JOB DESCRIPTION

As a Senior Systems Engineer you will contribute to the creation and maintenance of high-quality products, meeting user, business and regulatory requirements. You will manage complexity and show technical leadership and effective stakeholder management.

YOUR ROLE:

• You will be an expert leading our teams in the domain of product safety risk management
• You are part of the Systems Engineering group in MR R&D
• You will oversee the engineering team’s execution to ensure designs meet criteria for quality, safety and reliability, while maintaining comprehensive risk management related documentation and advancing system engineering practices
• You will conduct risk assessments, implement control measures, and support regulatory submissions to align with medical standards and ensure product safety throughout the life cycle, including support of complaint investigations and post-market surveillance
• You are aware of ISO 14971 and its implications for medical device development and are comfortable communicating and implementing the standard in your work context.
• You are able to work with industry standard document management systems.
• You are comfortable using office tooling to create and maintain documentation.