Principal Engineer, Design Validation
Core
Define and scale design validation strategy for complex medical devices, specifically navigation and surgical robotics, ensuring compliance and clinical relevance.
Role type
Principal Design Validation Engineer
Builds
Complex hardware, software, and systems-based medical devices for clinical use
Domain
Medical Technology / Surgical Robotics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design validation strategy, User Needs translation, Validation study execution, Regulatory compliance (FDA/IEC), Statistical methodologies, Technical writing, Systems Engineering principles, Risk-based testing, Cross-functional leadership, Competitive landscape analysis
Preferred skills
Customer-centric Design, Accuracy Testing, Med tech development lifecycle, Technical documentation standards, Data interpretation, Analytical thinking
Technologies
FDA Guidance documents, IEC 62366, 60601-1-6, ANSI HE75
Responsibilities
Lead enterprise-level design validation strategy and execution frameworks; Develop robust user needs and intended use validation approaches; Define advanced, clinically relevant validation methods; Provide technical leadership for robotics-assisted orthopedic systems validation; Ensure adherence to US and EU regulatory requirements; Mentor teams in validation test methodologies.
Seniority
Principal, strategy & mentorship