BD
Overview
The Staff 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 that all necessary risk management activities are executed in accordance with the quality system. This includes risks 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. Job Description:
The Staff 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 the design and development and post-market risk management reviews to ensure that all necessary risk management activities are executed 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 multi-functional discussions with engineering, design, commercial, and product teams to ensure hazards are identified, risks estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
Develop, maintain, and execute risk management plans that support product development and ongoing sustaining activities in accordance with BD’s risk management framework.
Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions, aligned with BD’s quality systems and regulatory standards.
Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
Evaluate estimated risk and acceptability for each risk based on analysis outcomes using BD’s risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with BD’s strategic objectives.
Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
Ensure harmonization of risk management strategies across projects and lifecycle by communicating with other Risk team members.
Identify opportunities for continuous improvement of the Risk Management Process.
Facilitate and provide ongoing training on standards and processes as needed to other associates or functions.
Assist with strategic initiatives and planning.
Mentor and coach other team members and cross-functional teams on risk management processes.
Required Qualifications
Knowledge, Skills & Abilities: Familiarity with risk management activities supporting BD's compliance with international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus.
Experience in a medical device and/or regulated industry (required).
Experience with remediation efforts and FMEA process implementation in medical devices is a plus.
Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
Strong communication skills to relay issues across BD’s global functional teams.
Technical experience with Pyxis or automated dispensing cabinets (preferred).
Minimum Education
Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline); master’s degree preferred.
Quality certifications relevant to BD, such as ASQ Certified Quality Engineer, Certified Auditor, and Six Sigma credentials preferred.
Minimum Experience
8+ years in a regulated industry, particularly within the medical device, biopharmaceutical, or biotechnology sectors, with a preference for experience at BD or similar organizations.
5+ years leading and applying risk management concepts within medical devices to ensure high standards of patient and customer safety.
Work Environment At BD, on-site collaboration is prioritized to foster creativity, innovation, and effective problem-solving in a fast-paced healthcare environment. Most roles require in-office presence, with remote or field-based positions indicated in the posting.
COVID-19 Considerations Employment may be contingent upon proof of full vaccination against COVID-19 where required by location. Testing may be available or required in some locations. BD provides accommodations pursuant to applicable law.
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. We help each other be great, do what’s right, 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 behind our work. We welcome people with imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive.
About BD For more information, visit our careers site at our commitment to you. BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military status, or veteran status.
Salary Information Salary Range: $121,100.00 - $199,800.00 USD Annual
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The Staff 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 that all necessary risk management activities are executed in accordance with the quality system. This includes risks 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. Job Description:
The Staff 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 the design and development and post-market risk management reviews to ensure that all necessary risk management activities are executed 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 multi-functional discussions with engineering, design, commercial, and product teams to ensure hazards are identified, risks estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
Develop, maintain, and execute risk management plans that support product development and ongoing sustaining activities in accordance with BD’s risk management framework.
Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions, aligned with BD’s quality systems and regulatory standards.
Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
Evaluate estimated risk and acceptability for each risk based on analysis outcomes using BD’s risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with BD’s strategic objectives.
Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
Ensure harmonization of risk management strategies across projects and lifecycle by communicating with other Risk team members.
Identify opportunities for continuous improvement of the Risk Management Process.
Facilitate and provide ongoing training on standards and processes as needed to other associates or functions.
Assist with strategic initiatives and planning.
Mentor and coach other team members and cross-functional teams on risk management processes.
Required Qualifications
Knowledge, Skills & Abilities: Familiarity with risk management activities supporting BD's compliance with international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus.
Experience in a medical device and/or regulated industry (required).
Experience with remediation efforts and FMEA process implementation in medical devices is a plus.
Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
Strong communication skills to relay issues across BD’s global functional teams.
Technical experience with Pyxis or automated dispensing cabinets (preferred).
Minimum Education
Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline); master’s degree preferred.
Quality certifications relevant to BD, such as ASQ Certified Quality Engineer, Certified Auditor, and Six Sigma credentials preferred.
Minimum Experience
8+ years in a regulated industry, particularly within the medical device, biopharmaceutical, or biotechnology sectors, with a preference for experience at BD or similar organizations.
5+ years leading and applying risk management concepts within medical devices to ensure high standards of patient and customer safety.
Work Environment At BD, on-site collaboration is prioritized to foster creativity, innovation, and effective problem-solving in a fast-paced healthcare environment. Most roles require in-office presence, with remote or field-based positions indicated in the posting.
COVID-19 Considerations Employment may be contingent upon proof of full vaccination against COVID-19 where required by location. Testing may be available or required in some locations. BD provides accommodations pursuant to applicable law.
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. We help each other be great, do what’s right, 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 behind our work. We welcome people with imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive.
About BD For more information, visit our careers site at our commitment to you. BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military status, or veteran status.
Salary Information Salary Range: $121,100.00 - $199,800.00 USD Annual
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