Associate Director, Product Sustaining Engineering

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.

Job 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 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 Associate Director, Product Sustaining Engineering will lead and manage a team responsible for ensuring the ongoing reliability, performance, and compliance of Davol's existing product portfolio through lifecycle management, continuous improvement, and technical support.

• Lead, mentor, and develop a team of sustaining engineers, fostering a culture of technical excellence, collaboration, and accountability.
• Manage resource allocation, project prioritization, and performance reviews for the sustaining engineering team.
• Drive best practices in sustaining engineering processes and methodologies.

• Oversee and execute engineering changes (ECRs/ECOs) for existing products, ensuring thorough analysis, robust design solutions, and compliant implementation.
• Manage product obsolescence, end-of-life planning, and transition strategies.
• Lead technical investigations for product issues, CAPAs, and field complaints, driving root cause analysis and effective corrective/preventive actions.

• Identify and implement design improvements, cost reductions, and manufacturing efficiencies for existing products without compromising quality or regulatory compliance.
• Collaborate with manufacturing, quality, and supply chain teams to resolve production issues and enhance product manufacturability.
• Monitor product performance data, identify trends, and proactively address potential issues.

• Ensure all sustaining engineering activities adhere to relevant medical device regulations (e.g., FDA QSR, ISO 13485), internal quality systems, and company policies.
• Participate in risk management activities, including FMEAs and hazard analyses, to assess and mitigate risks associated with product changes.
• Support regulatory submissions and audits as needed.

• Serve as a key technical liaison with R&D, Quality, Manufacturing, Regulatory Affairs, and Clinical teams.
• Communicate effectively with stakeholders regarding project status, technical challenges, and product performance.

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.
• Master's degree preferred.

• Minimum of 8 years of experience in product development, sustaining engineering, or a related engineering role within the medical device industry.
• Minimum of 5 years of experience in a leadership or management role, leading technical teams.
• Textile experience.
• Demonstrated experience with medical device design control, risk management, and regulatory requirements (FDA QSR, ISO 13485).
• Proven track record of managing engineering changes (ECRs/ECOs) and product lifecycle activities.
• Experience with root cause analysis methodologies (e.g., 8D, Fishbone, 5 Whys).

• Strong understanding of medical device materials, manufacturing processes, and sterilization methods.
• Experience with statistical…