Medical Electrical Engineer - EU MDR/IEC 60601 Expert

Global Connect Technologies; Denver (CO); On-site; USD 90,000 - 140,000; Full time

Job summary

Global Connect Technologies in Denver is seeking an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. This role emphasizes EU MDR and IEC 60601 testing, collaborating with R&D, Quality, Regulatory Affairs, and Manufacturing to ensure safety and performance for global markets.

The ideal candidate holds a Bachelor's in Electrical Engineering with 3+ years in regulated environments, hands-on testing, risk management, and

Qualifications

• Bachelor's degree in Electrical Engineering or related field.
• 3+ years in medical device development or a highly regulated industry.
• Experience with EU MDR (2017/745) requirements and impact on design and documentation.
• Hands-on testing per IEC 60601-1 standards.
• Familiarity with ISO 13485 and ISO 14971.

Responsibilities

• Design, develop, evaluate electrical systems and circuits for medical devices.
• Support EU MDR remediation activities from concept through commercialization.
• Plan, execute, and document electrical testing in accordance with IEC 60601-1 and applicable standards.
• Conduct electrical safety testing: leakage current, ground continuity, hipot, insulation resistance, single fault evaluations.
• Support compliance activities related to EU MDR requirements.
• Develop and maintain MDR Technical Files and Design History Files.
• Collaborate with Regulatory Affairs and Quality Assurance for submissions, audits, and Notified Body reviews.
• Participate in risk management per ISO 14971.
• Support EMC and electrical safety testing per IEC 60601-1-2.
• Interface with external test labs and certification bodies.
• Investigate product failures and implement corrective actions.
• Generate engineering reports, test protocols, validation documentation, and design verification reports.
• Support design reviews and ensure regulatory and quality requirements.

Skills

Electrical engineering

Regulatory compliance

Electrical testing

Risk management ISO 14971

Schematic interpretation

Problem-solving

Communication skills

Education

Bachelor's degree in Electrical Engineering

Tools

IEC 60601 testing equipment

EMC testing equipment

Job description

Global Connect Technologies in Denver is seeking an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. This role emphasizes EU MDR and IEC 60601 testing, collaborating with R&D, Quality, Regulatory Affairs, and Manufacturing to ensure safety and performance for global markets.

The ideal candidate holds a Bachelor's in Electrical Engineering with 3+ years in regulated environments, hands-on testing, risk management, and