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 maker of 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.