Senior Engineer - Risk Management

BD - San Diego, CA

Full-time - Mid Level

San Diego, CA

Miscellaneous Manufacturing

About the position

The Senior Engineer - Risk Management at BD is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of dispensing medical devices and solutions. This role involves leading cross-functional teams during design, development, and post-market risk management reviews to ensure that all necessary risk management activities are conducted in accordance with quality systems, focusing on patient safety and innovation.

Responsibilities

• Lead remediation efforts for updating risk management documents.
• Facilitate cross-functional discussions with engineering, design, commercial, and product teams to identify hazards and evaluate risks associated with products.
• Monitor the implementation, verification, and validation of risk controls for products in development.
• Develop, maintain, and implement risk management plans in accordance with BD's risk management framework.
• Conduct periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness.
• Evaluate estimated risk and acceptability based on analysis outcomes, utilizing BD's risk acceptance criteria.
• Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk.
• 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.
• Identify opportunities for continuous improvement of the Risk Management Process.

Requirements

• Experience leading remediation efforts is a plus.
• Familiarity with risk management activities that support compliance with international regulatory bodies, including ISO 14971 and ISO 13485.
• Experience in the medical device and/or regulated industry is required.
• Strong communication skills to relay department and area issues clearly across global functional teams.
• Experience with Matlab, Python, JMP/Minitab is a plus.
• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a master's degree preferred.
• Minimum 5 years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors.
• Minimum 5 years leading and applying risk management concepts specifically within the context of medical devices.

Nice-to-haves

• Experience with IEC 60601 and IEC 62304 is a plus.

Benefits

• Competitive salary and compensation package.
• Opportunities for professional development and learning.
• Support for work-life balance with flexible scheduling options.