Design Quality Engineer (m/w/d)
Core
Design Quality Engineer ensuring system-level quality for medical devices and digital health solutions, focusing on risk management, regulatory compliance, and process improvement.
Role type
Senior IC Design Quality Engineer (Medical Devices)
Builds
Medical devices, digital health solutions, and therapies for clinical teams and patients
Domain
Healthcare / Medical Devices / Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems Engineering, Electronic development, Product lifecycle management, Quality methods (dFMEA, System-FMEA), Risk management, Regulatory compliance knowledge, Process improvement, Stakeholder communication
Preferred skills
ISO 13485, ISO 14971, IEC 60601 standards knowledge, Tool application for FMEA
Technologies
FMEA tools, Electronic design tools, Quality management systems
Responsibilities
Advise on system-level quality assurance including integration and interface testing, Evaluate modern methods for system and electronic quality, Define and monitor quality metrics, Create project-specific quality strategies, Support error and non-conformance management, Plan and moderate Design-FMEAs for electronic and mechatronic subsystems, Improve product lifecycle processes for regulatory compliance
Seniority
Senior, hands-on IC