Quality Engineer, Senior Staff/Principal (Risk Management)

Enchannel Medical•Irvine, CA

11h

About The Position

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. Position Overview The Quality Engineer (Risk Management) role will play a critical part in EnChannel’s transition from rapid development to formal FDA design controls. The position requires a hands-on Risk Management Subject Matter Expert (SME) to lead risk management remediation efforts, establish a compliant risk management framework, support the transfer of legacy design documentation from our China team, and align risk management processes with the FDA’s latest Quality Management System Regulation (QMSR) expectations, laying the groundwork for future ISO 14971 adoption, and ensuring the Design History File (DHF) is audited within the risk management domain.

Requirements

8-12 years (Senior Staff) OR 11-15 years (Principal) QE in Medical Device Quality or R&D with a specialization in risk management. Level to be determined during candidate screening process.
Demonstrated ownership of ISO 14971 based risk management for complex (Class II or III) devices with Software.
Hands-on experience creating or remediating risk frameworks, procedures and technical files.
Deep familiarity with FDA Design Controls, QSR/QMSR, and risk-based decision processes.
Experience supporting regulatory submissions or inspections where documentation involving documentation gaps.
Proven ability to work autonomously in a fast paced, dynamic environment.

Nice To Haves

Experience supporting global design transfers, especially between U.S. and China teams.
Knowledge of electrophysiology, catheter-based systems, or similar high-risk devices.

Responsibilities

Risk Management Framework Development & Remediation Establish a scalable, compliant risk management framework, including procedures, templates, and traceability structure.
Build the foundational infrastructure needed for future ISO 14971 adoption (full implementation not required but alignment is expected).
Lead remediation of existing risk management files to align with FDA’s updated QMSR expectations.
Conduct hazard identification, risk analysis, and risk control evaluation for Class III devices with Software.
Ensure full traceability across hazards, mitigations, design outputs, verification activities, and residual-risk assessments.
SME Support for Legacy Design Documentation (Transferred from China) Review, assess, and remediate transferred legacy risk documents.
Provide clear cross functional guidance on documentation adequacy, required updates, and compliance expectations.
Consolidate disparate or incomplete historical records into a coherent, audit ready risk management file.
Serve as the primary technical expert on risk management for Design, Quality, and Regulatory teams.
Design Controls Support Partner with R&D to translate legacy development work into compliant design inputs, outputs, and verification evidence.
Identify design documentation gaps that affect risk management integration.
Support DHF structure, change control, and documentation remediation to ensure consistency and compliance