Software Quality Engineer II — Medical Devices

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

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.