Mechanical Engineer (EU MDR)

Lead the design, development, and compliance strategy for medical devices to ensure alignment with EU MDR 2017/745 regulations. This includes generating technical documentation, performing risk assessments, and coordinating with Notified Bodies for audits. Requirements: Requires a degree in Mechanical, Biomedical, or Electrical Engineering with several years of R&D experience in the medical device industry. Candidates must have demonstrated expertise in EU MDR technical documentation and design controls. Key Skills: EU MDR 2017/745 Design Controls Technical Documentation Risk Management FMEA Verification and Validation SolidWorks Windchill

ISO 14971

21 CFR 820.30

CAPA Notified Body Audits Technical File Maintenance GSPR Compliance Clinical Evaluation Post-Market Surveillance 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