Hardware 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 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.

Education & Skills preferred :