Electrical Engineer

Job Title:

Electrical Engineer

Job Description

This role offers an opportunity for an experienced Electrical Engineer to contribute to the design, development, testing, and regulatory compliance of medical devices for global markets. You will focus on electrical systems and circuits for regulated medical products, ensuring they meet safety, performance, and regulatory requirements, with a strong emphasis on EU Medical Device Regulation (EU MDR 2017/745) and IEC series standards.

You will collaborate closely with cross-functional teams in R&D, Quality, Regulatory Affairs, and Manufacturing to deliver safe, compliant, and reliable medical devices.

Responsibilities

+ Design, develop, and evaluate electrical systems and circuits for medical devices, ensuring they meet performance, safety, and regulatory requirements.

+ Support EU MDR remediation activities from concept through commercialization, helping to align designs and documentation with regulatory expectations.

+ 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, and single fault condition evaluations.

+ Support compliance activities related to EU MDR (2017/745) requirements, ensuring electrical designs and documentation remain aligned with current regulations.

+ Develop and maintain technical documentation required for MDR Technical Files and Design History Files, ensuring traceability and completeness.

+ Collaborate with Regulatory Affairs and Quality Assurance teams to support regulatory submissions, audits, and Notified Body reviews.

+ Participate in risk management activities in accordance with ISO 14971, contributing to hazard analysis, risk assessment, and risk control documentation.

+ Support EMC and electrical safety testing in accordance with IEC 60601-1-2 and related standards, working to identify and mitigate electromagnetic compatibility issues.

+ Interface with external test laboratories and certification bodies during compliance testing and product certification efforts, ensuring timely and successful outcomes.

+ Investigate product failures, perform root cause analysis, and implement corrective and preventive actions to improve product reliability and safety.

+ Generate engineering reports, test protocols, validation documentation, and design verification reports to support design control and regulatory submissions.

+ Support design reviews and ensure compliance with applicable regulatory and quality system requirements throughout the product lifecycle.

Essential Skills

+ Bachelor's degree in Electrical Engineering or a related engineering discipline.

+ Minimum of 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 working with electrical safety test equipment and laboratory environments.

+ Understanding of design control requirements and quality systems, preferably in accordance with ISO 13485.

+ Knowledge of risk management processes under ISO 14971.

+ Ability to interpret electrical schematics, technical specifications, and test requirements accurately.

+ Strong problem-solving, analytical, and troubleshooting skills for complex electrical systems.

+ Excellent written and verbal communication skills, with the ability to document and present technical information clearly.

Additional

Skills & Qualifications

+

Experience with IEC 60601-1-2 electromagnetic compatibility (EMC) testing and compliance.

+ Experience supporting CE marking activities for medical devices.

+ Familiarity with FDA medical device regulations and global regulatory requirements.

+ Experience collaborating with cross-functional teams including R&D, Quality, Regulatory Affairs, and Manufacturing.

+ Prior involvement in preparing documentation for Technical Files and Design History Files.

+ Exposure to working with external test laboratories and certification bodies.

Work Environment

You will work in a laboratory and office environment focused on the development and testing of medical devices. The role involves frequent use of electrical safety test equipment and other laboratory instruments to perform testing such as leakage current, ground continuity, dielectric withstand (hipot), insulation resistance, and EMC evaluations in accordance with IEC 60601 series standards. You will collaborate closely with multidisciplinary teams in R&D, Quality, Regulatory Affairs, and Manufacturing, as well as interface with external test laboratories and certification bodies.

The work setting emphasizes adherence to formal design control processes, quality system requirements, and structured documentation practices to support global…