Senior Principal Software Quality Engineer - MedTech Safety

Becton Dickinson; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

Becton Dickinson in Irvine, CA is seeking a Principal Engineer in Software Quality to define and drive robust QA processes across the software lifecycle for medical device products.

You will lead risk management, design and code reviews, and defect handling to ensure compliant, high quality software that improves patient outcomes. A senior, cross-functional role reporting to the quality leadership.

Qualifications

• Bachelor's or Master's degree in a related technical field.
• 10+ years in software quality or software engineering, with at least 5 years in a lead or principal role.
• Strong understanding of SDLC methodologies in regulated contexts.
• In-depth knowledge of FDA 21 CFR Part 820 (QSR), ISO 13485, and IEC 62304.
• Excellent communication and collaboration skills.

Responsibilities

• Develop and maintain software quality assurance strategies and plans.
• Lead design, code, and test reviews to identify quality risks early.
• Manage software risk files and implement mitigation actions.
• Oversee defect management and change control board meetings.
• Collaborate with development, regulatory, and project teams.
• Conduct root cause analysis and verify corrective actions.
• Drive continuous improvement of QA processes and metrics.
• Support audits and stay current with medical device standards.

Skills

Regulatory compliance

SDLC

Quality Assurance

Risk management

Leadership

Education

Bachelor's or Master's degree in Computer Science/Engineering/Biomedical Engineering

Tools

Polarion ALM

Job description

Becton Dickinson in Irvine, CA is seeking a Principal Engineer in Software Quality to define and drive robust QA processes across the software lifecycle for medical device products.

You will lead risk management, design and code reviews, and defect handling to ensure compliant, high quality software that improves patient outcomes. A senior, cross-functional role reporting to the quality leadership.