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
Skills Required
- Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field
- 3-7 years of EMI/EMC experience
- At least 2 years of EMI/EMC experience specific to medical devices
- Working knowledge of IEC 60601-1-2 and IEC 61000-4 test methods as applied to medical devices
- Understanding of essential performance and basic safety concepts for EMC pass/fail criteria
- Experience using EMI receivers, spectrum analyzers, ESD guns, surge/EFT/burst generators, and near-field probes
- Ability to read schematics and PCB layouts, including isolation barriers and patient-applied parts
- Strong technical writing skills for regulatory-grade documentation
What We Do
We started the organization with a vision of some of the top technology professionals in the industry to carve a niche for the next generation solutions as well provide that breeze of fresh air in emerging technology which will help our client think out of the box and provide rapid go to market solutions . The complex technology solutions and global multilingual programs roll out have been hall mark of success for our team. Our key team members are all hands on professional who have the vision and experience of having grown and developed the business from scratch. The have been the guiding power and light behind taking the company to the next level. The management of the organization has an average of over 20 years of experience in starting and running IT companies in the J2EE segment and ERP segment in North America , Australia , EMEA and Europe. The management actively guides the company to make strategic decisions and move forward and make the right decisions . We provide path breaking solutions and consultants who will fit, meet and exceed your requirements. Our focus is primarily in SAP, Oracle, IBM and MS technologies with expertise in technology verticals like cloud, big data and mobility. SAPSOL Technologies Inc . is currently funded by private investment from our management and some external investors. We are open to innovative proposals as well as funding the next generation of solutions for other start-up companies who have a great idea but are unable to leverage
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