Principal Software Quality Engineer – Medical Devices

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

Job summary

Becton, Dickinson, and Company is seeking a Principal Engineer in Software Quality to ensure the quality and reliability of medical device software across the lifecycle. You will define and implement QA processes to deliver safe, effective products.

You will lead design/code reviews, risk analyses, and continuous improvement of QA tools and metrics, working with cross-functional teams in a regulated environment. This is a high-impact, leadership role in Irvine, CA.

Qualifications

• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.
• 10+ years of experience in software quality assurance or software engineering, with at least 5 years in a lead or principal role.
• Strong understanding of SDLC methodologies (e.g., Agile, Waterfall) in a regulated context.
• In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team in a fast-paced environment.

Responsibilities

• Develop, implement, and maintain software quality assurance strategies and procedures in accordance with regulatory requirements.
• Lead review from Quality perspective for design, development, and test plans, with automation scripts for complex software systems.
• Perform risk analysis and develop mitigation strategies for software defects and quality issues.
• Lead defect management and change control board meetings; review project defects.
• Lead and participate in design reviews, code reviews, and other assessments to identify quality issues early.

Skills

Analytical skills

Problem solving

Communication

Teamwork

Leadership

Presentation

Education

Bachelor's or Master's degree in CS/Software Eng/ Biomedical Eng

Tools

Polarion ALM

Job description

Becton, Dickinson, and Company is seeking a Principal Engineer in Software Quality to ensure the quality and reliability of medical device software across the lifecycle. You will define and implement QA processes to deliver safe, effective products.

You will lead design/code reviews, risk analyses, and continuous improvement of QA tools and metrics, working with cross-functional teams in a regulated environment. This is a high-impact, leadership role in Irvine, CA.