Principal Engineer, Software Quality

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

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As the Principal Engineer in Software Quality, you will play a critical role in ensuring the quality and reliability of our medical device software. You will be responsible for defining, implementing, and executing robust quality assurance processes throughout the entire software development lifecycle, contributing to the delivery of safe and effective products that positively impact patient care.

Job Responsibilities

• Develop, implement, and maintain comprehensive software quality assurance strategies, plans, and procedures in accordance with industry best practices and regulatory requirements (e.g., FDA, ISO 13485, IEC 62304).
• Lead review from Quality perspective for design, development, and execution of comprehensive test plans, test cases, and automation scripts for complex software systems, including embedded, application, and cloud-based solutions.
• Extensive knowledge of software risks and develop risk management files for software and system level risk.
• Lead defect management and CCB meetings to review and disposition project defects
• Lead and participate in design reviews, code reviews, and other technical assessments to identify potential quality issues early in the development process.
• Understanding of test plans, test cases, and test scripts for various levels of testing, including unit, integration, system, and regression testing.
• Perform risk analysis and develop mitigation strategies for software defects and quality-related issues.
• Perform root cause analysis for software defects and collaborate with development teams to implement effective corrective and preventive actions.
• Drive continuous improvement initiatives in software quality processes, tools, and metrics, leveraging industry standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820).
• Understanding of complaint handling process, metrics and product risk assessment
• Collaborate closely with software development, project management, and regulatory affairs teams to ensure seamless integration of quality activities throughout the product lifecycle.
• Investigate, analyze, and document software defects, working with development teams to ensure timely resolution and verification.
• Participate in external and internal audits, providing documentation and expertise related to software quality.
• Stay current with emerging technologies, industry trends, and regulatory changes in medical device software quality.
• Provide technical leadership and mentorship to junior quality engineers, fostering a culture of quality and continuous learning.
• Experience with Polarion ALM system is a plus
• Comfortable presenting to upper management

Job Qualifications

• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.
• Minimum of 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 software development lifecycle (SDLC) methodologies (e.g., Agile, Waterfall) and their application in a regulated context.
• In-depth knowledge of relevant medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, and IEC 62304.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00 USD Annual