We anticipate the application window for this opening will close on - 19 Mar 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

Principal Software Quality Engineer

Careers that Change Lives

Transforming hypertension treatment, Renal denervation for hypertension!
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.
Medtronic Coronary & Renal Denervation (OHS) Operating Unit develops the next generation medical technologies that alleviate pain, restore health, and extend life for millions of patients across the world.

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 Principal Software Quality Engineer – Released Product Engineering 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 medical device software maintenance releases and feature enhancement activities.

This position is in Mounds View, MN within the Coronary & Renal Denervation (CRDN) Operating Unit and requires on-site presence four 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 the Life:

This role requires strong technical and leadership skills to support the embedded software for a class 3 medical device within the CRDN Group. The Principal Software QA Engineer – Released Product Engineering will apply advanced knowledge of software design controls, risk management, and regulatory standards to assess and mitigate potential software risks and ensure successful compliance with IEC62304, ISO 14971, ISO 13485, FDA, EUMDR and other regulations. They will work closely with cross-functional teams to review design documentation, guide the product development team on process compliance in building a safe and effective medical device. Additionally, the Principal Software QA Engineer – Released Product Engineering will support system risk assessments as a software SME, review software verification and validation (V&V) activities, and provide expert input on software change management, supporting the development of safe and effective medical devices that improve patient outcomes.

In general, the following responsibilities apply for the Principal Software Quality Engineer – Released Product Engineering role. This includes, but is not limited to the following:

Software Quality Subject Matter Expert (SME)

• Serve as the Software Quality assurance SME, embedding compliance and regulatory excellence into the ongoing support and improvement of embedded and cloud-based software systems, prioritizing patient safety and product quality post-launch.
• Lead software quality assurance activities in the post-market phase for complex electro-mechanical medical devices, collaborating with Software Developers and Testers to meet regulatory and performance standards.
• Conduct post-market risk assessment and review software FMEAs, identifying and mitigating risks to ensure patient safety and regulatory adherence, in line with FDA post-market guidance.
• Accountable for the identification and monitoring of software quality, Design for Reliability and Manufacturability (DRM), and software-related complaint metrics.

Design Compliance Oversight

• Review / support essential software documentation update, including released product requirement updates, test protocols, verification/validation plans, reports, and software design history files.
• Ensure software traceability matrices remain current and compliant with ISO 13485, IEC 62304, IEC 82304 and FDA standards, incorporating any post-market changes.
• Lead quality improvement initiatives to enhance post-market software quality processes and methods, ensuring adherence to standards like HIPAA, ISO 13485, and IEC 82304.
• Collaborate with R&D and Product Risk teams to implement best practices in software security and safeguard patient data and product integrity post-launch.
• Review Software updates and patches comply with regulatory standards, ensuring performance and reliability.
• Support global teams, including US and European-based software teams, ensuring international regulatory compliance and addressing post-market issues.

Risk and Failure Mode Effect Analysis (FMEA)

•     Support system risk analysis and software Failure Modes and Effects Analysis (FMEAs), identifying and mitigating risks to ensure patient safety and compliance expectations.

Problem Resolution Management

• Investigate and resolve post-market software-related complaints with a focus on root cause analysis (RCA) , Issue Impact Assessment (IIA), Corrective and Preventive actions (CAPA).
• Stay informed on emerging regulatory developments, enhancing post-market software quality processes, methodologies and best practices.
• Participate as a member of the Issue resolution board, managing post-design freeze changes to ensure compliance and traceability.
• Plan and independently schedule activities to meet key project milestones and timelines.

The successful candidate will have:

• Practical application of regulations and standards to guide agile, iterative product development teams through the complexities of design controls and risk management.
• Strong analytical and problem-solving skills with keen attention to detail and a proactive mindset, ensuring software quality and patient safety in complex hardware/software systems.
• Demonstrated ability to collaborate with global, cross-functional teams in a fast-paced environment, communicate technical concepts clearly, and ensure stakeholder alignment.

#CRDN #HypertensionTherapy

Qualifications-

MUST HAVE - MINIMUM REQUIREMENTS:

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

• Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
• Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience

Nice to Have

• Certification such as ASQ Certified Software Quality Engineer (CSQE) or equivalent is a plus.
• Experience in SDLC environments using ALM tools (PTC Codebeamer, Atlassian Suite, Polarion), defect tracking tools (Jira), and CI/CD tools (Gitlab, Jenkins).
• Proficiency in software systems engineering and quality assurance policy and procedure development.
• Contribution to IEC standards, FDA guidance draft reviews

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):$119,200.00 - $178,800.00

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.