Job Description Summary

We are seeking a detail-oriented and strategic Associate Director of R&D to lead an engineering team focused on design verification, product lifecycle management, and sustaining engineering for a diverse product portfolio. This role is critical to ensure the safety, efficacy, and continuous improvement of our products throughout the lifecycle. The ideal candidate brings a passion for talent development, technical expertise, regulatory knowledge, & demonstrated operational excellence in a regulated environment.

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. 

Position Summary:

We are seeking a detail-oriented and strategic Associate Director of R&D to lead an engineering team focused on design verification, product lifecycle management, and sustaining engineering for a diverse product portfolio. This role is critical to ensure the safety, efficacy, and continuous improvement of our products throughout the lifecycle. The ideal candidate brings a passion for talent development, technical expertise, regulatory knowledge, & demonstrated operational excellence in a regulated environment.

Key Responsibilities:

Team Development / People Leadership:

• Lead a high-performing R&D focused new product development, commercialization, & post-commercialization support within UCC.

• Drive engineering excellence across multiple product families, emphasizing reliability, manufacturability, and patient safety.

• Manage engineering project resourcing, timelines, and budgets across concurrent development programs.

• Mentor and develop engineering talent; foster a culture of innovation, continuous improvement, and technical rigor.

Design Verification & Validation (V&V):

• Lead the planning, execution, and documentation of design verification and validation activities in compliance with FDA and ISO standards.

• Develop and review test protocols, reports, and traceability matrices to ensure design inputs are met.

• Collaborate with quality, regulatory, and engineering teams to ensure robust risk management and design control practices (21 CFR Part 820, ISO 13485, ISO 14971).

• Support root cause analysis and corrective actions for test failures or non-conformances.

Product Lifecycle Management (PLM):

• Oversee the R&D aspects of the product lifecycle from concept through end-of-life, ensuring smooth transitions between development, launch, and post-market phases.

• Manage product design changes, design history files (DHFs), and technical documentation in alignment with QMS & ERP systems.

• Partner with cross-functional teams to implement product updates, cost improvements, and regulatory changes.

Sustaining Engineering:

• Lead sustaining engineering efforts to support existing products, including design improvements, component obsolescence, and manufacturing support.

• Drive continuous improvement initiatives to enhance product quality, reliability, and manufacturability.

• Serve as a technical liaison between R&D, manufacturing, quality, and customer support teams.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (Master’s or Ph.D. preferred).

• 10+ years of experience in medical device R&D, with at least 5 years in a people leadership or management role.

• Proven experience in design verification, sustaining engineering, and product lifecycle management.

• Strong knowledge of regulatory requirements and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304/60601 as applicable).

• Willingness to travel globally up to 20% of time.

• Excellent leadership, communication, and cross-functional collaboration skills.

At BD, we prioritize on-site collaboration because we be