Senior Principal Software Quality Engineer (MedTech)

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

Job summary

Becton, Dickinson and Company in Irvine, CA is seeking a Senior Software Quality Engineer to develop and govern comprehensive QA strategies for embedded, application, and cloud-based software in regulated medical devices.

You will lead QA reviews, risk management, and test plan creation, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, and industry best practices while collaborating with software, regulatory, and project teams to deliver safe, high-quality products.

Qualifications

• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.
• 10+ years in software quality assurance or software engineering, with at least 5 years in a lead or principal role.
• SDLC experience (Agile, Waterfall) in a regulated context.
• FDA 21 CFR Part 820 (QSR), ISO 13485, IEC 62304 knowledge.
• Analytical, problem-solving, and critical thinking skills.
• Strong communication and interpersonal skills; cross-functional collaboration.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Develop, implement, and maintain QA strategies, plans, and procedures per industry and regulatory requirements.
• Lead review of design, development, and test plans, including automation scripts for complex software systems.
• Lead defect management and risk analysis; drive CAPA actions.
• Participate in design and code reviews to identify quality issues early.
• Collaborate with software, regulatory affairs, and project teams across the lifecycle.

Skills

Analytical thinking

Problem solving

Communication

Team collaboration

Independence

Education

Bachelor's or Master's degree in Computer Science

Tools

Polarion ALM

Job description

Becton, Dickinson and Company in Irvine, CA is seeking a Senior Software Quality Engineer to develop and govern comprehensive QA strategies for embedded, application, and cloud-based software in regulated medical devices.

You will lead QA reviews, risk management, and test plan creation, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, and industry best practices while collaborating with software, regulatory, and project teams to deliver safe, high-quality products.