Systems Engineer System Development & Integration (m/f/d)

Responsibilities

• Own Requirements Engineering and Elicitation as well as Requirements Management and drive and coordinate the requirements change control process
• Contribute to and author development documents, such as: Product/Technical requirements, Traceability analysis (verification), Product risk analysis, and configuration management
• Collaborate heavily during FMEA and risk analysis/assessments
• Support system testing during design verification and validation activities
• Facilitate interface management and descriptions and align and coordinate with affected parties across all systems engineering topics
• Cooperate cross-functionally with HW and SW Engineering, Operations, Customer Support, Clinical Development and Medical Affairs, and Regulatory Affairs
• Collaborate during the definition, planning, and execution of project tasks and work packages
• Ideate and develop LLM agents or similar AI use cases for design, system performance, and documentation analysis to improve systems engineering artifacts and processes
• Drive alignment between component development and integration into one system via interface definitions and MBSE methodologies

Profile

• Background in development within a regulated environment, ideally in the IVD(R) area with extended and pratical experience in system definition, applying requirements engineering skills, acting as a systems thinker, and focusing on the "big picture"
• Fundamental knowledge of relevant methodologies used in systems engineering 
• Experience with and understanding of multiple technology domains (e.g., Electronics, Mechanics, and SW) • Clear and structured working style with excellent communication skills
• Proactive mindset that promotes collaboration within interdisciplinary teams
• Analytical thinking; ability to see both the big picture and the details (e.g., separation of requirements, work breakdown structures)
• Pragmatic approach to problem-solving and strong team player
• Fuency in English, German is an advantage
• Experience combining systems engineering methodologies with artificial intelligence
• INCOSE or IREB certification
• Practical experience with SysML in general or Enterprise Architect in particular

Benefits

• Dynamic and innovative market environment
• A very renowned company