Senior Design Quality Assurance Engineer - Neuromodulation (NALU)
Core
Senior Design Quality Assurance Engineer ensuring quality for neuromodulation medical-device systems, specifically external equipment, implantable leads, accessories, and surgical tools.
Role type
Senior IC Design Quality Assurance Engineer
Builds
Implantable leads, accessories, and surgical tools for neuromodulation systems
Domain
Medical devices / Neuromodulation
Required skills
Design controls, Risk management, Design verification and validation, Design transfer, Change assessment, Post-market feedback, Biocompatibility, Sterilization, Packaging, Shelf-life, Transport, Electrical safety, Electromagnetic compatibility, Supplier quality, Manufacturing quality, CAPA, Complaint investigations, Field-signal evaluations
Preferred skills
Human factors, Regulatory affairs, Clinical collaboration
Technologies
None stated
Responsibilities
Serve as Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects; Support cross-functional teams through design-control activities; Provide quality oversight for risk-management activities; Support design validation and human-factors activities; Provide quality oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, and electromagnetic compatibility; Support supplier and manufacturing quality activities; Lead or support design-change assessments, CAPA, complaint investigations, and field-signal evaluations.
Seniority
Senior, hands-on IC