Design Quality Engineer

Job Description Summary

Staff Design Quality Engineer to support product and process development within the Infusion Platform for New Product Development.

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 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, 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.

The Staff Design Quality Engineer will play a crucial role in ensuring the quality and regulatory compliance of Care Fusion 303, Inc.'s medical devices throughout their entire product lifecycle, from design and development through to market release. This position will involve active participation in design control activities, risk management, and fostering a culture of quality within the engineering teams.

• Actively participate in product design and development activities, providing quality engineering support and guidance.
• Review and approve design inputs, design outputs, design verification, and design validation plans and reports.
• Ensure compliance with design control procedures, medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485), and company policies.
• Contribute to the development and maintenance of Design History Files (DHFs).

• Lead and facilitate risk management activities, including the development and maintenance of risk management plans, hazard analyses, and FMEAs (Failure Mode and Effects Analyses).
• Ensure appropriate risk mitigation strategies are implemented and verified.

• Support post-market surveillance activities by analyzing complaint data and identifying potential quality issues.
• Participate in root cause analysis and corrective and preventive action (CAPA) investigations related to design quality.
• Contribute to the effectiveness verification of CAPA actions.

• Support internal and external audits (e.g., FDA, ISO) by providing documentation and technical expertise related to design quality.
• Ensure ongoing compliance with all applicable quality system regulations and standards.

• Provide guidance and training to engineering teams on design control, risk management, and quality system requirements.
• Act as a mentor to junior quality engineers.

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) required. Master's degree preferred.

• 5+ years of experience in Design Quality Engineering within the medical device industry.
• Demonstrated experience with medical device design controls (21 CFR Part 820.30) and risk management (ISO 14971).
• Strong understanding of ISO 13485 quality management system requirements.
• Experience with Design Verification and Validation activities including software, system, and human factors testing.
• Experience in requirements decomposition, traceability, and test strategy development.
• Understanding of change impact analysis and regression test scoping methods.

• Excellent analytical and problem-solving skills.
• Strong communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proficiency in statistical analysis and quality tools.
• Ability to interpret and apply complex regulatory requirements.
• ASQ certifications (e.g., CQE, CRE) preferred.
• Proficiency in relevant software tools (e.g., Team Center, Polarion, Azure Dev Ops , PLM systems).

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…