Staff Engineer – Risk Management – Post Market

Staff Engineer – Risk Management – Post Market

Requirements

• 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 analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
• Strong communication skills to relay department and area issues, ensuring clarity and cooperation across BD’s global functional teams.

Responsibilities

• Lead cross 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.

Preferred Qualifications

• Technical experience with Pyxis or automated dispensing cabinets (preferred).
• Quality certifications relevant to BD, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.