Associate Director Of R&D
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, and demonstrated operational excellence in a regulated environment.
Key responsibilities include :
- Lead a high-performing R&D focused on new product development, commercialization, and 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.
- 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.
- 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.
- 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 include :
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 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.
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