Mechanical Engineer (EU MDR)

Job Description

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