BD
Overview
Join to apply for the
Senior Engineer - Risk Management
role at
BD . BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes imagination and passion—from design and engineering to manufacturing and marketing of our MedTech products—to look at the impossible and turn dreams into possibilities. Join us to learn, grow, and become your best self in an environment where you are supported by global teams. Job Description
The
Senior Engineer – Risk Management
is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of BD\'s dispensing medical devices and solutions. They will lead cross-functional teams during design, development, and post-market risk management reviews to ensure all necessary risk management activities are driven in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach cross-functional teams on risk management processes that support BD\'s commitment to innovation and patient safety. Responsibilities
Lead cross-functional discussions with engineering, design, commercial, and product teams to identify hazards, estimate risks, and document controls. Monitor that risk controls are implemented, verified, and validated for products in development; verify the effectiveness of risk control measures throughout the product life cycle. Develop, maintain, and execute comprehensive risk management files (e.g., Risk Management Plan, Risk Management Report, Risk Reviews, System Hazard Analysis, Hazard and Harm Analysis, dFMEA, pFMEA, uFMEA). Drive implementation and validation of risk controls throughout the product lifecycle. Lead periodic risk reviews and ensure documentation aligns with BD\'s quality systems. Develop and execute risk management plans to support product development and ongoing sustaining activities in BD\'s risk management framework. Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and compliance with regulatory standards and practices. Lead remediation efforts for updating risk management documents and the FMEA process. Evaluate estimated risk and acceptability using BD\'s risk acceptance criteria; lead efforts to identify and document risk control methods when risks are not acceptable. Support the Benefit-Risk Analysis process and lead evaluation of overall residual risk, aligned with BD\'s objectives. Perform and document Risk Reviews to communicate results to cross-functional teams. Harmonize risk management strategies across projects and lifecycles by communicating with Risk team members. Identify opportunities for continuous improvement of the Risk Management Process. Facilitate and provide ongoing training on standards/processes as needed to other associates or functions. Assist with strategic initiatives and planning; mentor and coach others on risk management processes. Required Qualifications
Knowledge, Skills & Abilities
Experience leading remediation efforts is a plus. Familiarity with risk management activities that support BD\'s compliance with ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus. Experience in medical device and/or regulated industry (required). Strong communication skills to relay issues across global teams. Experience with Matlab, Python, JMP/Minitab is a plus. Minimum Educational Level
Bachelor of Science in engineering (Mechanical, Electrical, Materials, Biomedical, or related); master’s degree preferred. Minimum Experience
Minimum 5 years in a regulated industry, preferably within medical devices, biotech, or related fields; strong preference for experience at BD or similar organizations. Minimum 5 years leading and applying risk management concepts for medical devices with emphasis on patient and customer safety. At BD, on-site collaboration is valued; most roles require a minimum of 4 days on-site per week. Remote or field positions will have different arrangements. Employment may be contingent on proof of full COVID-19 vaccination where required by location; accommodations are considered per policy and applicable law. Why Join Us?
BD offers a team-oriented environment that values your opinions and contributions. We encourage you to bring your authentic self to work, support growth, accountability, and continuous improvement. We invite you to help reinvent the future of health. Learn more about BD at
https://bd.com/careers . Equal Opportunity Employer
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 status, or other legally-protected characteristics.
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Join to apply for the
Senior Engineer - Risk Management
role at
BD . BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes imagination and passion—from design and engineering to manufacturing and marketing of our MedTech products—to look at the impossible and turn dreams into possibilities. Join us to learn, grow, and become your best self in an environment where you are supported by global teams. Job Description
The
Senior Engineer – Risk Management
is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of BD\'s dispensing medical devices and solutions. They will lead cross-functional teams during design, development, and post-market risk management reviews to ensure all necessary risk management activities are driven in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach cross-functional teams on risk management processes that support BD\'s commitment to innovation and patient safety. Responsibilities
Lead cross-functional discussions with engineering, design, commercial, and product teams to identify hazards, estimate risks, and document controls. Monitor that risk controls are implemented, verified, and validated for products in development; verify the effectiveness of risk control measures throughout the product life cycle. Develop, maintain, and execute comprehensive risk management files (e.g., Risk Management Plan, Risk Management Report, Risk Reviews, System Hazard Analysis, Hazard and Harm Analysis, dFMEA, pFMEA, uFMEA). Drive implementation and validation of risk controls throughout the product lifecycle. Lead periodic risk reviews and ensure documentation aligns with BD\'s quality systems. Develop and execute risk management plans to support product development and ongoing sustaining activities in BD\'s risk management framework. Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and compliance with regulatory standards and practices. Lead remediation efforts for updating risk management documents and the FMEA process. Evaluate estimated risk and acceptability using BD\'s risk acceptance criteria; lead efforts to identify and document risk control methods when risks are not acceptable. Support the Benefit-Risk Analysis process and lead evaluation of overall residual risk, aligned with BD\'s objectives. Perform and document Risk Reviews to communicate results to cross-functional teams. Harmonize risk management strategies across projects and lifecycles by communicating with Risk team members. Identify opportunities for continuous improvement of the Risk Management Process. Facilitate and provide ongoing training on standards/processes as needed to other associates or functions. Assist with strategic initiatives and planning; mentor and coach others on risk management processes. Required Qualifications
Knowledge, Skills & Abilities
Experience leading remediation efforts is a plus. Familiarity with risk management activities that support BD\'s compliance with ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus. Experience in medical device and/or regulated industry (required). Strong communication skills to relay issues across global teams. Experience with Matlab, Python, JMP/Minitab is a plus. Minimum Educational Level
Bachelor of Science in engineering (Mechanical, Electrical, Materials, Biomedical, or related); master’s degree preferred. Minimum Experience
Minimum 5 years in a regulated industry, preferably within medical devices, biotech, or related fields; strong preference for experience at BD or similar organizations. Minimum 5 years leading and applying risk management concepts for medical devices with emphasis on patient and customer safety. At BD, on-site collaboration is valued; most roles require a minimum of 4 days on-site per week. Remote or field positions will have different arrangements. Employment may be contingent on proof of full COVID-19 vaccination where required by location; accommodations are considered per policy and applicable law. Why Join Us?
BD offers a team-oriented environment that values your opinions and contributions. We encourage you to bring your authentic self to work, support growth, accountability, and continuous improvement. We invite you to help reinvent the future of health. Learn more about BD at
https://bd.com/careers . Equal Opportunity Employer
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 status, or other legally-protected characteristics.
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