Software Quality Engineer I (Reliability/Compliance) Job at Medtronic, Newton, MA

  • Medtronic
  • Newton, MA

Job Description

Software Quality Engineer supporting cardiac electrophysiology systems at a global medical device company. The role involves ensuring software compliance with regulatory standards, participating in risk analysis, and collaborating with cross-functional engineering teams to maintain product reliability and quality throughout the software lifecycle.

Responsibilities

  • Support software quality and regulatory compliance for Affera cardiac ablation products
  • Participate in software risk analysis and Design History File documentation reviews
  • Conduct post-market activities including defect assessments and CAPA support
  • Track and monitor software quality metrics to drive continuous improvement
  • Collaborate with R&D, regulatory, medical safety, and clinical teams on quality alignment

Requirements

  • Bachelor's degree in relevant field
  • Ability to write and interpret software code effectively
  • Medical device or regulated industry experience preferred
  • Knowledge of FDA CFR, MDR, IEC 62304, and ISO 13485 standards
  • Experience with formal risk analysis activities
  • Familiarity with Python, Qt, Docker, and Linux preferred

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