Job Description Summary

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 supports BD's commitment to innovation and patient safety.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

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 supports BD's commitment to innovation and patient safety.

Responsibilities:

• Lead multi-functional discussions such as with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are 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 taken, aligned with BD’s quality systems and ensuring compliance with regulatory standards and practices.

• 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, utilizing 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 their 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/processes as needed to other associates or functions.

• Assist with strategic initiatives and planning.

• Mentor and coach other members on the team and cross functional teams on risk management processes.

REQUIRED QUALIFICATIONS:

Knowledge, Skills & Abilities:

• Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience a plus.

• Experience in medical device and/or regulated industry (required).

• Experience with remediation efforts and FMEA process implementation with medical devices is a plus.

• Ability to anal