R&D Engineer

Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA and ISO standards. Collaborate cross-functionally to execute verification and validation testing and manage product risk assessments. Requirements: Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry. Must have proven expertise in FDA design controls, risk management tools like FMEA, and proficiency in SolidWorks. 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 Regulatory Compliance 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