Sr. Software Quality Engineer (Reliability/Compliance)

About this role

We anticipate the application window for this opening will close on - 8 Sep 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   Senior   Software Quality Engineer   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.  

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 Affera software releases used for mapping and navigation in electrophysiology procedures .    Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.  

• 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.  

• Participate in software risk analysis and defect assessments 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.  

• Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.   

• 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 reliability 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, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.  

• Travel Requirement:  

Required Qualifications  

• Bachelor's degree and   a minimum of   4   years of relevant experience  

• OR   Master’s   degree with   a minimum of   2   years of relevant experience  

• OR PhD with 0 years relevant experience    

Preferred Qualifications  

• At least 1 year of experience supporting product development.  

• Though this is not a coding role, the a bility to perform simple coding tasks and effectively read, interpret, and understand existing software cod e   to   collaborate and execute necessary work with software engineers is needed  

• Excellent written and oral communication skills.  

• 2+ years of medical device or other regulated industry (such as defense or aerospace) experience.  

• 2+ years of 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, Qt, Docker, and Linux.  

• 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).  

        #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. F

Similar jobs

• Sr Quality/Reliability Engineer — Milwaukee Tool · Brookfield, WI
• Sr. Quality Assurance Engineer — Moog · Phoenix, AZ
• Sr. Quality Engineer — Medline · Chicago, Illinois
• Sr. Quality Engineer — Oshkosh Corporation · Hagerstown, Maryland, United States
• Sr. Quality Engineer — Trendmicro · Austin
• Sr. Quality Engineer — Creation · Dallas, TX
• Sr. Reliability Engineer — Every day Chemours · Parkersburg, WV | Belle, WV | Louisville, KY
• Sr. Reliability Engineer — Milwaukee Tool · Milwaukee, WI