Systems Engineer (m/f/d) – IVD(R) / Systems Engineering / Development / Regulated Environment
Join us in shaping the future of critical care diagnostics. Blood gas & electrolyte (BGE) analysis is essential in time-sensitive point-of-care settings, where both speed and quality are crucial. At NPC R&D BGE, we are committed to developing innovative BGE analysis systems and maintaining the lifecycle of existing products. Within NPC R&D, the System Development and Integration team combines the expertise of dedicated scientists, engineers, and lab technicians to ensure the seamless integration of hardware and software with sensor and reagent technologies, resulting in robust and reliable BGE analysis systems.
We are seeking a new team member for our Systems Engineering group to help drive the successful development of our complex diagnostic systems, which include fluidics, software, instruments, biochemical sensors, and reagents. In this role, you will manage system-level topics and documentation, focusing on requirements engineering, interface management, conceptual work, and change control management. You will also support the alignment and integration of various system components using Model-Based Systems Engineering and promote the application of agentic AI in requirements engineering.
The Perfect Candidate
The ideal candidate will have experience in development within a regulated environment, preferably in the IVD(R) sector, along with 3-5 years of practical experience in system definition, requirements engineering, and systems thinking. The candidate should possess:
- A strong grasp of systems engineering methodologies
- An understanding of multiple technology domains, including electronics, mechanics, and software
- A clear and structured working style
- Proactive collaboration skills
- The ability to maintain a big-picture perspective while paying 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 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 stakeholders across all systems engineering topics.
- Work cross-functionally with HW and SW Engineering, Operations, Customer Support, Clinical Development, Medical Affairs, and Regulatory Affairs.
- Collaborate on the definition, planning, and execution of project tasks and work packages.
Innovation: AI & Model-Based Systems Engineering (MBSE)
- Develop LLM agents or similar AI use cases for design, system performance, and documentation analysis to enhance systems engineering processes.
- Drive alignment between component development and overall system integration using MBSE methodologies.
Must Haves
- Experience in development within a regulated environment, ideally in the IVD(R) sector
- Minimum 3-5 years of practical experience in system definition and requirements engineering
- Fundamental knowledge of systems engineering methodologies
- Experience in multiple technology domains (e.g., Electronics, Mechanics, Software)
- Excellent communication skills and a clear working style
- Proactive mindset that fosters collaboration within interdisciplinary teams
- Analytical thinking with a focus on both the big picture and the details
- Pragmatic approach to problem-solving
- Strong team player
- Advanced English proficiency (CEFRL B2)
Nice to Haves
- Experience integrating systems engineering with artificial intelligence
- INCOSE or IREB certification
- Practical experience with SysML or Enterprise Architect
- Experience in system integration of complex multidisciplinary systems
- Bachelor's or Master's degree (BSc/MSc) in Mechatronics, Mechanical/Electrical Engineering, Physics, Biomedical Engineering, Biotechnology, Natural Sciences, or equivalent
- Ability to challenge the status quo and work independently
- German proficiency (CEFRL B2)
Reference No.: 925185SBI
Role: Systems Engineer (m/f/d)
Industry: Pharma
Workplace: Rotkreuz
Full-time: 100%
Start Date: October 1, 2026
Duration: 1 year++
Application Deadline: September 2, 2026
If you are interested in this position, please apply online using the form below. Only applications matching the job profile will be considered.
About Us
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland specializing in the placement of highly qualified candidates in the fields of IT, Life Science, and Engineering. We also offer staff leasing and payroll services free of charge for our candidates; we do not impose any additional fees for Payroll services.
For more information about our company, open positions, or our attractive Payroll-Only program, please contact us at +41 41 760 77 01.