Senior Hardware Engineer – Medical Devices

We are seeking a hands-on Hardware Engineer to lead the design, development, and validation of electronic hardware for next-generation medical devices. This role involves full ownership of the hardware platform, from concept through production, ensuring compliance with medical standards and regulatory requirements. The ideal candidate is passionate about building reliable, safety-critical systems and thrives in a collaborative, fast-paced environment. 

Description 

• We are looking for a hands-on Hardware Engineer to design, develop, and validate electronic hardware for innovative medical devices. 

• Design schematics and PCB layouts, ensuring compliance with medical device standards. 

• Collaborate with cross-functional teams, support design transfer, and deliver reliable hardware designs and documentation compliant with regulatory requirements. 

Requirements 

• 4+ years of hardware design experience for safety-critical or regulated systems. 

• Proficiency in schematic capture and PCB layout using modern EDA tools (e.g., Altium Designer, Cadence Allegro) 

• Strong knowledge of analog and digital circuit design, component selection, and PCB stack-up. 

• Perform circuit simulations using tools such as LTspice or equivalent.  

• Hands-on experience in hardware testing, debugging, and validation of prototypes using lab equipment, with the ability to translate designs into production-ready hardware. 

• Familiarity with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC/EMI), ISO 13485, and ISO 14971 standards for medical devices. 

• Strong understanding of DFM (Design for Manufacturability) and DFT (Design for Testability) 

• Ability to document designs and support traceability requirements for FDA compliance 

Preferred Qualifications 

• Experience with rigid-flex PCB and high-speed design. 

• Knowledge of EMC/EMI mitigation techniques and compliance testing. 

• Prior work in FDA-regulated or safety-critical hardware environments.