Mechanical Engineer

Job Description

Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA design controls. Collaborate cross-functionally 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 R&D experience in the medical device industry. Must have a strong understanding of FDA design controls, ISO/IEC standards, and proficiency in SolidWorks and PLM systems.

Key Skills: FDA Design Controls, Medical Device Design, Risk Management, FMEA, Fault-Tree Analysis, Verification and Validation, Technical Writing, SolidWorks, Windchill, CAPA, ISO Standards, IEC Standards, Design History Files, 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