Senior Design Quality Engineer / Ingénieur principal en qualité de la conception
Core
Lead design assurance efforts for a critical medical device in the Electrophysiology space, ensuring product safety, regulatory compliance, and design robustness across hardware, software, and system domains.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Capital Equipment (Electrophysiology systems)
Domain
Medical Devices / Electrophysiology
Required skills
Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820, ISO 13485), Root Cause Analysis, CAPA management, System Integration, Design Verification & Validation, Technical Authority, Cross-functional Leadership
Preferred skills
Mentoring junior engineers, Capital Equipment experience, Software quality standards (IEC 62304), Cardiac mapping systems experience, Agile methodologies
Technologies
ISO 14971, 21 CFR 820, ISO 13485, IEC 62304, FMEA, Hazard Analysis
Responsibilities
Lead design control activities including planning, risk management, verification, and validation; Maintain comprehensive risk management files (Hazard Analysis, FMEAs); Lead root cause investigations and resolution of test failures, CAPAs, and complaints; Provide mentorship to junior engineers on design assurance best practices; Act as primary point of contact for design assurance during audits and inspections; Collaborate with R&D, regulatory, manufacturing, and clinical teams on compliance matters.
Seniority
Senior, hands-on IC with mentorship responsibilities