Design Assurance Engineer III - Cardiology
Core
Ensures quality and compliance of medical device product development from concept through commercialization using design controls and verification.
Role type
Senior Design Assurance Engineer (Medical Devices)
Builds
Medical device products for the cardiology market
Domain
Medical Devices / Cardiology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DFMEA, Design Verification & Validation, Root Cause Analysis, statistical analysis, technical report writing, test protocol development, mechanical/electrical aptitude
Preferred skills
Process validation, post-market quality analysis, CAPA, ISO 13485/14971/FDA QSR compliance
Technologies
Microsoft Teams, Word, PowerPoint, Excel
Responsibilities
Apply systematic problem-solving methodologies to resolve quality issues; own deliverables related to Design Controls and Compliance; review and approve quality records including test protocols; interface with internal and external audit activities; develop and implement quality strategies.
Seniority
Senior, hands-on IC