Senior Risk Management Engineer

Halian Technology Limited; Watford; Hybrid; GBP 60,000 - 75,000; Full time

Job summary

A leading medical technology company is looking for a Senior Risk Management Engineer for a hybrid role in Watford, UK. This position involves developing Risk Management Files, conducting risk assessments for medical devices, and ensuring product safety compliance. Qualified candidates will have over 5 years of experience in a regulated environment and a strong grasp of ISO standards. This role offers a chance to influence risk management practices and requires occasional travel. A competitive salary and benefits are provided.

Qualifications

• 5+ years experience in risk management for medical devices.
• Understanding of ISO 14971 and post-market risk analysis.
• Strong communication and organisational skills.

Responsibilities

• Develop and improve Risk Management Files according to ISO 14971.
• Conduct risk assessments for design changes.
• Analyze post-market surveillance data for trend identification.

Skills

Risk management for medical devices

ISO 14971 knowledge

Post-market risk analysis

Strong analytical skills

Fluent in English

Tools

Microsoft Office

ALM tools (Polarion, MatrixALM, DOORS)

Job description

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 surveillance data (e.g., complaints, field performance, adverse events) to identify trends and initiate corrective actions.
• Support regulatory submissions and audits by ensuring risk documentation is inspection-ready.
• Contribute to the development of internal risk management processes and tools.
• Occasional UK and international travel may be required.

Essential Skills & Experience

• 5+ years of experience in risk management for medical devices, ideally in a regulated Class II or III environment.
• Deep knowledge of ISO 14971 and ISO/TR 24971, with practical application across the product lifecycle.
• Strong understanding of IEC 62304 (software lifecycle) and ideally IEC 60601 (electrical safety).
• Experience in post-market risk analysis and trend evaluation using real-world data.
• Strong analytical, organisational, and communication skills.
• Comfortable working in a global, cross-functional environment.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Fluent in written and spoken English.

Desirable Skills & Experience

• Familiarity with IEC 62366-1 (Usability Engineering) and IEC 60601-1-2 (EMC).
• Experience in Agile development environments.

Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies).

Proficiency with ALM tools such as Polarion, MatrixALM, DOORS, or Enterprise Architect.