Principal Design Assurance Engineer
Core
Lead Design Assurance activities and design verification for energy-based therapeutic medical devices treating hypertension, ensuring regulatory compliance and product safety throughout the development lifecycle.
Role type
Principal Design Assurance Engineer
Builds
Robust, safe, and reliable medical devices for the interventional cardiology therapy market
Domain
Medical device engineering / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control principles, risk management (ISO 14971), DFMEA/FMECA, design validation strategies, human factors strategies, regulatory compliance knowledge, project investigation leadership, mechanical design review support
Preferred skills
Test method development, Six Sigma principles, pre-clinical evaluations, statistical data analysis, project management, FDA 21 CFR Part 820 cGMP, ISO 13485
Technologies
ISO 14971, ISO 13485, FDA 21 CFR Part 820
Responsibilities
Lead Design Assurance activities across the full product cycle, own design verification activities and test strategies, liaise with R&D as SME for design validation and human factors, support design requirements flow down, partner with cross-functional teams for traceability, contribute to risk management activities, lead mechanical design support and reviews, identify and resolve reliability risks, maintain expert knowledge of regulatory compliance
Seniority
Principal, technical leadership & cross-functional partnership