Electrical Test Engineer - Medical Devices

Job Opportunity : Electrical Engineer

Location : Denver, CO

Client : Actalent

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 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:

o Leakage current testing

o Ground continuity testing

o Dielectric withstand (hipot) testing

o Insulation resistance testing

o 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.

Key Competencies

· Medical Device Design Controls

· Electrical Safety Testing

· Technical Documentation

· Risk Management

· Root Cause Analysis

· 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.