Software Quality Engineer II (Reliability/Compliance)

Regulatory Jobs; Mounds View (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Medtronic is seeking a Software Quality Engineer II in Minnesota to drive quality for design, development, and maintenance of software for Affera cardiac electrophysiology systems. You will work with an engineering team and cross-functional partners to ensure regulatory compliance and product reliability.

The role emphasizes hands-on quality activities, documentation, risk analysis, and collaboration across R&D, regulatory, and clinical teams.

Qualifications

• Bachelor’s degree and minimum of 2 years relevant experience.
• Master’s degree preferred with relevant experience.
• Ability to write new software code and read/understand existing code.

Responsibilities

• Support software quality and reliability for Cardiac Ablation Solutions products.
• Collaborate with cross-functional teams to ensure quality and regulatory compliance.
• Participate in software risk analysis to ensure risk file coverage.
• Provide software quality support for post-market activities and CAPAs.
• Review and approve Design History File documents for software and security.
• Develop documentation for traceability, testability, and compliance.
• Travel <15%.

Skills

Code writing ability

Written and verbal communication

Education

Bachelor's degree in a relevant field

Master’s degree in a relevant field

Tools

Python

Linux

Docker

Windows

AWS

REST APIs

React

Flutter/Dart

Job description

We anticipate the application window for this opening will close on - 26 Oct 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 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.

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.

Join Medtronic as a Software QualityEngineer IIand be at the forefront of transforming lives through advanced medical technology! 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.

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

Primary Responsibilities

• Support software quality and reliability 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 therapy software, operating systems, and service/manufacturing tooling software releases across the Affera portfolio. 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 meet 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: <15%

Required Qualifications

• Bachelor's degree anda minimum of2years of relevant experience

• ORMaster’sdegreewith a minimum of 0 years 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 creating risk analysis documentation such as FMEAs and FTAs.

• Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart.

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

• Advanced degree in a relevant field.

• Experience with cardiac/electrophysiology medical specialties.

• Certification inquality systemsorregulatory affairs(e.g., Six Sigma, ASQ, or similar).

#LI-MDT

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