Hard Facts

Tasks & Responsibilities

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.

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.

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.

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.

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.