Software Quality Engineer Jobs at Medtronic with Visa Sponsorship

INTRODUCTION

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

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’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Open to our Newton, MA or Mounds View, MN offices.

Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to support design, development, and maintenance of software for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.

PRIMARY RESPONSIBILITIES

• Acts as the Software Quality Core Team Member (QCTM) and program level Software Quality lead for assigned software and software-enabled product development programs, with accountability for software quality strategy, execution, and outcomes across the full product lifecycle.

• Plans, directs, and oversees all Software Quality aspects of design and development for assigned products, ensuring compliance with Medtronic policies, global regulatory requirements, and applicable quality system and software lifecycle regulations (e.g., IEC 62304, ISO 14971, FDA software guidance).

• Leads and integrates Software Quality program planning, including software lifecycle strategy, software design control approach, verification and validation strategy, cybersecurity and data integrity considerations, risk management planning, release readiness, and post market software quality planning. Coordinate quality team members and ensure accountability for completing functional work within program deadlines.

• Provides Software Quality leadership for software verification and validation activities, including review and approval of test strategies, test levels (unit, integration, system, and acceptance), automated testing approaches, protocols, execution readiness, defect management, and test results.

• Ensures robust software test method development and qualification, partnering with software engineering, systems engineering, DevOps, and test teams to establish scalable, repeatable, traceable, and compliant testing frameworks and environments.

• Owns and drives software and system risk management activities, including software hazard analysis, software FMEAs, cybersecurity risk assessments, and risk/benefit evaluations, ensuring alignment with system architecture, clinical intent, user workflows, and real-world operating environments.

• Leads Software Quality oversight for software release and deployment readiness, collaborating with development, DevOps, IT, manufacturing systems, supplier quality, and regulatory partners to ensure controlled builds, configuration management, validation status, and commercialization readiness.

• Guides cross functional teams through software phase gate reviews, design reviews, release reviews, and key quality decision points, providing clear, risk-based recommendations and quality leadership.

• Monitors and ensures the integrity of software documentation and records, including software development files, traceability matrices, requirements to test linkage, configuration management, and change control throughout the software lifecycle.

• Drive and analyze software quality metrics for assigned programs, ensuring continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.

• Develop strong expertise in assigned products, including hands-on time in the engineering lab and participation in product training as assigned. Attend live cases 2–3 times per year to enhance workflow and product knowledge.

• Coordinates Software Quality activities as appropriate with external suppliers, test vendors, and consultants, ensuring timely delivery, compliance, cybersecurity posture, and risk mitigation.

• Identifies gaps, risks, and improvement opportunities in software quality processes, SDLC execution, test automation, defect prevention, and post market feedback loops; drives corrective actions and continuous improvement initiatives.

• Serves as a mentor, technical leader, or potential direct manager to earlier career Software Quality engineers or Software QCTMs.

• Other duties may be assigned.

Travel Requirement: up to 10% if based in Newton; up to 30% if based in Mounds View

REQUIRED QUALIFICATIONS

• Bachelor's degree and a minimum of 5 years of relevant experience

• OR Advanced degree with a minimum of 3 years of relevant experience

PREFERRED QUALIFICATIONS

• Ability to effectively read, interpret, and understand existing software code.

• Excellent written and oral communication skills.

• 5+ years of medical device industry experience.

• 5+ years of industry experience in software development.

• Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.

• Experience with cardiac and electrophysiology medical specialties.

• Advanced degree in a relevant field.

• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).

• Strong preference will be given to candidates with existing Medtronic Quality Core Team Member (QCTM) experience.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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): $150,400.00 - $225,600.00

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
- 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)
- 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.

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.