Medical Device Electrical Engineer: EU MDR & IEC 60601

Pentangle Tech Services | P5 Group; Denver (CO); On-site; USD 95,000 - 125,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Denver seeks an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. This role focuses on EU MDR remediation and IEC 60601-1 testing in a regulated environment.

You will collaborate with Regulatory Affairs and QA to maintain MDR and ISO 13485 compliance, and you will contribute to risk management per ISO 14971 while interfacing with labs and certification bodies.

Qualifications

• Bachelor's degree in Electrical Engineering or related field.
• Minimum 3 years in medical device development or highly regulated industry.
• Knowledge of EU MDR 2017/745 requirements.
• Hands-on testing and documentation to IEC 60601-1.
• Experience with electrical safety test equipment and labs.
• Understanding of design controls and ISO 13485.
• Knowledge of ISO 14971 risk management.
• Ability to interpret electrical schematics and specs.
• Strong troubleshooting and analytical skills.

Responsibilities

• Design, develop, and evaluate electrical systems for medical devices.
• Support EU MDR remediation activities.
• Plan, execute, and document electrical testing per IEC 60601-1.
• Perform electrical safety testing: leakage current, ground continuity, hipot, insulation resistance, single fault.
• Develop MDR Technical Files and Design History Files.
• Collaborate with Regulatory Affairs and QA teams.
• Participate in ISO 14971 risk management activities.
• Support EMC and electrical safety testing per IEC 60601-1-2.
• Interface with external labs and certification bodies.
• Investigate product failures and implement corrective actions.
• Generate engineering reports, protocols, validation docs, and DV reports.

Skills

Troubleshooting

Analytical skills

Regulatory compliance

Schematic interpretation

Testing experience

IEC 60601-1 testing

Education

Bachelor's degree in Electrical Engineering or related field

Tools

Electrical test equipment

Job description

Pentangle Tech Services | P5 Group in Denver seeks an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. This role focuses on EU MDR remediation and IEC 60601-1 testing in a regulated environment.

You will collaborate with Regulatory Affairs and QA to maintain MDR and ISO 13485 compliance, and you will contribute to risk management per ISO 14971 while interfacing with labs and certification bodies.