BD
Overview
Business Process Owner, Risk Management (Dispensing) at BD. This role focuses on influencing risk management process activities for product development and product maintenance, applying quality management and engineering skills for medical devices. The role supports engineers from product inception through launch and maintenance, ensuring products meet quality standards and regulatory requirements. The position may assist with compliance remediation, design control, change control, and broader product development process management projects. Responsibilities
Owns and ensures Product Risk Management is effectively implemented within the Dispensing and Software Technology Solutions (STS) business units Work with the Risk Management BPO for Infusion and Product Development Process leadership to maintain a comprehensive risk management program across the MMS business unit Participate on a team bringing core product development and post-market business processes to the MMS business Serve as subject matter authority on Product Risk Management Lead continuous process improvements and partner with SMEs on key initiatives Ensure consistent application of product risk management activities across all elements of the Quality System (e.g., CAPA, Field Actions) Establish training requirements and orchestrate training for Product Risk Management Monitor performance of Product Risk Management and report to senior leadership Benchmark trends in the industry, identify best practices and deploy at BD Monitor industry surveillance audit outcomes and take actions to align processes with new or revised regulatory requirements Monitor internal and external audit observations, identify causes and implement fixes across the enterprise for Product Risk Management Work with standards committees to monitor external regulatory changes and determine need for policy changes, implementing where appropriate Support regulatory inspections and audits Participate in collaborative communities (cross-site/cross-functional SMEs) to support and drive change Education and Experience
Requires a minimum of a BS/MS degree in life science, engineering or related discipline; experience with both hardware and software applications preferred At least 8 years of experience in a Class I/II/III medical device with specific experience in Risk Management Experience interpreting and applying ISO 14971, FDA CFR 820.30 and other regulations related to Product Risk Management Demonstrated experience establishing global Quality strategy and oversight at business/manufacturing site level in a global company Strong background in Risk Management related to product design, development, and post-market activities Strong understanding of design control requirements and regulation Proven ability as a change agent to drive improvements across a large organization Strong technical writing and communication skills, with ability to interface with senior leaders Understanding of quality systems applied to the medical device industry Ability to work globally, lead a global team, and influence across cultures and regions Travel is required; level varies with business needs Work Arrangement
BD emphasizes on-site collaboration as part of its culture. Most roles require in-office presence, with flexibility where applicable. Remote or field-based arrangements will be indicated in the job posting. This role is a temporary assignment including benefits (medical, health, dental, 401k) based on eligibility under the BD Total Rewards policy, and is anticipated to last through March 31, 2026. Why Join Us?
BD values your opinions and contributions, supports you to learn and grow, and fosters accountability and improvement. BD aims to help you see the bigger picture and reinvent the future of health. You will have opportunities to learn, grow, and contribute to meaningful outcomes. To learn more about BD, visit https://bd.com/careers Equal Opportunity
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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Business Process Owner, Risk Management (Dispensing) at BD. This role focuses on influencing risk management process activities for product development and product maintenance, applying quality management and engineering skills for medical devices. The role supports engineers from product inception through launch and maintenance, ensuring products meet quality standards and regulatory requirements. The position may assist with compliance remediation, design control, change control, and broader product development process management projects. Responsibilities
Owns and ensures Product Risk Management is effectively implemented within the Dispensing and Software Technology Solutions (STS) business units Work with the Risk Management BPO for Infusion and Product Development Process leadership to maintain a comprehensive risk management program across the MMS business unit Participate on a team bringing core product development and post-market business processes to the MMS business Serve as subject matter authority on Product Risk Management Lead continuous process improvements and partner with SMEs on key initiatives Ensure consistent application of product risk management activities across all elements of the Quality System (e.g., CAPA, Field Actions) Establish training requirements and orchestrate training for Product Risk Management Monitor performance of Product Risk Management and report to senior leadership Benchmark trends in the industry, identify best practices and deploy at BD Monitor industry surveillance audit outcomes and take actions to align processes with new or revised regulatory requirements Monitor internal and external audit observations, identify causes and implement fixes across the enterprise for Product Risk Management Work with standards committees to monitor external regulatory changes and determine need for policy changes, implementing where appropriate Support regulatory inspections and audits Participate in collaborative communities (cross-site/cross-functional SMEs) to support and drive change Education and Experience
Requires a minimum of a BS/MS degree in life science, engineering or related discipline; experience with both hardware and software applications preferred At least 8 years of experience in a Class I/II/III medical device with specific experience in Risk Management Experience interpreting and applying ISO 14971, FDA CFR 820.30 and other regulations related to Product Risk Management Demonstrated experience establishing global Quality strategy and oversight at business/manufacturing site level in a global company Strong background in Risk Management related to product design, development, and post-market activities Strong understanding of design control requirements and regulation Proven ability as a change agent to drive improvements across a large organization Strong technical writing and communication skills, with ability to interface with senior leaders Understanding of quality systems applied to the medical device industry Ability to work globally, lead a global team, and influence across cultures and regions Travel is required; level varies with business needs Work Arrangement
BD emphasizes on-site collaboration as part of its culture. Most roles require in-office presence, with flexibility where applicable. Remote or field-based arrangements will be indicated in the job posting. This role is a temporary assignment including benefits (medical, health, dental, 401k) based on eligibility under the BD Total Rewards policy, and is anticipated to last through March 31, 2026. Why Join Us?
BD values your opinions and contributions, supports you to learn and grow, and fosters accountability and improvement. BD aims to help you see the bigger picture and reinvent the future of health. You will have opportunities to learn, grow, and contribute to meaningful outcomes. To learn more about BD, visit https://bd.com/careers Equal Opportunity
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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