Medical Device Electrical Engineer – IEC 60601-1 Expert

Pentangle Tech Services | P5 Group; Colorado; On-site; USD 90,000 - 120,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a Medical Electrical Engineer to design and support electrical systems for medical devices, and to perform IEC 60601-1 electrical safety testing.

You will document test results, support EU MDR 2017/745 compliance, prepare technical files, and collaborate with Quality, Regulatory, R&D, and Manufacturing teams.

The role requires strong troubleshooting and rigorous documentation to support audits, Notified Body reviews, and third-party testing.

Qualifications

• Bachelor's degree in Electrical Engineering or related field.
• 3+ years of medical device or highly regulated industry experience.
• Hands-on experience with IEC 60601-1.
• Knowledge of EU MDR 2017/745.
• Experience with electrical safety testing equipment.
• Knowledge of ISO 13485 and ISO 14971.
• Ability to read electrical schematics and technical specifications.
• Strong troubleshooting and documentation skills.

Responsibilities

• Design and support electrical systems for medical devices.
• Perform and document IEC 60601-1 electrical safety testing.
• Perform leakage current, ground continuity, hipot, insulation, and single-fault testing.
• Support EU MDR 2017/745 compliance and remediation activities.
• Prepare technical files, DHF, test reports, and verification documentation.
• Support IEC 60601-1-2 EMC testing.
• Work with Quality, Regulatory, R&D, and Manufacturing teams.
• Support audits, Notified Body reviews, and third-party testing.
• Troubleshoot product failures and help implement corrective actions.

Skills

Electrical Engineering degree

3+ years medical device experience

IEC 60601-1 experience

EU MDR 2017/745 knowledge

Electrical safety testing

ISO 13485 knowledge

ISO 14971 knowledge

Read electrical schematics

Troubleshooting & documentation

Education

Bachelor's degree in Electrical Engineering or related field

Job description

Pentangle Tech Services | P5 Group is seeking a Medical Electrical Engineer to design and support electrical systems for medical devices, and to perform IEC 60601-1 electrical safety testing.

You will document test results, support EU MDR 2017/745 compliance, prepare technical files, and collaborate with Quality, Regulatory, R&D, and Manufacturing teams.

The role requires strong troubleshooting and rigorous documentation to support audits, Notified Body reviews, and third-party testing.