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About Our Client
Our client is a leading Medical Technology company based in Switzerland. It has a global network of production sites, subsidiaries, and sales partners.
Job Title: System Engineer
We are looking for a System Engineer to work 80-100% of their time on a permanent role located in Central Switzerland.
Key Responsibilities:
1. Maintain System Architecture: Collaborate with the project team to define and manage the system architecture of cutting-edge medical devices.
2. Define Product Requirements: Identify system components, define their interfaces, and ensure alignment with key factors like patient safety, customer requirements, functionality, reliability, testability, and cost-effectiveness.
3. Cross-Disciplinary Collaboration: Work closely with hardware, electronics, and embedded software development teams to ensure smooth integration across disciplines.
4. Regulatory Compliance: Ensure developed medical devices meet regulatory standards by planning and guiding integration and verification activities.
5. Risk Management: Participate in risk analysis according to ISO 14971, identifying, evaluating, and mitigating risks with specialist departments.
Requirements:
1. A technical or scientific degree (B.Sc., M.Sc., or equivalent).
2. Several years of experience in medical device development or regulated environments, with additional experience in software development considered beneficial.
3. Regulatory Knowledge: A solid understanding of regulatory requirements and the medical device development lifecycle.
4. Language Skills: Fluent written and spoken English and German.