Job Description
Job Requirements
About the Role
We are seeking a Hardware Architect to lead end-to-end architecture and development of medical device hardware platforms across multiple client programs. You will own system-level design decisions, safety and regulatory compliance strategy, and the technical roadmap from concept through design transfer to manufacturing. This role is ideal for a hands-on architect who can guide multidisciplinary teams (EE, FW & ME) to deliver safe, reliable, and manufacturable products under ISO 13485 design controls.
Key Responsibilities
About the Role
We are seeking a Hardware Architect to lead end-to-end architecture and development of medical device hardware platforms across multiple client programs. You will own system-level design decisions, safety and regulatory compliance strategy, and the technical roadmap from concept through design transfer to manufacturing. This role is ideal for a hands-on architect who can guide multidisciplinary teams (EE, FW & ME) to deliver safe, reliable, and manufacturable products under ISO 13485 design controls.
Key Responsibilities
- Define system and hardware architecture for medical devices.
- Translate user needs into hardware requirements and design specifications.
- Lead schematic design, PCB architecture, component selection, and power-management design.
- Ensure compliance with medical standards (IEC 60601-1, 60601-1-2, ISO 13485, ISO 14971).
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