BD · 22 hours ago
Associate Director, Product Sustaining Engineering
USA RI - Warwick
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Associate Director, Product Sustaining Engineering will lead a team focused on ensuring the reliability and compliance of existing products through lifecycle management and continuous improvement.
Health CareMedical DeviceTechnical Support
Responsibilities
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
Qualification
Required
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field
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 analysis tools and methodologies
Knowledge of DFM/DFA principles
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
Preferred
Master's degree preferred
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase