Hardware Design Engineer

Roles and Responsibilities:

• Design and develop analog and digital hardware components for electromechanical medical devices.

• Create schematics, PCB layouts, and hardware architecture in compliance with product requirements.

• Select and qualify components considering performance, reliability, and regulatory constraints.

• Collaborate with mechanical and software teams to ensure seamless system integration.

• Develop and execute hardware verification plans including functional, electrical safety, EMC, and

environmental testing.

• Support design verification and validation activities in alignment with IEC 60601 and ISO 80601

standards.

• Troubleshoot and debug hardware issues during development and testing phases.

• Document test procedures, results, and compliance evidence for regulatory submissions.

• Ensure hardware design complies with - IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), ISO

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