BD Nogales Norte
Overview
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 operating excellence in a regulated environment. Key Responsibilities
Team Development / People Leadership: Lead a high-performing R&D focused on new product development, commercialization, and post-commercialization support. 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. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and 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 and 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. For more information about BD, visit the official careers page at
https://bd.com/careers .
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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 operating excellence in a regulated environment. Key Responsibilities
Team Development / People Leadership: Lead a high-performing R&D focused on new product development, commercialization, and post-commercialization support. 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. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and 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 and 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. For more information about BD, visit the official careers page at
https://bd.com/careers .
#J-18808-Ljbffr