Mechanical Engineer (EU MDR)

Job Description

Lead research and development activities for medical devices to ensure compliance with EU MDR 2017/745 regulations. This includes generating technical documentation, conducting risk assessments, and managing verification and validation testing.

Requirements: Requires a degree in Mechanical, Biomedical, or Electrical engineering with several years of experience in regulated medical device R&D. Candidates must have demonstrated experience preparing EU MDR-compliant technical documentation and interacting with Notified Bodies.

Key Skills: EU MDR 2017/745, Design Controls, Technical Documentation, Risk Management, Verification and Validation, FMEA, ISO Standards, IEC Standards, SolidWorks, Windchill, CAPA, Root Cause Analysis, Notified Body Audits, GSPR, Design History Files, Medical Device R&D

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