Systems Engineer (m/f/d) – System Development &Integration Vollzeit NEU

Jobdescription

Are you passionate about turning complex technologies into seamless, life-saving diagnostic solutions?

In critical care settings, every second counts. Blood gas and electrolyte (BGE) analysis provides clinicians with immediate, precise insights when patient outcomes depend on rapid decision-making. We are seeking a dedicated Systems Engineer (m/f/d) to join an international Near Patient Care R&D team in Rotkreuz. In this role, you will be the bridge where hardware, software, biochemical sensors, and reagents come together to form high-performance, highly reliable in-vitro diagnostic (IVD) systems.

If you thrive on solving multidisciplinary technical puzzles, mastering requirements engineering, and exploring modern approaches like Model-Based Systems Engineering (MBSE) and generative AI to refine development workflows, this is your opportunity to make a direct clinical impact across the full product lifecycle.

Important information:

Location: Rotkreuz, Switzerland

Start Date: October 1, 2026

Workload: 100%

Duration: 1 year (until end of 2027, extension likely)

Remote Work: Up to 20% home office

Travel: Minimal / Unlikely

Key Tasks & Responsibilities

• Requirements Management & Change Control: Own requirements engineering, elicitation, and management. Drive and coordinate the technical change control process from concept through lifecycle maintenance.

• Documentation & Traceability: Author and maintain core development artifacts, including technical and product requirements, traceability analyses for verification, configuration management, and product risk documentation.

• Risk Analysis & System Testing: Collaborate closely with interdisciplinary teams during Failure Mode and Effects Analysis (FMEA) and risk assessments. Support system testing during design verification and validation activities.

• Cross-Functional Interface Integration: Define and maintain technical interface descriptions to align internal teams, including Hardware/Software Engineering, Operations, Customer Support, Clinical Development, and Regulatory Affairs.

• Engineering Innovation (MBSE & AI): Explore and deploy LLM agents or AI tools to optimize documentation analysis and system performance. Drive component integration using MBSE methodologies.

What You Bring (Must-Haves)

• Regulated Industry Experience: Applied background in product development within a strictly regulated industry, ideally within the IVD or IVDR sector.

• Systems Engineering Expertise: 3 to 5 years of practical experience in system definition, requirements management, interface engineering, and end-to-end systems thinking.

• Cross-Domain Breadth: Strong technical understanding across multiple engineering disciplines (electronics, mechanics, and software).

• Methodology & Mindset: Solid grasp of systems engineering frameworks, work breakdown structures, and structured problem-solving.

• Communication & Collaboration: Highly organized, proactive team player with excellent stakeholder management skills and fluent English proficiency (CEFRL B2 minimum).

Desirable Skills (Nice-to-Haves)

• Experience combining AI tools or LLM agents with traditional systems engineering workflows.

• Hands-on experience with SysML and modeling tools such as Enterprise Architect.

• Professional credentials like INCOSE or IREB certifications.

• Degree (BSc/MSc) in Mechatronics, Biomedical Engineering, Electrical/Mechanical Engineering, Physics, or related technical disciplines.

• German language skills (CEFRL B2).

Verschlagwortet als: System Development & Integration, Systems Engineer