The Role
Own firmware verification for our implant and external devices, producing the evidence that proves our firmware is safe and ready for regulatory submission.
Responsibilities
Write and execute verification plans, protocols, and reports per IEC 62304 and FDA design controls.
Verify safety-critical behavior, including stimulation limits, fault handling, and wireless power/communication.
Maintain requirements-to-test traceability and support ISO 14971 risk management.
Lead defect triage and root-cause analysis; support audits and submissions.
Requirements
BS/MS in EE, CE, CS, or related field.
6+ years in embedded firmware verification, 3+ on regulated medical devices.
Proficiency in C and Python; hands-on lab instrument experience.
Working knowledge of IEC 62304, ISO 14971, and 21 CFR 820.
Nice to Have
Active implantable or neuromodulation experience.
Wireless power, BLE, or biosignal acquisition background.