Job Requirements
About the Role
We are seeking a Hardware Architect to lead end-to-end architecture and development of medical device hardware platforms across multiple client programs. You will own system-level design decisions, safety and regulatory compliance strategy, and the technical roadmap from concept through design transfer to manufacturing. This role is ideal for a hands-on architect who can guide multidisciplinary teams (EE, FW & ME) to deliver safe, reliable, and manufacturable products under ISO 13485 design controls.
Key Responsibilities
- Define system and hardware architecture for medical devices.
- Translate user needs into hardware requirements and design specifications.
- Lead schematic design, PCB architecture, component selection, and power-management design.
- Ensure compliance with medical standards (IEC 60601-1, 60601-1-2, ISO 13485, ISO 14971).
- Support risk analysis, verification/validation testing, EMC testing, and design reviews.
- Collaborate with firmware, mechanical, and manufacturing teams.
- Drive DFM/DFA and support design transfer to manufacturing partners.
- Provide technical leadership and mentor junior engineers.
- Contribute to team building, talent acquisition, and presales support functions.
Required Qualifications
- Bachelor's/Master's in Electrical/Electronics Engineering.
- 15+ years of experience in hardware design, preferably in medical devices.
- Strong hands-on experience with analog/digital design, power electronics, sensors, RF/communication modules, and PCB design tools (Cadence Allegro).
- Experienced in the selection of active, passive, and intelligent components, including microprocessors, FPGAs, and related hardware.
- Experience in BOM analysis and identifying costsaving opportunities to improve overall product cost productivity.
- Knowledge of product life cycle.
- Knowledge of medical safety, EMC, and regulatory requirements.
- Experience with H/W & S/W integration, hardware debugging with lab equipment.
- Knowledge on the Signal Integrity, PCB Layout Guidance.
- Good knowledge on the circuit analysis.
Preferred Skills
- Experience with medical devices.
- Familiarity with embedded systems and firmware concepts.
- Experience working with test labs and manufacturing partners.
- Strong documentation discipline and understanding of design controls.
Soft Skills
- Clear technical communication for clients.
- Good presentation skills.
- Leadership and mentorship across multidisciplinary teams.
- Structured problem-solving, risk-based decision-making, and documentation rigor.
