Software Quality Engineer I
Medtronic
Mounds View, Minnesota, United States of America
Full-Time
$64,800
RemoteExecutive
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 95,000 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.
In this dynamic role,you’llwork 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 outcomes,you'llhave 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 as FDA CFR, MDR, IEC 62304, and ISO 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 for post-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 security.Propose 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 knowledge. Regularlyparticipatein 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
Bachelor's degree anda minimum of0years of relevant experience
Preferred Qualifications
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.
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 of cybersecurity and the 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 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.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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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.
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, andSimple 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), andCapital 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
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.