Systems Engineer

ITech Consult AG; Risch-Rotkreuz; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

ITech Consult AG in Rotkreuz, Switzerland, is seeking a Systems Engineer (m/f/d) to join the NPC R&D BGE Systems Development and Integration team. You will define requirements, manage system architectures and collaborate across hardware, software, operations, and regulatory affairs to deliver robust BGE analysis systems.

The ideal candidate has 3–5 years in regulated development, a background in electronics, mechanics and software, and a proactive, structured working style.

Qualifikationen

• Background in development within a regulated environment, ideally in the IVD(R) area.
• 3–5 years of system definition and requirements engineering experience.
• Strong grasp of systems engineering methodologies across electronics, mechanics and software.
• English CEFR B2 level.
• Clear, structured working style and proactive collaboration.

Aufgaben

• Own requirements engineering and elicitation; manage requirements change control.
• Contribute to development documents and risk analysis; support verification activities.
• Collaborate during FMEA and risk assessments; assist design verification and validation.
• Facilitate interface management and cross-functional alignment; coordinate with HW/SW, Operations, Regulatory Affairs.
• Develop AI/MBSE concepts to improve systems engineering artifacts and processes; align components into one system.

Kenntnisse

Regulated environment

Systems engineering

Electronics

Mechanics

Software

Big picture thinking

Structured working style

Communication skills

Team collaboration

English B2

Ausbildung

BSc/MSc in Mechatronics or related

Tools

SysML

Enterprise Architect

Jobbeschreibung

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.

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

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.