Senior Risk Management Engineer

Job Description

A leading medical technology company is seeking a Senior Risk Management Engineer to join the business in a hybrid role which can be at their London or Hampshire site. This organisation develops advanced imaging and guidance systems used in radiation therapy, with a strong global presence and a reputation for innovation and excellence in patient care.

About the Role

This position involves the creation and maintenance of comprehensive Risk Management Files for medical devices, covering both pre- and post-market risk analysis in a fast-paced, agile environment. You will play a key role in ensuring product safety and regulatory compliance throughout the device lifecycle.

Key Responsibilities

• Lead the development and continuous improvement of Risk Management Files in accordance with ISO 14971, including:
• Risk Management Plans
• Hazard Analyses
• Risk Registers
• Benefit-Risk Analyses
• Risk Traceability Matrices
• Change Control and Anomaly Risk Reviews
• Final Risk Management Reports
• Conduct risk assessments for design changes and define appropriate risk controls.
• Collaborate with systems, software, and hardware teams to define and review risk control measures.
• Lead anomaly review boards, assign severity scores, and ensure timely mitigation strategies.
• Analyse post-market surve…