Job Description Summary

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 MedTech 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. 

Job Summary:
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.

Job Responsibilities:
Team Leadership & Management:

• 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.

Product Lifecycle Management:

• 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.

Continuous Improvement & Optimization:

• 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.

Regulatory Compliance & Risk Management:

• 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.

Cross-Functional Collaboration:

• 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.

Job Qualifications:
Education:

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

Experience:

• 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).

Technical Skills:

• Strong understanding of medical device materials, manufacturing processes, and sterilization methods.
• Experience with statistical analysis tools and methodologies.
• Knowledge of DFM/DFA principles.

Leadership & Soft Skills:

• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving and analytical abilities.
• Ability to manage multiple projects concurrently and prioritize effectively in a fast-paced environment.
• Demonstrated ability to influence and collaborate across various functions and levels of an organization.

At BD, we prioritize on-site collaboration because we believe it fo