Sr. Design Quality Engineer

Job Description Summary

We have an immediate opening for a highly motivated, results-focused professional to join our team as a Senior Staff Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance with company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics.

This role is in the Quality organization and has no direct responsibility for software testing (V&V).

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. 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.

We believe that the human element, across our global teams, allows us to continually evolve. Join us to learn, grow, and become your best self. Become a maker of possible with us.

The Senior Staff Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. It also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.).

BD’s Pharmacy Automation Central Fill solutions are designed to transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation. These centralized facilities serve networks of retail pharmacies, hospital systems, care facilities, and mail-order services, enabling efficient medication distribution from a single location.

• Serve as the quality cornerstone for multi-functional design teams, championing excellence in both new product development and sustaining engineering efforts
• Orchestrate comprehensive quality strategies throughout the design control lifecycle—from initial planning through verification and validation to risk management and regulatory compliance
• Provide expert guidance on quality system implementation, with specialized focus on design controls
• Conduct thorough reviews of design documentation, ensuring meticulous compliance with QMS requirements and documentation protocols prior to final approval
• Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets
• Ensure robust verification and validation protocols that definitively confirm design specifications and requirements
• Maintain comprehensive traceability matrices across all design elements, showing clear linkage from requirements to implementation
• Provide vital quality insights during product requirement development, system hazard analysis, and critical design reviews
• Build collaborative partnerships across functions to drive consensus and resolve challenges efficiently
• Lead root cause investigations and structured problem-solving initiatives for development and manufacturing challenges
• Curate impeccable technical files and Design History Files that withstand regulatory scrutiny
• Orchestrate continuous improvement initiatives through multi-functional collaboration and innovation
• Demonstrate mastery of quality engineering principles, methodologies, and industry standards
• Apply understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304
• Leverage knowledge of software quality assurance throughout the development lifecycle
• Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies
• Utilize advanced engineering tools including…