Senior Systems Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304)

Senior Systems Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304)

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Product Risk Manager | Surface Guided Radiation Therapy | VisionRT Ltd | SiMD and SaMD

Vision RT is a rapidly growing MedTech which is transforming radiation therapy for cancer patients, helping to make it more accurate, effective and comfortable. We are the inventors of, and the market leaders in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, for more guidance across every step of the radiotherapy workflow. Our SGRT solutions are used in 24 out of the 25 Best Hospitals for Cancer, as tracked by US News & World Report. Were one of Britains fastest-growing private tech companies, as recently recognised by the 2025 Sunday Times 100 Tech list. Were also the proud winners of a 2024 Kings Award for Enterprise, the UKs most prestigious accolade for business excellence. Company video With around 300 employees globally, and offices in the UK, Poland & the USA, Vision RT operates independently as part of the Danish company William Demant Invest A/S - one of the worlds largest investors in healthcare companies. Vision RT staff members have the security and reach that comes with being part of a large global enterprise, combined with the freedom and agility of a startup. This is a company with strong values, a clear mission and a bright future. Its an exciting and rewarding place to work.

About The Role

This role sits with the compliance team and involves creating and maintaining Risk Management files for Vision RT medical devices, including pre and post-market risk analysis in an agile landscape.

As a Senior Risk Management Engineer at Vision RT, you will play a critical role in ensuring the safety and compliance of our medical devices throughout their lifecycle.

Key Responsibilities Will Include

• Leading the creation, maintenance, and continuous improvement of comprehensive Risk Management Files in accordance with ISO 14971, including:
• Risk Management Plans
• Hazard Analyses
• Risk Registers
• Benefit-risk Analysis
• Risk Traceability Matrices
• Change Control and Anomaly Risk Reviews
• Final Risk Management Reports
• Driving risk assessments for design changes, ensuring appropriate risk controls are identified and implemented.
• Defining and reviewing risk control measures as design inputs, collaborating closely with systems, software, and hardware teams.
• Leading anomaly review boards, assigning severity scores, and ensuring timely risk mitigation strategies are in place.
• Conducting in-depth risk reviews of post-market surveillance data, including complaints, field performance, and adverse event reports, to identify trends and initiate corrective actions.
• Supporting regulatory submissions and audits by ensuring risk documentation is inspection-ready and aligned with global regulatory expectations.
• Contributing to the development and refinement of internal risk management processes and tools.
• Occasional UK and international travel may be required.
  
  

• Proven experience (typically 5+ years) in risk management for medical devices, ideally in a regulated Class II or III environment.
• Deep, practical knowledge of ISO 14971 and ISO/TR 24971, with a track record of applying these standards across the product lifecycle.
• Strong understanding of IEC 62304 (software lifecycle) and ideally IEC 60601 (electrical safety).
• Demonstrated experience in post-market risk analysis, including trend analysis and risk re-evaluation based on real-world data.
• Proficiency with application lifecycle management (ALM) tools such as Polarion, MatrixALM, DOORS, or Enterprise Architect.
• Strong analytical and organizational skills, with the ability to manage multiple priorities and deadlines.
• Excellent communication skills, including the ability to present complex risk concepts to cross-functional teams and senior stakeholders.
• Comfortable working in a global, cross-functional environment, with a collaborative and proactive mindset.
• Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
• Fluent in written and spoken English.
  
  

• Familiarity with additional standards such as: IEC 62366-1 (Usability Engineering) & IEC 60601-1-2 (EMC)
• Experience working in Agile development environments.
• Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies).
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Construction

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