Senior Software Quality Engineer - Reliability & Compliance

Medtronic; Mounds View (MN); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) with employer match

Tuition assistance

Job summary

Medtronic is seeking a software quality-focused professional to support regulatory-compliant development for cardiac electrophysiology software. The role involves collaboration across R&D, regulatory affairs, and clinical teams to ensure robust quality processes and post-market support.

The candidate will engage in design history review, risk analysis, and documentation development, with onsite collaboration and cross-functional training in a regulated medical device environment.

Qualifications

• Bachelor's degree and at least 4 years of relevant experience, or equivalent for advanced degrees.
• Master's degree with 2+ years, or PhD with 0 years experience.
• Experience in medical device software and regulated environments is preferred.

Responsibilities

• Support software quality and reliability for Cardiac Ablation Solutions.
• Collaborate with extended quality team on software releases.
• Review and approve Design History File documents for software and security.
• Develop and review documentation for traceability and compliance.
• Gain product/project expertise with hands-on lab time and training.
• Participate in software risk analysis and defect assessments.
• Track software quality metrics to monitor and improve reliability.
• Provide software quality support for post-market activities and CAPAs.

Skills

Communication

Coding basics

Regulatory knowledge

Education

Bachelor's degree or higher

Master's degree

PhD

Tools

Python

Qt

Docker

Linux

Job description

Medtronic is seeking a software quality-focused professional to support regulatory-compliant development for cardiac electrophysiology software. The role involves collaboration across R&D, regulatory affairs, and clinical teams to ensure robust quality processes and post-market support.

The candidate will engage in design history review, risk analysis, and documentation development, with onsite collaboration and cross-functional training in a regulated medical device environment.