The RoleYou'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/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
You 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 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
