Systems Engineer - System Development & Integration

Tasks & Responsibilities

Core Systems Engineering & Requirements

• Own requirements engineering, requirements elicitation, and requirements management.
• Drive and coordinate the requirements change control process.
• Contribute to and author development documents, including:
  • Product and technical requirements
  • Traceability analyses and verification documentation
  • Product risk analyses
  • Configuration management documentation
• Collaborate closely on FMEAs, risk analyses, and risk assessments.
• Support system testing during design verification and validation activities.

Cross-Functional Integration & Collaboration

• Facilitate interface management and the creation of interface descriptions.
• Align and coordinate with relevant stakeholders across all systems engineering topics.
• Cooperate cross-functionally with Hardware and Software Engineering, Operations, Customer Support, Clinical Development and Medical Affairs, and Regulatory Affairs.
• Collaborate on the definition, planning, and execution of project tasks and work packages.

AI & Model-Based Systems Engineering

• Ideate and develop LLM agents or similar AI use cases for design, system performance, and documentation analysis.
• Use AI to improve systems engineering artifacts and processes.
• Drive alignment between component development and integration into one system through interface definitions and Model-Based Systems Engineering methodologies.

Must Haves

• Background in development within a regulated environment, ideally in the IVD(R) sector.
• A minimum of three to five years of practical experience in system definition, requirements engineering, systems thinking, and maintaining a big-picture perspective.
• Fundamental knowledge of relevant systems engineering methodologies.
• Experience with and understanding of multiple technology domains, such as electronics, mechanics, and software.
• Clear and structured working style with excellent communication skills.
• Proactive mindset that promotes collaboration within interdisciplinary teams.
• Strong analytical thinking and the ability to see both the big picture and the details, including the separation of requirements and the creation of work breakdown structures.
• Pragmatic approach to problem-solving.
• Strong team-player mentality.
• English proficiency at CEFR B2 level or higher.

Nice to Haves

• Experience combining systems engineering methodologies with artificial intelligence.
• INCOSE or IREB certification.
• Practical experience with SysML or Enterprise Architect.
• Experience in the system integration of complex multidisciplinary systems.
• Bachelor’s or Master’s degree in Mechatronics, Mechanical Engineering, Electrical Engineering, Physics, Biomedical Engineering, Biotechnology, Natural Sciences, or an equivalent discipline.
• Ability to challenge the status quo and work independently.
• German proficiency at CEFR B2 level or higher.