Becton, Dickinson and Company

Principal Engineer, Software Quality

Becton, Dickinson and Company • $129K — $207K *
Irvine, CA 92620In-Person
Hospitals & Medical Centers
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or Master's in Computer Science, Software Engineering, Biomedical Engineering, or related field.
  • 10+ years of experience in software quality assurance or engineering, with 5+ years in a lead role.
  • Strong grasp of software development lifecycle methodologies (Agile, Waterfall) in regulated environments.
  • Deep knowledge of medical device regulations like FDA 21 CFR Part 820, ISO 13485, IEC 62304.
  • Sharp analytical, problem-solving, and critical thinking ability.
  • Excellent verbal and written communication skills for cross-team collaboration.
  • Capacity to work both independently and collaboratively in a fast-paced setting.

Responsibilities

  • Develop and maintain software quality assurance strategies aligned with industry regulations.
  • Lead quality reviews for design, development, and execution of test plans and automation scripts.
  • Manage software and system-level risks through effective risk management documentation.
  • Oversee defect management and conduct meetings to address project defect resolutions.
  • Facilitate design, code reviews, and technical assessments to catch quality issues early.
  • Analyze software defects, collaborating with development teams for prompt solutions.
  • Drive initiatives for continuous improvement in quality processes and metrics.

Benefits

  • Technical leadership opportunities and mentorship roles for junior engineers.
  • Engagement in a highly regulated field impacting patient safety and care.
  • Participation in cutting-edge projects involving medical device software.
  • Opportunities to collaborate with diverse teams including development and regulatory affairs.
  • Potential for continuous professional development within a dynamic, evolving sector.
Full Job Description
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.


Primary Work Location
USA CA - Irvine Laguna Canyon

Salary Range Information
$129,600.00 - $207,400.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Becton, Dickinson and Company.

Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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