EU MDR Electrical Test Engineer for Medical Devices

Global Connect Technologies; Denver (CO); On-site; USD 85,000 - 120,000; Full time

Job summary

Global Connect Technologies seeks an experienced Electrical Engineer to support design, testing, and regulatory compliance of medical devices, focusing on EU MDR 2017/745 and IEC 60601 series. You will work with R&D, Quality, Regulatory Affairs, and Manufacturing to ensure safety, performance, and global readiness.

The role requires a Bachelor’s in Electrical Engineering, 3+ years in medical devices or regulated industry, hands-on testing, and strong documentation skills.

Qualifications

• Bachelor’s degree in Electrical Engineering or related field.
• Minimum 3 years in medical device development or regulated industry.
• Experience with EU MDR requirements and their impact on design and documentation.
• Hands-on testing and documentation to IEC 60601-1 standards.
• Familiarity with ISO 13485 quality systems.
• Knowledge of risk management under ISO 14971.

Responsibilities

• Design, develop, and evaluate electrical systems for medical devices.
• Support EU MDR remediation from concept to commercialization.
• Plan, execute, and document electrical testing per IEC 60601-1 and collateral standards.
• Conduct leakage current, ground continuity, hipot, insulation resistance, and single fault tests.
• Support MDR compliance activities and regulatory submissions.
• Prepare MDR Technical Files and Design History Files documentation.
• Collaborate with Regulatory Affairs and QA for audits and Notified Body reviews.
• Participate in risk management per ISO 14971.
• Interface with external test laboratories and certification bodies.
• Investigate failures and implement corrective actions.
• Generate test protocols and design verification reports.
• Support design reviews and ensure regulatory quality requirements.

Skills

Electrical Eng

Regulatory Compliance

Electrical Testing

EU MDR Knowledge

IEC 60601 Testing

Risk Management

Schematic Reading

Cross-functional

Education

Bachelor's degree in Electrical Engineering or related

Tools

IEC 60601 Test Equipment

EMC Lab Equipment

Lab Testing Environment

Job description

Global Connect Technologies seeks an experienced Electrical Engineer to support design, testing, and regulatory compliance of medical devices, focusing on EU MDR 2017/745 and IEC 60601 series. You will work with R&D, Quality, Regulatory Affairs, and Manufacturing to ensure safety, performance, and global readiness.

The role requires a Bachelor’s in Electrical Engineering, 3+ years in medical devices or regulated industry, hands-on testing, and strong documentation skills.