Design Assurance Engineer / Medical Devices (m/f/d)
Core
Ensuring quality and compliance for medical device design through verification, validation, and risk management.
Role type
Design Assurance Engineer (Medical Devices)
Builds
Medical devices and consumables for minimally invasive surgery (cameras, insufflators, pumps, tubing)
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control (GDP, MDR 2017/CFR820), Risk management (ISO 14971), FMEA, Design verification and validation, Quality planning, Failure analysis
Preferred skills
English fluency, German language skills
Technologies
None explicitly stated
Responsibilities
Create overall quality and VnV plans, Review design verification and validation specifications, Lead risk management and FMEA activities, Prepare test specifications for series testing, Analyze field returns and failures
Seniority
Mid-level, hands-on IC
