Senior Design Quality Engineer - Electrophysiology
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 control management, Risk management (FMEA, Hazard Analysis), Design verification and validation, Root cause analysis, CAPA management, Regulatory compliance (ISO 13485, FDA), System integration, Technical authority in Quality, Mentorship
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead design control activities including planning, risk management, verification, and validation; Own and maintain comprehensive risk management files; Lead root cause investigations and resolution of test failures and complaints; Act as primary point of contact for design assurance during audits and regulatory inspections; Provide mentorship to junior engineers on design assurance best practices.
Seniority
Senior, hands-on IC with mentorship responsibilities