System Engineer

As a System Engineer, your responsibilities typically involve overseeing the system's planning, implementation, and maintenance, particularly related to development, production, and quality assurance.

Your Role:

• Oversee the design and integration of the system.
• Coordinate with cross-functional teams, including hardware, software, and regulatory teams, to achieve project goals.
• Ensure that system engineering processes align with regulatory standards.
• Implement and manage risk management processes throughout the development lifecycle.
• Identify potential risks and develop mitigation strategies to ensure product safety and efficacy.
• Define the system requirements, ensuring meeting customer needs and regulatory requirements.
• Develop and implement verification and validation plans to ensure functionality and safety
• Work closely with regulatory affairs teams to ensure meeting relevant regulatory standards and requirements.
• Provide support during regulatory submissions and audits.
• Identify opportunities for process improvement and implement best practices in system engineering.

Qualifications

• Bachelor’s or master’s degree in engineering or a related field.
• At least 5 years of experience in system engineering within the medical device industry.
• In-depth knowledge of regulatory requirements for medical devices (e.g., FDA)
• Proficiency in system design, integration, and verification/validation processes.
• Ability to collaborate with cross-functional teams and manage multiple projects simultaneously.
• Fluent English