The Senior Systems Engineer leads the definition, architecture, and validation of complex medical systems with a strong emphasis on usability-driven design
Job Summary
The Senior Systems Engineer leads the definition, architecture, and validation of complex medical systems with a strong emphasis on usability-driven design.
This role is accountable for ensuring that systems are safe, effective, and aligned with user needs, clinical workflows, and regulatory requirements.
The position requires deep expertise in risk management and regulatory compliance including IEC 62366, ISO 14971, FDA/MDR standards.
Matching Summary
The Senior Systems Engineer leads the definition, architecture, and validation of complex medical systems with a strong emphasis on usability-driven design.
Skills & Requirements
Must-have
Systems engineering methodologies
Usability and human factors engineering
Risk management and regulatory compliance
IEC 62366 ISO 14971 FDA MDR standards
Full lifecycle system development leadership
Nice-to-have
Influence across functions without direct authority
Continuous improvement of engineering methodologies
Cross-program alignment and governance
Key Requirements
Master's or PhD in Systems Engineering or related field
10+ years experience in regulated industries
5+ years experience in usability engineering
Fluency in English required
Work Rights
Must be located in Netherlands; not open for relocation