Job Description
Staff Electrical Engineer - Contract-to-Hire - Trumbull, CT, United States (On-site)
Job Description
Edison Smart are supporting a major medical device organisation who are searching for a Senior Electrical Engineer to join their team. This is an opportunity to work on innovative medical technologies that directly impact patient care, with a focus on sustaining engineering, root cause analysis, and ensuring compliance with regulatory standards.
Responsibilities
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Lead cross-functional teams including operations, supply chain, regulatory, and quality to deliver change control projects on time.
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Design and develop electrical systems and components, including schematics, wiring diagrams, and PCB layouts.
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Write, execute, and report on design verification studies.
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Create and update Design Control documentation including design inputs, outputs, and traceability matrix.
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Conduct feasibility studies and provide technical support for both new and existing products.
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Perform and document root cause analysis of complaints/NCs/CAPAs for advanced electromechanical medical devices.
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Drive product compliance projects in line with IEC 60601 and other regulatory standards.
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Participate in design reviews and provide constructive feedback.
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Stay current with industry trends and advancements in medical device electrical design.
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On-site role with flexibility as required by the business.
Qualifications
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Minimum of 4 years’ experience in electrical design for medical devices.
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Strong background in design for EMC and electrical safety (IEC 60601-1-2, IEC 60601-1).
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Experience troubleshooting and executing design changes for complex electromechanical devices.
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Bachelor’s degree or higher in Electrical Engineering or related field.
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Strong knowledge of analog/digital circuits, power electronics, and control systems.
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Proficiency with PCB design and simulation tools (e.g., Altium Designer, MATLAB).
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Familiarity with design controls, risk management, and verification/validation processes.
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Experience with regulatory standards (IEC 60601, FDA 820.11, MDR, ISO 13485).
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Strong problem-solving, analytical, and communication skills.
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Skilled in technical report and protocol writing.
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Proficient with test/measurement equipment (oscilloscopes, logic analyzers, emulators/debuggers).
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Ability to manage multiple projects in a fast-paced environment.