Design Quality Engineer

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Provide technical leadership and guidance to Quality Engineers, Quality Technicians, and Inspectors.
• Lead and support quality engineering projects that enhance quality systems, procedures, and compliance processes.
• Develop test protocols and final reports to support regulatory submissions, including FDA 510(k), PMA, CE Mark, and international product registrations.
• Support early-stage product innovation activities by contributing quality expertise during pre-concept and front-end development of new technologies.
• Develop and maintain Risk Management Files, coordinating input across cross-functional design teams.
• Participate in the creation and execution of Design Verification and Design Validation protocols, analyze results, and determine overall design acceptability.
• Contribute to project Trace Matrices, Product Performance Specifications, Product Development Plans, and other design control documentation in accordance with the BD UCC product development process.
• Coordinate and document external laboratory testing activities, including cleaning and reprocessing validations.
• Develop and improve inspection and test methods aligned with product specifications.
• Support shelf-life and stability studies by developing test protocols and final reports used to establish expiration dating.
• Perform test method validations to ensure analytical and physical testing methods are accurate, precise, reliable, and reproducible.
• Create and maintain inspection plans for components, subassemblies, and finished products.
• Support the development of manufacturing control plans for both internal and outsourced manufacturing processes.
• Lead or support risk management activities, including AFMEA, DFMEA, and PFMEA development.
• Conduct and support process development studies to evaluate new manufacturing processes and equipment.
• Design, qualify, and validate inspection methods, testing equipment, and measurement systems.
• Provide quality engineering support to outsourced laboratories and manufacturing partners, ensuring compliance with 21 CFR 820, 210, 211, cGMP, and ISO 13485 requirements.
• Lead supplier qualification activities, including component qualification, mold validation, and Design of Experiments (DOE).
• Support process transfers and scale-up activities into production environments.
• Review and disposition nonconforming materials and products.
• Analyze quality data and generate reports to identify trends, monitor process performance, and assess the effectiveness of process improvements and CAPAs.
• Develop and implement corrective and preventive action plans to address nonconformances and drive continuous improvement.
• Apply statistical methods, including DOE and data analysis techniques, to optimize products and processes and identify root causes of variation.
• Provide technical expertise to resolve quality issues across product development, pilot production, manufacturing operations, and supplier networks.
• Support departmental and organizational quality objectives through collaboration and continuous improvement initiatives.
• Mentor and develop junior team members, fostering technical growth and quality excellence.
• Serve as the Business Unit Subject Matter Expert (SME) for Reliability Engineering.
• Perform additional quality control and quality engineering…