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 fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ