Cardiovascular disease is the #1 cause of morbidity and mortality in the world. Much of this could be prevented with better access to specialist care. Take stroke as an example: any delay in treatment can lead to permanent disability or death. However, due to a lack of specialist surgeons, the most effective intervention can only be performed in 2% of US hospitals. For patients who present to one of the 98% of hospitals that do not offer the surgery, treatment is either significantly delayed or not offered at all because timely transfer is not feasible.
Our mission is to bring state-of-the-art vascular intervention to anyone, anytime, regardless of their location. Our team of medical clinicians, roboticists, and machine learning experts are working to bridge this gap by building the world’s first remotely-operated, semi-autonomous endovascular surgical robot.
We’ve already done what nobody else could—using our system, doctors from around the world were able to remotely perform this procedure from as far as 8000 miles away. We now need your help to bring this technology out of the laboratory and into hospitals everywhere.
You'll own the quality story for Remedy's surgical robot as it moves through design freeze, V&V, and IDE submission. This is a hands-on IC role: you'll author the documents, define the tests, and build the design history file — not just review what others produce. You'll work directly with engineering leads across software, mechanical, electrical, and ML to translate engineering work into audit-ready records.
This is a team-of-one role through IDE submission. You'll have support from Faiyaz and external regulatory consultants on the IDE narrative, but you'll own the quality content. Post-trial, we expect to build a small quality team underneath you.
Own IEC 62304 software lifecycle documentation across our software stack, including safety classification, architecture documentation, and unit/integration/system-level test records
Lead ISO 14971 risk management activities: hazard analysis, risk control documentation, residual risk evaluation
Define V&V test plans and protocols in collaboration with subsystem leads (SW, ML, mechanical, electrical, disposables)
Build and maintain requirements traceability from user needs through design inputs, outputs, and verification
Author the quality portions of the IDE submission package
Maintain the design history file as a living artifact, not an end-of-project scramble
Drive design control rigor across the team while keeping documentation proportional to risk
7+ years of hands-on quality work at a Class II or III medical device company
Direct experience preparing and submitting IDE, 510(k), or PMA documentation
Deep working knowledge of ISO 14971, IEC 62304, and ISO 13485
Comfort authoring technical documents that withstand FDA scrutiny
Experience working closely with engineering teams — you understand how engineers think and can translate between their work and quality records
Pragmatic judgment about how much rigor a given risk warrants
BS or MS in engineering, life sciences, or related field
Experience with software-heavy medical devices (especially safety-critical software)
Familiarity with IEC 62366 usability engineering and IEC 60601 electrical safety
Exposure to ISO 10993 biocompatibility or sterilization validation (ISO 11135 / 11137)
Cybersecurity documentation experience (FDA premarket guidance, IEC 81001-5-1)
Prior startup experience where you built quality systems from scratch or scaled them through a clinical milestone
Remedy Robotics exists to bring flawless, immediate, endovascular intervention (EI)—treatment for stroke, heart attack, bleeding, aneurysmal disease, pulmonary embolism and more— to every patient worldwide. Remedy is the only company in the world to have performed:
- Completely robotic neurointerventional procedures in humans from start to finish.
- Completely remote robotic neurointerventional procedures in humans from from start to finish.
- Autonomous endovascular navigation.
A few key principles underlie our work. We strongly believe that:
- EI is optimizable. Tool movements should be deliberate and efficient. Procedures should be fast and effective. Complications should be avoided without exception.
- All patients at elite US institutions deserve access to flawless EI without delay. But so do all patients at smaller US community hospitals. And so do all patients in Kinshasa and Port Moresby and Alice Springs and anywhere in the world.
- The world's finest technology and technologists should focus on advancing our health and wellbeing. They belong at Remedy Robotics.
