Electrical Test Engineer - 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

We are seeking an experienced Electrical Engineer to support the design, development, testing, and regulatory compliance of medical devices. The ideal candidate will have a strong background in electrical engineering for regulated medical products, with direct experience supporting EU Medical Device Regulation (EU MDR 2017/745) compliance and performing/testing against IEC 60601 series standards. This role will work closely with R&D, Quality, Regulatory Affairs, and Manufacturing teams to ensure products meet safety, performance, and regulatory requirements for global markets.

Key Responsibilities

• Design, develop, and 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 collateral and particular standards.
• Conduct electrical safety testing, including:
  • Leakage current testing
  • Ground continuity testing
  • Dielectric withstand (hipot) testing
  • Insulation resistance testing
  • Single fault condition evaluations
• Support compliance activities related to EU MDR (2017/745) requirements.
• Develop and maintain technical documentation required for MDR Technical Files and Design History Files.
• Collaborate with Regulatory Affairs and Quality Assurance teams to support submissions, audits, and Notified Body reviews.
• Participate in risk management activities in accordance with ISO 14971.
• Support EMC and electrical safety testing per IEC 60601-1-2 and related standards.
• Interface with external test laboratories and certification bodies during compliance testing and product certification efforts.
• Investigate product failures and implement corrective actions.
• Generate engineering reports, test protocols, validation documentation, and design verification reports.
• Support design reviews and ensure compliance with applicable regulatory and quality requirements.

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.
• Demonstrated knowledge of EU MDR (2017/745) requirements and their impact on medical device design and documentation.
• Hands‑on experience conducting and documenting testing to IEC 60601-1 standards.
• Experience with electrical safety test equipment and laboratory environments.
• Understanding of design control requirements and quality systems, preferably ISO 13485.
• Knowledge of risk management processes under ISO 14971.
• Ability to interpret electrical schematics, technical specifications, and test requirements.
• Strong problem‑solving, analytical, and troubleshooting skills.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience with IEC 60601-1-2 (EMC) testing and compliance.
• Experience supporting CE marking activities for medical devices.
• Familiarity with FDA medical device regulations and global regulatory requirements.
• Experience with verification and validation testing methodologies.
• Knowledge of embedded systems, power electronics, or medical device software integration.
• Prior experience working directly with Notified Bodies and third‑party test laboratories.
• Medical Device Design Controls
• Electrical Safety Testing
• Technical Documentation
• Cross‑Functional Collaboration

This role is ideal for an electrical engineer who can bridge product development and regulatory compliance while ensuring medical devices meet the stringent requirements of EU MDR and IEC 60601 standards.