BD (Tissuemed Ltd)
Overview
Associate Director, R&D at BD (Tissuemed Ltd). We are seeking a detail-oriented and strategic leader to guide an engineering team focused on design verification, product lifecycle management, and sustaining engineering for a diverse product portfolio. This role ensures the safety, efficacy, and continuous improvement of our products throughout their lifecycle. The ideal candidate demonstrates talent development, technical expertise, regulatory knowledge, and operational excellence in a regulated environment. Key Responsibilities
Team Development / People Leadership:
Lead a high-performing R&D team involved in new product development, commercialization, and post-commercialization support within UCC; drive engineering excellence across multiple product families with emphasis on reliability, manufacturability, and patient safety; manage engineering project resourcing, timelines, and budgets across concurrent development programs; mentor and develop engineering talent and foster a culture of innovation, continuous improvement, and technical rigor. Design Verification & Validation (V&V):
Plan, execute, and document 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. Work Environment & Compliance
BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is typical to maintain our culture and operations; flexible arrangements may apply per job posting. Employment may be contingent upon proof of full COVID-19 vaccination where required by location, with accommodations considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages authenticity, and supports growth. We aim to reinvent the future of health and provide opportunities to learn, grow, and contribute to meaningful outcomes. To learn more about BD, visit https://bd.com/careers Additional Information
BD 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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, or veteran status, and other legally-protected characteristics. Required Skills
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Associate Director, R&D at BD (Tissuemed Ltd). We are seeking a detail-oriented and strategic leader to guide an engineering team focused on design verification, product lifecycle management, and sustaining engineering for a diverse product portfolio. This role ensures the safety, efficacy, and continuous improvement of our products throughout their lifecycle. The ideal candidate demonstrates talent development, technical expertise, regulatory knowledge, and operational excellence in a regulated environment. Key Responsibilities
Team Development / People Leadership:
Lead a high-performing R&D team involved in new product development, commercialization, and post-commercialization support within UCC; drive engineering excellence across multiple product families with emphasis on reliability, manufacturability, and patient safety; manage engineering project resourcing, timelines, and budgets across concurrent development programs; mentor and develop engineering talent and foster a culture of innovation, continuous improvement, and technical rigor. Design Verification & Validation (V&V):
Plan, execute, and document 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. Work Environment & Compliance
BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is typical to maintain our culture and operations; flexible arrangements may apply per job posting. Employment may be contingent upon proof of full COVID-19 vaccination where required by location, with accommodations considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages authenticity, and supports growth. We aim to reinvent the future of health and provide opportunities to learn, grow, and contribute to meaningful outcomes. To learn more about BD, visit https://bd.com/careers Additional Information
BD 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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, or veteran status, and other legally-protected characteristics. Required Skills
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