EMC Compliance Engineer

Job Description and Responsibilities:

The EMC Compliance Engineer will own EMC compliance strategy, test planning, execution, debugging, and documentation across implantable electronics, surgical robotics, external wireless charging systems, and manufacturing. Responsibilities include: Work directly with hardware, firmware, mechanical, manufacturing, quality, and regulatory teams to identify EMC risks early in the design cycle, drive robust design mitigations (grounding, shielding, filtering, isolation, PCB layout and stackups), and support design reviews to imprint good EMC design practices. Own EMC and RF impact assessments for design changes within the medical device design control process; evaluate effects on emissions, immunity, wireless performance, and coexistence; determine re-test or analysis needs; and update risk assessments, protocols, and design documentation to maintain ongoing compliance. Develop and expand internal EMC test capabilities, including test setups, fixtures, measurement methods, equipment selection/qualification, and processes that enable rapid design iteration and reduce reliance on external laboratories. Own end-to-end EMC compliance strategy and plan/execute pre-compliance and formal EMC testing (conducted/radiated emissions, immunity, ESD, EFT, surge, voltage dips/interruptions, and wireless coexistence) for implantable electronics, surgical robotics, external wireless charging systems, and manufacturing line equipment, in accordance with IEC 60601-1-2, FCC Part 18, and related IEC 61000-series standards. Debug EMC failures at the bench and in test labs using oscilloscopes, spectrum analyzers, near-field probes, current probes, LISNs, VNAs, ESD guns, RF amplifiers, signal generators, data loggers, and custom fixtures; perform root cause analysis and recommend effective mitigations. Develop, execute, and maintain EMC test protocols, test reports, setup diagrams, deviations, engineering rationales, risk assessments, and requirement traceability for complex systems involving implants, chargers, and robots. Partner with external NRTL and EMC test laboratories (e.g., UL, TÜV, Intertek) for formal testing and certification; own interactions with regulatory bodies (e.g., FDA, notified bodies) regarding EMC and RF data, test strategies, and responses; and contribute EMC data and documentation to regulatory submissions (IDE, PMA, etc.). Own ESD control strategy for manufacturing lines, including workstation qualification, grounding verification, ionization, packaging, handling procedures, operator controls, equipment qualification, audits, and failure investigations aligned with ANSI/ESD S20.20. Build a culture of EMC-by-design: educate design teams, create design guidelines and review checklists, define EMC requirements and closure criteria, and integrate EMC considerations throughout the product development lifecycle. Stay current with advancements in EMC standards, medical device regulatory science, and related technologies; contribute to continuous improvement of compliance processes, SOPs, and knowledge sharing across teams.