Software Quality Engineer I - Reliability & Compliance

Regulatory Jobs; Mounds View (MN); On-site; USD 65,000 - 97,000; Full time

Job summary

Medtronic in Minnesota is seeking a Software Quality Engineer to drive regulatory-compliant software quality for cardiac electrophysiology systems. You will partner with R&D, regulatory, and clinical teams to ensure design, development, and post-market activities meet quality and safety standards.

The role emphasizes hands-on lab work, access to training, and collaboration across functions to achieve reliable, secure software products in a fast-paced healthcare environment.

Qualifications

• Bachelor's degree and a minimum of 0 years of relevant experience.
• Must be able to write new software code, and read existing code to collaborate with software engineers.
• Experience in a medical device or regulated industry is a plus.
• Excellent written and verbal communication skills.
• Experience performing formal risk analysis.

Responsibilities

• Support software quality efforts for Cardiac Ablation Solutions products, ensuring regulatory compliance with FDA CFR, MDR, IEC 62304, and ISO 13485.
• Collaborate with the extended quality team to complete assigned work within program deadlines.
• Participate in software risk analysis activities to ensure comprehensive risk file coverage.
• Provide software quality support for post-market activities including defect assessments and CAPAs.
• Review and approve Design History File documents for software and security to meet reliability and QMS standards.
• Develop and review documentation for traceability, testability, and compliance.
• Develop expertise in assigned products and participate in product training.
• Track software quality metrics to monitor and improve reliability.
• Recommend design or test methods to improve reliability and security.
• Contribute to quality engineering program strategies to meet regulatory objectives.
• Review strategies for product security testing.
• Attend live EP cases annually to enhance workflow and knowledge and participate in live case学习 opportunities.
• Collaborate with R&D, medical safety, regulatory affairs, and clinical teams to align requirements.

Skills

Regulatory compliance

Quality engineering

Software quality

Cross-functional collaboration

Python

Education

Bachelor's degree

Tools

Python

Qt

Docker

Linux

Job description

Medtronic in Minnesota is seeking a Software Quality Engineer to drive regulatory-compliant software quality for cardiac electrophysiology systems. You will partner with R&D, regulatory, and clinical teams to ensure design, development, and post-market activities meet quality and safety standards.

The role emphasizes hands-on lab work, access to training, and collaboration across functions to achieve reliable, secure software products in a fast-paced healthcare environment.