) System represents the future of hypertension therapy. Now, we're expanding into Digital Health with Software as a Medical Device (SaMD) and AI-powered solutions-and we want innovative minds to help lead the way.

Treatments We Offer:

Renal Denervation

Key Technologies

Symplicity Spyral™ Renal Denervation (RDN) System

Medtronic's Coronary and Renal Denervation (CRDN) business is looking for a Senior Software Quality Engineer to be part of a high-performing team that is revolutionizing the design and development of energy based therapeutic medical devices to treat hypertension. In this role, you will leverage both your technical breadth and business acumen to support the newly approved Hypertension therapy software as medical device (SaMD) and participate in the design and development of next generation medical devices.

This position is in Mounds View, MN within the Coronary & Renal Denervation (CRDN) Operating Unit and requires on-site presence three days a week.

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 Life:

As a Senior Software Quality Engineer - Digital Health, you'll provide quality engineering leadership for web, mobile, and AWS-based cloud applications, including SaMD platforms. You will ensure compliance with global regulatory standards, manage risk and cybersecurity, and champion software quality throughout the development lifecycle.

You'll collaborate closely with R&D, Regulatory Affairs, and Systems Engineering to deliver reliable, secure, and compliant digital health solutions.

In general, the following responsibilities apply for the role. This includes, but is not limited to the following:

• Software Design Assurance Leadership - Provide technical leadership in software quality engineering for Digital Health (DH) and Software as a Medical Device (SaMD) product within the Coronary and Renal Denervation (CRDN) business.
• Regulatory Compliance & Standards - Ensure compliance with global medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and applicable AI/ML regulations.
• Risk Management & Cybersecurity - Lead software risk management activities per ISO 14971 and IEC 81001-5-1, ensuring robust hazard analysis, risk controls, and cybersecurity measures for DH/SaMD solutions.
• Software Development Lifecycle (SDLC) Oversight - Provide quality oversight for software development, verification, validation, and release activities, ensuring adherence to Medtronic's design control processes.
• AWS-Based Web & Mobile Application Assurance - Drive software design assurance activities for AWS-based cloud applications and mobile apps, ensuring compliance with software development best practices, cloud security, and regulatory requirements for SaMD.
• Design Control & Quality Engineering - Ensure rigorous software design control activities, including requirements review, design verification, validation planning, and defect tracking, to enhance software quality and reliability.
• Digital Health & AI/ML Assurance - Support assurance activities for AI/ML-enabled medical software, ensuring proper data integrity, algorithm validation, and continuous learning risk controls.
• Process Improvement & QMS Enhancements - Contribute to the advancement of Medtronic's Software Quality Management System (QMS), focusing on process efficiency, compliance, and best practices in digital health.
• Audits & Compliance Readiness - Support internal and external audits (e.g., FDA, Notified Body, MDSAP), ensuring software quality documentation and evidence meet regulatory expectations.
• Training & Mentorship - Act as a subject matter expert (SME) in software quality, providing training and mentorship to engineers and stakeholders on best practices in SaMD, cloud-based software quality, and digital health applications.

Qualifications

MUST HAVE - MINIMUM REQUIREMENTS:

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

• Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
• Minimum of 4 years of technical experience, or advanced degree with 2 years of technical experience

Nice to Have

• SaMD, cloud-based medical software, mobile health apps
• Health Software
• Design Control / Design Assurance
• Risk Management, traceability, requirements reviews
• Verification & Validation Oversight (not test execution)
• Audit support, regulatory submissions, technical file reviews
• QMS or Quality Engineering experience in regulated environments

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 accommodation 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):$102,400.00 - $153,600.00

This 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 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 find here a 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.