Principal Software Quality Engineer – Medical Devices

Regulatory Toolkit; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD, a leading medical technology company, seeks a Principal Engineer in Software Quality to define and execute robust QA processes across the software development lifecycle. You will contribute to patient safety by ensuring high-quality software for embedded, application, and cloud-based systems.

You will lead design and code reviews, manage risk, drive QA automation, and collaborate across software, regulatory affairs, and project management teams in a fast-paced environment.

Qualifications

• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• 10+ years of experience in software quality assurance or software engineering, with at least 5 years in a lead/principal role.
• Strong understanding of SDLC methodologies (Agile, Waterfall) and their application in regulated contexts.
• In-depth knowledge of medical device regulations and standards (FDA 21 CFR Part 820, ISO 13485, IEC 62304).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication and interpersonal skills; able to collaborate cross-functionally.
• Ability to work independently and as part of a fast-paced, dynamic team.

Responsibilities

• Develop, implement, and maintain software quality assurance strategies, plans, and procedures per regulatory requirements.
• Lead QA reviews for design, development, and test plans, including automation scripts for embedded, application, and cloud-based solutions.
• Maintain software risk management files; conduct risk analyses and mitigations.
• Lead defect management and Change Control Board meetings, review and disposition defects.
• Participate in design and code reviews to identify quality issues early in development.
• Verify test plans, test cases, and scripts across unit, integration, system, and regression testing.
• Perform root cause analysis for defects and drive corrective and preventive actions.
• Drive continuous improvement in software quality processes, tools, and metrics per ISO/IEC/FDA standards.
• Collaborate with software development, regulatory affairs, and project management for lifecycle quality integration.
• Support audits with documentation and expertise on software quality.

Skills

Quality Assurance

SDLC knowledge

Regulatory experience

Communication skills

Independent work

Team collaboration

Education

Bachelor's or Master's degree in CS/SE/BME

Tools

Polarion ALM

Job description

BD, a leading medical technology company, seeks a Principal Engineer in Software Quality to define and execute robust QA processes across the software development lifecycle. You will contribute to patient safety by ensuring high-quality software for embedded, application, and cloud-based systems.

You will lead design and code reviews, manage risk, drive QA automation, and collaborate across software, regulatory affairs, and project management teams in a fast-paced environment.