Job Description
Experienced Senior Electrical Hardware Design Engineer to perform design process from concept to production, ensuring innovative solutions meet the highest standards of safety, functionality, and
regulatory compliance.
Responsibilities
- Lead and execute the design and development of complex electrical hardware systems for medical devices, including schematic capture, PCB layout, component selection, and bill of materials.
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Conduct in-depth digital and analog electronic circuit design and integration, ensuring optimal functionality and adherence to design specifications.
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Develop and implement comprehensive test plans for verification and validation of hardware designs, including prototype bring-up, debugging, and compliance testing.
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Troubleshoot, modify, and rework electronic circuits to optimize performance and address any identified issues.
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Actively participate in the design control process, ensuring adherence to ISO 13485 quality management standards and regulatory requirements.
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Create and maintain detailed technical documentation, including schematics, layouts, and test reports.
- Collaborate effectively with internal teams (software, mechanical, quality) and external vendors to ensure seamless integration and project success.
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Stay up-to-date on the latest advancements in medical device technology and relevant regulatory standards.
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Other duties as assigned by management.
