As the System Engineer in the technical team, you will play a critical role in the design, development, and integration of the Bambi Belt Solution. You will collaborate with cross-functional team-members, including regulatory, quality assurance, hardware-, and software engineers, to ensure that our products meet the highest standards for safety, performance, and regulatory compliance. Your expertise will drive the successful delivery of complex medical systems from concept through to production.

• Lead the design, development, and integration of the Bambi Belt Solution.
• Define system requirements and ensure they are met across the development lifecycle.
• Develop and maintain system architecture, ensuring integration of hardware, software, and other subsystems.
• Conduct risk management activities, including risk analysis and mitigation in compliance with ISO 14971 and FDA regulations.
• Develop system-level testing plans and participate in the validation of medical devices.
• Coordinate with cross-functional teams to ensure product design meets both functional and regulatory requirements.
• Ensure system design and documentation comply with industry standards, regulatory requirements (MDR, IEC 60601, etc.), and internal guidelines.
• Support design reviews and provide input on system performance, reliability, and safety.
• Troubleshoot and resolve system-level issues that arise during development, testing, and production.

• Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechatronics Engineering or a related field.
• Proven experience in system engineering, preferably in the medical device industry.
• Strong understanding of medical device regulatory standards (MDR, ISO 13485, IEC 60601, ISO 14971).
• Knowledge of the full product development lifecycle from concept to post-market.
• Proficiency in system design, architecture, and integration.
• Familiarity with embedded systems, hardware, and software integration.
• Strong analytical and problem-solving skills, with the ability to work in a highly regulated environment.
• Excellent communication and teamwork skills to collaborate effectively with multidisciplinary teams.

• Experience with Agile development methodologies.
• Knowledge of medical device cybersecurity standards and practices.
• Certifications in systems engineering or medical device regulations.
• Familiarity with design control processes and documentation tools (e.g., Arena, Aligned Elements,..).

• Competitive salary and benefits.
• Opportunity to work on life-changing medical technologies.
• A collaborative and supportive work environment.
• A chance to contribute to products that have a direct impact on patient care.

Interested candidates should submit their resume and cover letter to info@bambi-medical.com.