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

The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Design Control activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

Responsibilities:

• Serve as the primary Quality representative for New Product Development (NPD) and sustaining programs, partnering closely with Core Teams from concept through commercialization.
• Own and manage all quality aspects of design controls, including quality planning, verification and validation (V&V), risk management, and regulatory/compliance support.
• Act as a design controls subject matter expert, providing guidance and clarity to cross‑functional teams on quality system requirements throughout the product lifecycle.
• Collaborate closely with Program Managers to ensure design deliverables are completed on time and ready for limited commercial or general release.
• Partner with fellow Quality Engineers to ensure robust verification of design requirements and specifications.
• Monitor and ensure ongoing compliance with company policies, procedures, and applicable international standards.
• Review and approve Change Orders (COs) and Electronic Release Authorizations (ERAs) for new releases and design enhancements.
• Identify opportunities for quality and process improvement, initiates and follows through on plans of action necessary for implementation.
• Actively contribute to product requirements development, system hazard analyses, and formal design reviews.
• Ensure Design History Files (DHFs) and product technical files are complete, accurate, and audit‑ready.
• Drive continuous improvement initiatives by facilitating and leading cross‑functional collaboration.
• Demonstrate strong knowledge of quality engineering principles, policies, and best practices across the product development lifecycle.
• Apply a solid understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to execute responsibilities with minimal supervision.
• Leverage comprehensive knowledge of system‑level product development, including hardware, software, verification/validation, risk management, and integration testing.
• Analyze quality and development data, generate reports, interpret trends, and make risk‑based recommendations to support sound business and technical decisions.
• Use expertise to streamline and enhance design assurance practices while avoiding unnecessary burden.
• Represent the Quality organization on cross‑functional Core Teams.
• Review complex system solutions and verification results, clearly communicating findings to engineering teams to enable timely issue resolution.
• Participate actively in design reviews and milestone reviews.
• Operate effectively in both well‑defined and ambiguous environments, applying sound judgment and risk‑based thinking.

Qualifications:

• Bachelor’s degree in Engineering or a related technical field.

• 8 years of experience supporting R&D development, with strong emphasis on design controls and regulated product development.

• Experience supporting complex system integrations and cross‑functional design teams is preferred

Knowledge and Skills:

• Thorough understanding of risk management and design for manufacturability, serviceability, and reliability/

• Attentiveness to details with strong organizational skills

• Ability to work proactively and independently

• Ability to multi-task and efficient in time management

• Excellent verbal communication and interpersonal skills with the ability to work in a team environment

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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

.

Primary Work Location

USA NC - Durham - Roche Drive

Additional Locations

Work Shift