
Senior Electrical Engineer – Medical Devices
3 days ago
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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