Software Quality Engineer

I3 INFOTEK INC; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

I3 INFOTEK INC in Irvine, CA is seeking a Software Quality Engineer for medical device software. You will drive V&V activities, create and execute test protocols, and ensure adherence to IEC 62304 and ISO 13485. The role includes defect tracking, root cause analysis, and supporting regulatory submissions.

Ideal candidates hold a Bachelor's or Master’s in Engineering with experience in medical device software quality and familiarity with FDA/EU MDR requirements.

Qualifications

• Bachelor’s or Master’s degree in Engineering with experience in medical device software quality (software quality assurance, risk management).
• Familiarity with FDA/EU MDR requirements and IEC 62304/ISO 13485 standards.
• Experience performing V&V, test protocols, and defect management in regulated environments.

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.

Skills

Software Quality Engineering

Medical Device Regulations

Test Automation

Programming

Education

Bachelor’s/Master’s in Engineering

Job description

• 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)
• Test Automation & Manual Testing
• Programming: Python/C/C++

Qualifications

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