Best suited to mid-level quality engineers with medical device experience who thrive in hands-on regulatory documentation roles within a robotics-focused startup environment.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Remedyrobotics via Ashby
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 ensure development work is translated into compliant, audit-ready records
- Drive design control rigor across the organization while ensuring documentation is appropriately scaled to product risk and regulatory context
Minimum Qualifications:
- 7+ years of hands-on quality experience within a Class II or Class III medical device environment
- Direct experience supporting the preparation and submission of IDE, 510(k), and/or PMA documentation
- Strong working knowledge of ISO 14971, IEC 62304, and ISO 13485 standards
- Proven ability to author technical documentation that withstands regulatory (FDA) review and scrutiny
- Experience collaborating closely with engineering teams, with the ability to translate engineering work into compliant quality and regulatory records
- Sound, risk-based judgment in applying appropriate levels of rigor to varying product and patient safety risks
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
Preferred Qualifications:
- Experience with software-intensive medical devices, particularly safety-critical software systems
- Familiarity with IEC 62366 usability engineering and IEC 60601 electrical safety standards
- Exposure to biocompatibility and sterilization validation standards, including ISO 10993, ISO 11135, and ISO 11137
- Experience with medical device cybersecurity documentation in accordance with FDA guidance and IEC 81001-5-1
- Prior startup experience, including building quality systems from the ground up or scaling them through key clinical development milestones
Source: Remedyrobotics careers (Ashby)