Sr Design Quality Engineer
Core
Ensures product quality, reliability, and regulatory compliance for medical devices through design controls, risk management, and cross-functional leadership.
Role type
Senior Design Quality Engineer
Builds
Medical device products (Acute Care & Monitoring portfolio)
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Risk management (ISO 14971), Verification and validation planning, CAPA and root cause analysis, Failure analysis, Electronic hardware systems knowledge (PCB, schematics), Quality Management Systems (ISO 13485, FDA 21 CFR 820, EU MDR), Design for Six Sigma (DFSS), Cross-functional project leadership
Preferred skills
Statistical methods (ANOVA, GR&R), Statistical software (Minitab), Reliability testing (HALT/HASS), Lean Six Sigma Green/Black Belt, DFSS methodologies
Technologies
ISO 13485, FDA 21 CFR 820, EU MDR, ISO 14971, IEC 60601, Minitab, PCB design tools
Responsibilities
Review new and modified product designs for safety and compliance, Lead development of risk management documentation, Support verification and validation strategies, Provide quality engineering support for sustaining engineering initiatives, Collaborate with R&D and Regulatory teams on product changes, Drive continuous improvement initiatives, Mentor engineers on quality principles
Seniority
Senior, hands-on IC