Hardware Engineer
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Job Summary
JD:
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(EMC) ISO 13485 (Quality Management Systems) FDA 21 CFR Part 820.30 (Design Controls)
Collaborate with manufacturing and supply chain teams for design transfer and production readiness.
Support DFM (Design for Manufacturability) and DFA (Design for Assembly) initiatives.
Proficient in hardware and simulation tools.
Maintain documentation including schematics BOMs test reports and change records.
Work closely with systems software mechanical and quality teams to ensure hardware meets system-level requirements.
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(EMC) ISO 13485 (Quality Management Systems) FDA 21 CFR Part 820.30 (Design Controls)
Collaborate with manufacturing and supply chain teams for design transfer and production readiness.
Support DFM (Design for Manufacturability) and DFA (Design for Assembly) initiatives.
Proficient in hardware and simulation tools.
Maintain documentation including schematics BOMs test reports and change records.
Work closely with systems software mechanical and quality teams to ensure hardware meets system-level requirements.
Key Skills
- Arm
- Electrical Engineering
- SOC
- System Design
- Firmware
- C/C++
- PCB
- Sensors
- Fpga
- Digital design
- Assembly
- Product Development
