Senior Electrical Engineer – Medical Devices

Job Summary: We are seeking a highly skilled and experienced Electrical Engineer to join our Medical Device R&D team. The ideal candidate will have a strong background in hardware development and a comprehensive understanding of the entire product lifecycle—from requirements analysis to obsolescence management. This role involves working cross-functionally with design, compliance, testing, and manufacturing teams to deliver safe, effective, and innovative medical devices. Key Responsibilities: Requirement Analysis: Collaborate with cross-functional teams to gather and analyze electrical requirements for medical devices. Planning & Architecture: Develop hardware architecture and design plans aligned with regulatory and performance requirements. Design & Development: Design analog and digital circuits, PCB layouts, and embedded systems for medical devices. Perform schematic capture, simulation, and design reviews. Compliance & Regulatory: Ensure designs meet relevant medical standards (e.g., IEC 60601, ISO 13485, FDA, CE). Support risk management and documentation for regulatory submissions. Testing & Validation: Develop and execute verification and validation protocols. Conduct EMC, safety, and reliability testing. Costing & BOM Management: Optimize design for cost, manufacturability, and supply chain efficiency. Prepare and manage Bill of Materials (BOM). Lifecycle & Obsolescence Management: Monitor component availability and plan for end-of-life scenarios. Support redesigns and updates for legacy products. Qualifications: Bachelor’s or Master’s degree in Electrical Engineering or related field. 6–10 years of experience in hardware development, preferably in medical devices. Strong knowledge of analog/digital circuit design, embedded systems, and PCB development. Familiarity with medical device standards and regulatory requirements. Experience with tools like Altium, OrCAD, SPICE, MATLAB, LabVIEW, etc. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Experience with wireless communication (Bluetooth, Wi-Fi) and power management. Knowledge of cybersecurity in medical devices. Exposure to design for manufacturability (DFM) and design for testability (DFT). Familiarity with Agile or Stage-Gate development processes.

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