R&D Engineer

Job Description

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