Principal Software Quality Assurance Engineer

Job Summary

Leading software assurance activities throughout the medical device software life cycle, the full-time remote Principal Software Quality Assurance Engineer will ensure compliance with regulatory requirements, conduct audits, and support quality processes while collaborating with cross-functional teams.

Key responsibilities

• Oversee software quality assurance plans, safety classifications, and readiness assessments throughout the software life cycle
• Participate actively in the software team, reviewing and approving requirements, designs, and test procedures while providing insights on project status and quality metrics
• Ensure compliance with regulatory standards, perform gap assessments, and escalate major issues affecting patient safety or software integrity

Required qualifications

• Master's degree in Computer Science, Software Engineering, or related field with five years of experience in software quality assurance, or a Bachelor's degree with seven years of experience
• Experience in software quality assurance within the medical device, aerospace, or automotive industries
• Knowledge of medical device regulations and standards such as ISO 13485 and IEC 62304
• Experience developing and testing software systems, including embedded software
• Familiarity with software engineering best practices and technologies such as IoT and Bluetooth