Principal Quality Design Assurance Engineer
Core
Senior Quality Engineering role defining, driving, and improving new product development, sustaining engineering, and post-market activities for a closed-loop neuromodulation platform.
Role type
Principal Design Assurance Engineer
Builds
Evoke® System (closed-loop neuromodulation platform for spinal cord stimulation)
Domain
Medical Devices / Neuromodulation / Regulatory Compliance
Deliverable
production ML models
Required skills
Design Control, Risk Management, ISO 13485, ISO 14971, 21 CFR 820, FDA QMSR, Verification & Validation Strategy, Regulatory Compliance, Quality System Development, Investigation Leadership, Strategic Planning
Preferred skills
Medical device firmware design assurance, Medical device software design assurance, Medical device cybersecurity
Technologies
ISO 13485, ISO 14971, 21 CFR 820, FDA QMSR
Responsibilities
Provide technical leadership for Design Assurance across product lifecycle; Lead risk management activities per ISO 14971; Review and approve Design and Development File deliverables; Mentor cross-functional teams on quality processes; Represent Quality with regulators and auditors; Drive continuous improvement in quality and compliance.
Seniority
Principal, strategic leadership & mentorship