Quality Engineer

Remedy Robotics • San Francisco, CA

22d

About The Position

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.
The Role
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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior