Software Quality Engineer I

We anticipate the application window for this opening will close on - 8 Nov 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

A Day in the Life

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were 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.

*This position is not eligible for immigration sponsorship. Applicants mustbe authorized towork in the country of employment without sponsorship*

In this dynamic roleyoullwork alongside a team of engineers and cross-functional partners to drive quality for design development and maintenance of software for Affera cardiac electrophysiology systems. By blending technicalexpertisewith a passion for quality compliance and improving patient outcomesyoullhave the opportunity toimpactglobal healthcare as the usage of Affera grows rapidly worldwide.

Primary Responsibilities

• Support software quality efforts for Cardiac Ablation Solutions products ensuring compliance with regulatory standards such asFDA CFR MDR IEC 62304 andISO 13485.

• Serve asmemberof the extended quality team for Affera software releases used for electrophysiology procedures. Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.

• Participate in software risk analysis activities to ensure comprehensive risk file coverage for software.

• Provide software quality support forpost-market activities and analysis as assigned including work supporting defect assessments issue assessments health risk assessments and CAPAs.

• Review and approve various Design History File documents related to software and security including requirements design development integration test protocols test reports verification validation and tooling. Ensure all documentation meets reliability standards and follows QMS processes.

• Develop and review documentation for traceability testability and compliance according to standard operating procedures.

• Developexpertisein assigned products and projects including hands-on time in the engineering lab and participation in product training as assigned.

• Contribute to tracking software quality metrics for assigned programs supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.

• Recommend design or test methods to achieveappropriate levelsof product reliability and changes to design or testing as necessary to improve software and/or process reliability.

• Contribute to quality engineering program strategies to achieve Medtronic customer and regulatory reliabilityobjectivesfor assigned programs.

• Review and support strategies for product security testing as assigned.

• As available attend a live EP case at least once per year to enhance workflow and product virtuallivecase learning opportunities.

• Collaborate with cross-functional teams including R&D medical safety regulatory affairs and clinical teams to ensure alignment on quality and compliance requirements.
  

*Travel Requirement: <10%

Required Qualifications

• Bachelors degree anda minimum of0years of relevant experience
• Though this is not a coding role the candidate must have proven ability to write new software code and quickly and effectively read interpret and understand existing software code to collaborate and execute necessary work with software engineers.
  

Preferred Qualifications

• Excellent written and oral communication skills.

• Medical device or other regulated industry (such as defense or aerospace) experience and/or industry experience working with a software development team.

• Experience performing formal risk analysis.

• Experience using or working with Python Qt Docker and Linux.

• Knowledge ofcybersecurityandthe software lifecycle within regulated environments including design development and post-market support.

• Experience with cardiac/electrophysiology medical specialties.

• Advanced degree in a relevant field.

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

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 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.

If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .

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):$64800.00 - $97200.00

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 ratecomplies withfederal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits informationpertainssolely 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:

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 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.

Required Experience:

IC