Principal Design Quality Engineer
Core
Coordinates design control activities, risk management, and quality defect investigations for medical device projects from concept through release.
Role type
Principal Design Quality Engineer
Builds
Medical device products compliant with regulatory standards
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Experimental Design (DOE), Risk Management, Hazard Analysis, FMEA, Gage R&R studies, Statistical analysis, Technical report writing, Regulatory compliance interpretation
Preferred skills
ISO14971-2019 implementation, Design Control techniques, Human Factors/Usability Engineering, Post-market surveillance, Use Error Analysis
Technologies
Microsoft Office, Statistical software for DOE and R&R
Responsibilities
Coordinate investigations within manufacturing plants, Compose and execute verification and validation protocols, Investigate root causes via NCR/CAPA/MCH forms, Provide mentorship to junior staff, Manage testing and release procedures for finished products
Seniority
Senior, hands-on IC with strategic oversight
