Software Quality Engineer

Sira Consulting, an Inc 5000 company; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sira Consulting in Irvine, CA seeks a Software Quality Engineer to ensure neurovascular medical device software quality and regulatory compliance. You will perform verification and validation, develop test protocols, and maintain traceability across design documentation.

The role requires experience with medical device software quality, IEC 62304, and ISO 13485, with responsibilities including audits support and defect analysis.

Qualifications

• Bachelor's or Master's degree in Software, Biomedical, Electrical/Electronics engineering with medical device software quality experience.
• Experience performing V&V for medical device software and risk management.
• Familiarity with regulatory submissions and quality system requirements.

Responsibilities

• Perform software verification & validation (V&V) for neurovascular devices.
• Develop and execute test protocols and maintain traceability.
• Ensure compliance with IEC 62304 and ISO 13485.
• Manage defect tracking and root cause analysis.
• Support audits and regulatory submissions.
• Maintain design documentation and traceability.

Skills

Software Quality Engineering

Medical Device Regulations (FDA, EU MD

Education

Bachelor's/Master's in Engineering (Software, Biomedical, Electronics)

Job description

Responsible for ensuring software quality and compliance of neurovascular medical devices through rigorous verification, validation, and regulatory adherence.

Key Responsibilities

• Perform software verification & validation (V&V)
• Develop and execute test protocols
• Ensure compliance with IEC 62304, ISO 13485
• Manage defect tracking and root cause analysis
• Support audits and regulatory submissions
• Maintain traceability and design documentation

Required Skills

• Software Quality Engineering
• Medical Device Regulations (FDA, EU MDR)

Qualifications

Bachelor's/Master's in Engineering (Software, Biomedical, Electronics) with experience in medical device software quality.