Senior Electrical Engineer
Position Summary
We are seeking a highly skilled Senior Electrical Engineer to design and develop complex electro-opto-mechanical systems for our next-generation corneal cross-linking system. This role requires strong technical expertise in circuit design, simulation, PCB development, and system integration, with a focus on compliance with medical device regulations.
Key Responsibilities
Execute detailed circuit design for analog, digital, mixed-signal, and power electronics.
Perform schematic capture, complex multi-layer PCB layout, and board bring-up testing.
Perform advanced circuit simulations, including DC, AC, transient, Monte Carlo, noise, signal integrity, power integrity, and EMC/EMI modeling.
Conduct worst-case, tolerance, and reliability analyses to anticipate failure modes and ensure long-term product robustness.
Drive thermal and power distribution modeling to inform PCB layout strategies.
Select, evaluate, and integrate off-the-shelf electrical components such as displays, power supplies, SBCs, motors, and sensors.
Develop and maintain detailed electrical wiring diagrams aligned with system-level architecture and direction from the engineering manager.
Manage CAD tools and ensure robust configuration management of the PCB design environment.
Manage and control the electronic component library, including symbols, footprints, 3D models, and component parameters.
Support prototype builds, board bring-up, debugging, and root-cause analysis of hardware issues.
Design and document PCBA and assembly test fixtures to support development and verification testing.
Collaborate closely with software and firmware teams to ensure successful hardware–firmware integration.
Define system level test protocols for system integration evaluation.
Define, document, and execute electrical design verification and validation protocols for assigned boards and subsystems.
Generate and maintain design documentation, test reports, and technical justifications in accordance with FDA design controls and QMS requirements.
Support sustaining engineering activities including ECO implementation, component obsolescence management, and CAPA investigations.
Provide technical support for manufacturing, supplier issues, and field feedback.
Support compliance engineering activities for product safety and EMC testing, including IEC 60601-1, IEC 60601-1-2, and other applicable standards.
Qualifications
Bachelor's or master's degree in electrical engineering or related field.
5+ years of progressive experience in electrical engineering, including complex PCB and system-level design.
Strong knowledge of analog, digital, mixed-signal, and power circuit design, validated by advanced circuit simulation, modeling, and analysis.
Hands-on experience with EDA and simulation tools, including PSpice, LTspice, MATLAB/Simulink, Altium Designer (preferred), Allegro PCB, and ORCAD.
Proven experience in signal integrity, power integrity, EMC/EMI, and thermal simulations for complex electronic systems.
Demonstrated experience defining and executing design verification and validation protocols under FDA design control requirements.
Working experience within a QMS/ISO13485.
Familiarity with IEC 60601-1, IEC 60601-1-2, and other applicable electrical safety and EMC standards.
Excellent analytical, problem-solving, and cross-functional collaboration skills.