R&D Engineer

Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA design controls. Collaborate with cross-functional teams to execute verification and validation testing and manage product risks through FMEA and fault-tree analysis. Requirements: Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with professional experience in medical device R&D. Must have a strong understanding of FDA requirements, ISO/IEC standards, and proficiency in SolidWorks and PLM systems. Key Skills: FDA Design Controls Medical Device Design Risk Management FMEA Verification and Validation Technical Writing SolidWorks Windchill ISO Standards IEC Standards CAPA Design History Files Fault-tree Analysis Product Lifecycle Management Engineering Studies Cross-functional Collaboration Benefits: Medical Dental Vision Critical Illness Accident Hospital 401(k) Retirement Plan Life Insurance Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Paid Time Off #J-18808-Ljbffr Actalent