Hardware Design Engineer

14 hours ago

Pune, Maharashtra, India Tata Elxsi Full time ₹ 8,00,000 - ₹ 12,00,000 per year

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 General Safety), IEC EMC), ISO Quality Management Systems), FDA 21 CFR Part 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:

  • MTech / ME / BE / BTech in Electrical Engineering, Electronics, Biomedical Engineering, or related field.
  • 5-8 years of experience in hardware design for medical devices
  • Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred.
  • Strong understanding of medical device lifecycle, design controls, and regulatory frameworks.
  • Familiarity with EMC testing, electrical safety standards, and component reliability analysis.
  • Certification in hardware design, medical electronics, or quality systems is desirable.

Strong analytical, documentation, and communication skills.

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