Sr. Software Quality Engineer

Responsibilities

• Support software quality and reliability efforts for Cardiac Ablation Solutions, ensuring compliance with FDA CFR, MDR, IEC 62304, and ISO 13485.
• Review and approve Design History File (DHF) documents, including requirements, design, test protocols, and verification/validation reports.
• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
• Participate in software risk analysis, defect assessments, and the tracking of software quality metrics.
• Provide quality support for post-market activities, including issue assessments, health risk assessments, and CAPAs.
• Collaborate with cross-functional teams including R&D, regulatory affairs, and clinical teams to ensure alignment on compliance requirements.

Requirements

• Bachelor's degree and 4+ years of relevant experience, OR Master's degree and 2+ years of relevant experience, OR PhD with 0 years of relevant experience.
• Knowledge of regulatory standards including FDA CFR, MDR, IEC 62304, and ISO 13485.
• Ability to read, interpret, and understand existing software code.

Preferred Qualifications

• 2+ years of experience in the medical device industry or other regulated industries (e.g., defense or aerospace).
• Experience creating risk analysis documentation such as FMEAs and FTAs.
• Experience working with products built on Python, Qt, Docker, and Linux.
• Strong knowledge of cybersecurity and the software lifecycle in regulated environments.
• Experience with cardiac and electrophysiology medical specialties.
• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ).

Benefits

• Competitive salary and Medtronic Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan.

About the Company

Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. We engineer extraordinary solutions to solve the world's most challenging health problems through innovation, research, and a mission-driven culture.