Iec 62304 Jobs

Technical regulatory leader sought to author and drive FDA regulatory strategy and submissions for AI/ML-enabled SaMD at a fast‑moving digital health company.

Medtronic is hiring a Systems Integration Engineer II in Lafayette, CO to lead systems-level integration, verification, and validation for next-generation oximetry and wearable monitoring devices.

Lead SysML-based MBSE and requirements-driven software systems work for the Affera Mapping and Ablation System, defining interfaces, traceability, and verification for a cutting-edge cardiac electrophysiology product.

Experienced V&V engineer needed to lead verification and validation efforts for software-enabled medical devices, ensuring regulatory compliance and product quality across cross-functional teams.

Medtronic is hiring a Senior Engineering Program Manager (Quality Core Team Member) to lead quality strategy and design assurance for cardiac surgery product development in Brooklyn Park, MN.

Nextern is looking for a Senior Systems Engineer to lead system architecture, risk management, and verification/validation for electro-mechanical medical device projects.