Job Description Summary

This position is part of the Central Quality team and reports to the Sr Director of Quality Engineering. The role is responsible for software quality across STS and Incada and serves as a member of the STS leadership team. The Director of Software Quality will lead strategic quality initiatives, manage software quality engineering teams, and ensure compliance with regulatory standards and internal quality systems.

Job Description

We are the makers of possible

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a makerof possible with us.

Responsibilities

• Leading the development, establishment and maintenance of Quality Assurance and Engineering programs in the STS team.

• Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and development.

• Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security. 

• Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.

• Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).

• Align software validation practices across BD.

• Manage quality metrics and present them in management reviews.

• Provide Design and Development leadership during FDA and Notified body site inspections.

• Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors

• Maintain effective design-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work.

• Actively identify improvements to the processes within the QMS to enhance both compliance and quality.

• Assess resource needs to align the required level of quality support provided

Education and Experience

• Bachelor's degree in engineering, computer science, or life sciences.

• 15+ years of experience in software design and development within Medical Device regulated industry.

• Experience managing software quality engineering teams and leading complex software projects.

• ASQ certifications (CQA, CQE, CSQE, CMQ) are a plus.

Knowledge and Skills:

• Expert knowledge of software development lifecycle and test methodologies.

• Strong understanding of design controls, risk management, and product security.

• Familiarity with regulatory standards including ISO 13485, IEC 62304, and 21 CFR.

• Excellent leadership, project management, and cross-functional collaboration skills.

• Ability to influence without direct authority and manage organizational change.

• Excellent communication skills (up, down, and outward)

• Experience in Agile/SAFe methodologies is preferred

• Experience in Cloud/SaaS software product development is preferred

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

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

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

USA NJ - Franklin Lakes

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$179,200.00 - $322,500.00 USD Annual