About this opportunity
Pentangle Tech Services | P5 Group lists this Electrical Engineer opportunity in denver, Colorado. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Summary
We are seeking an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. The ideal candidate will have experience supporting EU Medical Device Regulation (EU MDR 2017/745) compliance and testing against IEC 60601 series standards.
Key Responsibilities
Design, develop, and evaluate electrical systems and circuits for medical devices.
Support EU MDR remediation activities.
Plan, execute, and document electrical testing according to IEC 60601-1.
Perform electrical safety testing, including:
Leakage current
Ground continuity
Dielectric withstand / Hipot
Insulation resistance
Single fault condition evaluations
Support EU MDR compliance activities.
Develop and maintain MDR Technical Files and Design History Files.
Collaborate with Regulatory Affairs and Quality Assurance teams.
Participate in ISO 14971 risk management activities.
Support EMC and electrical safety testing per IEC 60601-1-2.
Interface with external test laboratories and certification bodies.
Investigate product failures and implement corrective actions.
Generate engineering reports, test protocols, validation documentation, and design verification reports.
Required Qualifications
Bachelor's degree in Electrical Engineering or related engineering discipline.
Minimum 3 years of experience in medical device development or a highly regulated industry.
Knowledge of EU MDR 2017/745 requirements.
Hands-on experience conducting and documenting testing to IEC 60601-1 .
Experience with electrical safety test equipment and laboratory environments.
Understanding of design controls and quality systems, preferably ISO 13485 .
Knowledge of ISO 14971 risk management.
Ability to interpret electrical schematics, technical specifications, and test requirements.
Strong troubleshooting and analytical skills.
Preferred Qualifications
IEC 60601-1-2 / EMC testing
CE marking activities
FDA medical device regulations
Verification & validation testing
Embedded systems, power electronics, or medical device software integration
Experience with Notified Bodies and third-party test laboratories
Worksite address
denver, CO, 80285, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.