Safety Engineer

Overview

In this role you ensure medical devices are safe, effective, and secure across their lifecycle. You’ll partner with System Engineers and cross-functional teams to champion safety during development, manage risk files, and drive process improvements to meet regulatory obligations. You’ll translate risk insights into clear actions guiding product releases and lifecycle monitoring. The position offers the chance to impact patient care on a global scale through compliant, safe medical devices. You will work in a mission-driven environment that values collaboration and continuous improvement.

Pay / Benefits

• Up to 25 vacation days
• Private Medical Insurance
• Attractive Pension Contribution Package
• Cycle to work scheme
• Onsite subsidized restaurant
• Electric vehicle salary sacrifice scheme

Responsibilities

• Lead and support product risk management across the development lifecycle
• Identify risks, assess impact, and implement mitigations to acceptable levels
• Review and document risk management activities with recommendations for release decisions
• Ensure conformity with regulatory and risk management requirements
• Collaborate with cross-functional teams to embed safety into design and development
• Prepare and maintain risk management reports and monitoring activities, including post-market reviews

Key requirements

• Degree in Engineering, Life Sciences, or related discipline, or equivalent experience
• Experience in product safety, risk management, or related field in the medical device industry
• Solid understanding of risk management principles across the product lifecycle
• Knowledge of medical device regulations and working in a highly regulated environment
• Experience interpreting standards/regulations: ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, MDR
• Strong communication and collaboration across diverse teams

• Strong communication
• Collaborative
• Cross-functional teamwork
• Risk management principles
• Regulatory compliance for medical devices
• Knowledge of ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, MDR, NMPA

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