Senior Systems Engineer (all genders) (full-time, regular)

📋 Description

• Lead holistic Systems Engineering in Design Controls for medical devices and combination products.
• Define system architecture, inputs, traceability, risk management, and DHF architecture.
• Coordinate testing activities and resource planning with cross-functional teams.
• Own key deliverables and drive stakeholder alignment across global projects.

🎯 Requirements

• Bachelor’s degree in Engineering/Science or related field with 7+ years (or Master’s with 5+ years).
• Technical leadership; compliant with safety and regulatory requirements.
• Experience in medical device/combination product development; familiarity with FDA 21 CFR 820.30
• Strong systems engineering: user needs, requirements, risk management, architecture, configuration
• Experience with DHF management and Design Control documents.
• Excellent written/oral communication in German and English; willingness to travel 10–20%.

🎁 Benefits

• Diverse work environment with real impact and open corporate culture.
• Attractive salary and onboarding with mentorship.
• Flexible work models and international career opportunities.
• Health management and company social benefits.