Medical Device Software Quality Engineer (IEC 62304)

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

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.