Senior Engineer Risk Management

$99,000 - $163,300/Yr

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 ensuring compliance with risk management requirements throughout the life cycle of dispensing medical devices. This role involves leading cross-functional teams in risk management activities, ensuring that all necessary processes are executed in accordance with quality systems, and supporting BD's commitment to innovation and patient safety.

Responsibilities

• Lead remediation efforts for updating risk management documents.
• Facilitate cross-functional discussions to identify hazards associated with products and ensure risks are documented and controlled.
• Monitor implementation and verification of risk controls for products in development.
• Develop and execute risk management plans in accordance with BD's risk management framework.
• Conduct periodic reviews of the risk management process and document decisions and actions taken.
• Evaluate estimated risk and acceptability based on analysis outcomes and BD's risk acceptance criteria.
• Support the Benefit-Risk Analysis process and lead evaluations of overall residual risk.
• Perform and document Risk Reviews to communicate results 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

• 5+ years in a regulated industry, particularly within medical device, bio-pharmaceutical, or biotechnology sectors.
• 5+ years leading and applying risk management concepts specifically within the context of medical devices.
• Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline); master's degree preferred.
• Experience in medical device and/or regulated industry is required.
• Strong communication skills to relay department and area issues across global functional teams.

Nice-to-haves

• Experience leading remediation efforts is a plus.
• Familiarity with risk management activities supporting compliance with international regulatory bodies, including ISO 14971 and ISO 13485.
• Experience with IEC 60601 and IEC 62304 is a plus.
• Experience with Matlab, Python, JMP/Minitab is a plus.

Benefits

• Competitive salary range of $99,000.00 - $163,300.00 USD annually.
• Opportunities for professional development and learning.
• Rewards and recognition programs that promote a performance-based culture.