Senior Software Quality Engineer – Cardiac MedTech (Onsite)

Medtronic plc; Mounds View, Northern (MN, KY); Hybrid; USD 103,000 - 155,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) Plan

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Short-term incentive (MIP)

Paid time off

Paid holidays

Job summary

Medtronic is seeking a Senior Software Quality Engineer to lead quality and regulatory compliance for software across Affera systems. You’ll collaborate with R&D, regulatory, and clinical teams to ensure design, development, and post-market support meet rigorous standards.

You’ll engage in risk analyses, file reviews, traceability, and contribute to reliability programs, while supporting cross-functional teams in a dynamic, onsite environment.

Qualifications

• Bachelor’s degree with 4+ years relevant experience OR Master’s with 2+ years OR PhD with 0 years

Responsibilities

• Support software quality and reliability for Cardiac Ablation Solutions products, ensuring regulatory standards are met.
• Act as member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures.
• Collaborate with quality team members to meet program deadlines.
• Review and approve Design History File documents for software and security.
• Ensure documentation meets reliability standards and follows QMS processes.
• Develop and review traceability, testability, and compliance documentation.
• Participate in software risk analysis and defect assessments.
• Track software quality metrics and support continuous improvement of quality outcomes.
• Provide software quality support for post-market activities and CAPAs.

Skills

Quality assurance

Regulatory compliance

Cross-functional collaboration

Documentation

Risk analysis (FMEAs/FTAs)

Communications

Cybersecurity awareness

On-site collaboration

Education

Bachelor's degree in relevant field

Master’s degree

PhD

Tools

Python

Qt

Docker

Linux

Job description

Medtronic is seeking a Senior Software Quality Engineer to lead quality and regulatory compliance for software across Affera systems. You’ll collaborate with R&D, regulatory, and clinical teams to ensure design, development, and post-market support meet rigorous standards.

You’ll engage in risk analyses, file reviews, traceability, and contribute to reliability programs, while supporting cross-functional teams in a dynamic, onsite environment.