Software Quality Engineer II (Reliability/ Compliance)

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 Quality Engineer II 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 drive quality for 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.

*This position is not eligible for immigration sponsorship. Applicants must be authorized to work 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 as FDA CFR, MDR, IEC 62304, and ISO 13485.

Serve as member of 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 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.

Develop expertise in 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 achieve appropriate levels of 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 reliability objectives for 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. Regularly participate in virtual live case 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:

Required Qualifications

Bachelor's degree and a minimum of 2 years of relevant experience

• •OR Master’s degree with 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 of cybersecurity and the 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 in quality systems or regulatory 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 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.

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 AskHR@medtronic.com .

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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, reso