Hardware Architect

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.