Systems Engineer

Systems Engineer (m/f/d) - IVD(R) / systems engineering / development / regulated environment

Background: Join us in shaping the future of critical care diagnostics. Blood gas & electrolyte (BGE) analysis is used in critical point-of-care settings where time and quality matter. NPC R&D BGE is responsible for the development of new and improved BGE analysis systems and the life cycle maintenance of existing BGE products. Within NPC R&D, System Development and Integration is where everything comes together: a team of dedicated scientists, engineers, and lab technicians ensures that hardware and software fit together seamlessly with sensor and reagent technologies to form robust and reliable BGE analysis systems.

We are looking for a new team member in our Systems Engineering group to help us ensure the development success of our complex diagnostics systems, consisting of fluidics, software, instruments, biochemical sensors, and reagents. In this role, you will own and manage system-level topics and documentation, mainly in the form of requirements engineering, interface management, conceptual work, and change control management. Furthermore, you will support the alignment and integration of different system components using Model-Based Systems Engineering and champion the use of agentic AI in requirements engineering.

The Perfect Candidate for this role possesses a background in development within a regulated environment, preferably in the IVD(R) sector, and has 3-5 years of practical experience in system definition, requirements engineering, and systems thinking. They should demonstrate a strong grasp of systems engineering methodologies and an understanding of multiple technology domains, including electronics, mechanics, and software. Additionally, the candidate should exhibit a clear and structured working style, proactive collaboration skills, and the ability to maintain both a big-picture perspective and attention to detail.

Tasks & Responsibilities:

Core Systems Engineering & Requirements

• Own Requirements Engineering and Elicitation as well as Requirements Management.
• 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.

Cross-Functional Integration & Collaboration

• Facilitate interface management and descriptions.
• 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.

Innovation: AI & Model-Based Systems Engineering (MBSE)

• 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.

Must Haves:

• Background in development within a regulated environment, ideally in the IVD(R) area
• 3-5 years of practical 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
• Strong team player
• English - Advanced CEFRL B2

Nice to haves:

• Experience combining systems engineering methodologies with artificial intelligence.
• INCOSE or IREB certification.
• Practical experience with SysML in general or Enterprise Architect in particular.
• Experience in the system integration of complex multidisciplinary systems.
• Bachelor / Master (BSc/MSc) in Mechatronics, Mechanical/Electrical Engineering, Physics, Biomedical Engineering, Biotechnology, natural sciences, or equivalent.
• Ability to challenge the status quo and work unsupervised.
• German CEFRL B2

Reference Nr.: 925185SBI
Role: Systems Engineer (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100%
Start: 01.10.2026
Duration: 1 year++
Deadline: 02.09.2026

If you are interested in this position, please send us your complete dossier. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

ITech Consult AG
+41417607701