Quality Engineer

Responsibilities

• Own the quality narrative for Remedy’s surgical robot across design freeze, V&V, and IDE submission
• Author core quality and regulatory documentation as a hands-on individual contributor
• Define and execute verification and validation (V&V) strategies across software, ML, mechanical, electrical, and disposables
• Manage IEC 62304 software lifecycle documentation, including safety classification and test evidence
• Lead ISO 14971 risk management activities, including hazard analysis and risk control
• Establish end-to-end requirements traceability from user needs to verification activities
• Author quality and design control sections for IDE submission packages
• Build and maintain the Design History File (DHF) as an audit-ready system of record
• Collaborate with engineering leads to ensure development work is translated into compliant records
• Drive design control rigor scaled to product risk and regulatory context

Requirements

• 7+ years of hands-on quality experience in Class II or Class III medical device environments
• Direct experience supporting IDE, 510(k), or PMA documentation submissions
• Strong working knowledge of ISO 14971, IEC 62304, and ISO 13485 standards
• Proven ability to author technical documentation for FDA review
• Experience collaborating with engineering teams to create compliant records
• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field

Preferred Qualifications

• Experience with software-intensive, safety-critical medical devices
• Familiarity with IEC 62366 usability and IEC 60601 electrical safety standards
• Exposure to biocompatibility and sterilization validation (ISO 10993, ISO 11135, ISO 11137)
• Experience with medical device cybersecurity documentation (IEC 81001-5-1)
• Prior startup experience building or scaling quality systems

About the Company

Remedy Robotics 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.