Role Summary :

We are looking for a technically strong Embedded Hardware Technical Lead / SME with 3 - 10 years of experience in embedded electronics and product development, preferably within the medical device or other safety-critical industries.

Role : Senior Technical Lead / SME - Embedded Hardware Engineering

Experience: 3 - 10 Years.

Function: Healthcare & Medical Devices Engineering.

Role Type: Technical Leadership / Solutioning / Customer Engagement.

Location: Pune.

Key Roles & Responsibilities :

- Lead embedded hardware architecture and detailed hardware design activities for complex products.

- Analyze existing and new product architectures and recommend appropriate hardware solutions.

- Define hardware architecture, functional blocks, system interfaces, and HW/SW boundaries.

- Review schematics, PCB designs, component selection, BOMs, and engineering calculations.

- Provide technical guidance on:

1. Microcontrollers / Microprocessors / SoCs.

2. Analog and digital electronics.

3. Power supply and power management.

- Lead hardware troubleshooting, root-cause analysis, and design optimization.

- Medical Device / Product Development.

- Support development in accordance with applicable product development and quality processes.

- Strong understanding of design controls, requirements traceability, risk management, verification and validation.

- Understanding of electrical safety, EMC/EMI, usability and product compliance considerations.

- Work closely with systems, firmware, software, mechanical, V&V and manufacturing teams.

Required Technical Skills :

- Embedded hardware architecture and design.

- Analog and digital electronics.

- MCU/MPU-based designs.

- ARM-based platforms.

- ADC / DAC / signal conditioning.

- Ethernet, USB, UART, SPI, I2C, CAN and similar interfaces.

- EMI/EMC design considerations.

- Hardware bring-up and debugging.

- Obsolescence / component lifecycle management.

- DFMEA / risk analysis.

- DFM / DFT understanding.

Preferred Medical Device Knowledge :

- Knowledge of standards/processes such as :

1. IEC 60601 series.

2. ISO 14971.

3. ISO 13485.

4. IEC 62366.

- Medical device design controls and risk management.