EMI/EMC Test Engineer

SAPSOL Technologies Inc.; Glasgow (AL); On-site; USD 90,000 - 140,000; Full time

Job summary

SAPSOL Technologies Inc. seeks an EMI/EMC Test Engineer to own electromagnetic compatibility and interference testing for our medical device portfolio, ensuring compliance with IEC 60601-1-2 and supporting FDA/international regulatory submissions.

Work with R&D, systems engineering, and regulatory affairs to identify EMC risks throughout the design lifecycle. You will plan and execute EMC testing, review designs for isolation barriers, and coordinate with labs to obtain formal certifications

Qualifications

• Bachelor's degree in Electrical/Biomedical Engineering or related field.
• 3-7 years of EMI/EMC experience, with at least 2+ years in medical devices.
• Working knowledge of IEC 60601-1-2 and IEC 61000-4 series for medical devices.
• Understanding of essential performance and basic safety in EMC context.
• Experience with EMC test equipment (receivers, analyzers, ESD, surge generators).
• Ability to read schematics/PCB layouts, especially isolation barriers and patient-connected parts.
• Strong technical writing skills for regulatory documentation.

Responsibilities

• Plan, execute, and analyze EMC pre-compliance and full-compliance testing per IEC 60601-1-2.
• Apply collateral/particular standards (e.g., home healthcare IEC 60601-1-11).
• Support wireless coexistence testing for connected medical devices (BLE, Wi-Fi).
• Conduct EMC design reviews at schematic/PCB/harness/enclosure stages.
• Debug EMC failures with test equipment and probes.
• Coordinate with third-party labs for IEC 60601-1-2 certification testing.
• Author and maintain EMC test plans, protocols, and FDA/CE submission documents.
• Link EMC test results to ISO 14971 risk management.

Skills

EMC testing

Regulatory awareness

Technical writing

Education

Bachelor's degree in Electrical/Biomedical Engineering

Tools

EMI receivers

Spectrum analyzers

ESD guns

Surge/EFT/burst generators

Near-field probes

Job description

No of Position:01

Job Summary

We are seeking an EMI/EMC Test Engineer to own electromagnetic compatibility and electromagnetic interference testing for our medical device portfolio, ensuring compliance with IEC 60601-1-2 and supporting FDA/international regulatory submissions. The role works closely with R&D, systems engineering, and regulatory affairs to identify and mitigate EMC risks throughout the design lifecycle, particularly for devices operating in clinical and home-use environments.

Required Qualifications

• Bachelor's degree in Electrical/Biomedical Engineering or related field
• 3-7 years of EMI/EMC experience, with at least 2+ years specific to medical devices
• Working knowledge of IEC 60601-1-2 and its test methods (IEC 61000-4 series as applied to medical devices)
• Understanding of \"essential performance\" and \"basic safety\" concepts as they relate to EMC pass/fail criteria
• Experience with EMC test equipment: EMI receivers, spectrum analyzers, ESD guns, surge/EFT/burst generators, near-field probes
• Ability to read schematics/PCB layouts, particularly isolation barriers and patient-applied parts
• Strong technical writing skills for regulatory-grade documentation

Key Responsibilities

• Plan, execute, and analyze EMC pre-compliance and full-compliance testing per IEC 60601-1-2 (radiated/conducted emissions, radiated/conducted immunity, ESD, EFT/burst, surge, magnetic field immunity, dips & interruptions)
• Apply collateral/particular standards as applicable (e.g., IEC 60601-1-11 for home healthcare environments, IEC 60601-2-XX device-specific standards)
• Support wireless coexistence testing for connected medical devices (BLE, Wi-Fi) per FDA guidance on RF wireless technology
• Conduct EMC design reviews at schematic, PCB layout, cable/harness, and enclosure stages - especially around patient-connected circuits and isolation boundaries
• Debug EMI/EMC failures using spectrum analyzers, EMI receivers, near-field probes, ESD simulators, and surge/EFT generators
• Coordinate with accredited third-party test labs (e.g., UL, TÜV, Intertek) for formal IEC 60601-1-2 certification testing
• Author and maintain EMC test plans, protocols, and reports suitable for FDA 510(k)/PMA submissions and CE technical files (MDR)
• Link EMC test results to risk management file (ISO 14971) - document hazards, mitigations, and residual risk related to electromagnetic disturbances
• Recommend and validate design mitigations (shielding, filtering, grounding, isolation) - without compromising patient safety or essential performance
• Support root-cause investigation for field complaints or CAPAs related to EMC issues
• Maintain traceability between EMC test evidence and Design History File (DHF) per IEC 62304/design control requirements
• Track evolving global regulatory requirements (FDA, EU MDR, Health Canada, etc.) affecting EMC for medical devices