Senior Electrical Engineer - Medical Device
Boston, Massachusetts
Full Time
$130k - $180k
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Lead the electrical design and development of Class II/III medical devices.
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Design analog, digital, and mixed-signal circuits for embedded systems, sensors, and power management.
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Own schematic capture and PCB layout using tools such as Altium or OrCAD.
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Perform circuit simulation, analysis, and bring-up of prototypes.
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Conduct design verification and validation in accordance with IEC 60601 and FDA standards.
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Support risk management and design failure modes analysis (DFMEA).
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Collaborate cross-functionally with mechanical, software, and quality teams.
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Participate in sustaining engineering and product improvement initiatives.
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Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and relevant standards.
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Bachelor’s or Master’s degree in Electrical Engineering or related field.
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7+ years of experience in electrical hardware development, preferably in a regulated medical device environment.
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Strong background in analog and digital circuit design, microcontrollers, sensors, and power supply systems.
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Experience with design tools such as Altium Designer, OrCAD, SPICE, etc.
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Familiarity with medical device standards (IEC 60601, ISO 14971, etc.).
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Knowledge of EMI/EMC design principles and compliance testing.
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Excellent problem-solving, documentation, and communication skills.
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Experience working within an FDA or ISO 13485-compliant quality system.
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Experience designing for manufacturability (DFM) and reliability (DFR).
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Experience with wireless technologies (BLE, Wi-Fi, NFC) and battery-powered systems.
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Prior involvement in successful submission of 510(k) or PMA applications.