Quality Engineer
Remedy Robotics https://www.remedyrobotics.com/ is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.
We are looking to hire a Quality Engineer for our Hardware Team.
What You’ll Do:
- Own the quality narrative for Remedy’s surgical robot across design freeze, V&V, and IDE submission
- Operate as a hands-on individual contributor, authoring core quality and regulatory documentation
- Define and execute verification and validation (V&V) strategies, including plans, protocols, and test requirements across subsystem leads (software, ML, mechanical, electrical, and disposables)
- Own IEC 62304 software lifecycle documentation across the full software stack, including safety classification, architecture documentation, and unit, integration, and system-level test evidence
- Lead ISO 14971 risk management activities, including hazard analysis, risk control definition and implementation, and residual risk evaluation
- Establish and maintain end-to-end requirements traceability from user needs through design inputs, outputs, and verification activities
- Author the quality and design control sections of the IDE submission package
- Build and maintain the Design History File (DHF) as a continuously updated, audit-ready system of record
- Collaborate closely with software, mechanical, electrical, and ML engineering leads to ensur...