Remedy Robotics

Medical Device

QualityEngineer

San Francisco, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Quality Engineer at Remedy Robotics. Skills: Quality Assurance for Class II/III Medical Devices, IDE/510(k)/PMA Documentation, ISO 14971, IEC 62304, ISO 13485. Own the quality story for Remedy's surgical robot through design freeze, V&V, and IDE submission. Author documents, define tests, and build the design history file”

What You'll Achieve.

Bring technology out of the laboratory and into hospitals everywhere; Successful IDE submission

Industry & Context.

Medical Device

What They're Looking For.

Must Have

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 Have

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

What You'll Do.

Own the quality story for Remedy's surgical robot through design freeze

and build the design history file

Work directly with engineering leads across software

and ML to translate engineering work into audit-ready records

Own the quality content for IDE submission

Own IEC 62304 software lifecycle documentation

Lead ISO 14971 risk management activities

Define V&V test plans and protocols

Build and maintain requirements traceability

Author the quality portions of the IDE submission package

Maintain the design history file

Drive design control rigor across the team

How You'll Work.

Team & Collaboration

Work directly with engineering leads across software, mechanical, electrical, and ML; Collaborate with subsystem leads (SW, ML, mechanical, electrical, disposables) on V&V test plans and protocols; Translate engineering work into audit-ready records

Communication Scope

Translate between engineering work and quality records

Full Job Description

ABOUT REMEDY ROBOTICS 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. YOU WILL - Own IEC 62304 software lifecycle documentation across our software stack, including safety classification, architecture documentation, and unit/integration/syste

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