Hardware Engineer

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Job Title:
Hardware Engineer

About the Role

We are looking for a Hardware Engineer to design, develop, and support electronic hardware for medical devices. This role involves working closely with cross-functional teams to create reliable, safe, and regulatory-compliant products that improve patient outcomes.

Key Responsibilities

• Design and develop electronic hardware for medical devices, including schematic design, PCB layout, and component selection
• Support hardware architecture definition and design reviews
• Build and test prototypes; perform debugging, failure analysis, and design optimization
• Collaborate with firmware, mechanical, quality, regulatory, and manufacturing teams throughout the product lifecycle
• Ensure hardware designs comply with medical device standards and regulations (FDA, IEC, ISO)
• Support verification and validation (V&V) testing activities
• Prepare and maintain design documentation, including schematics, BOMs, test reports, and Design History Files (DHF)
• Participate in risk management activities (FMEA, hazard analysis)
• Support design transfer to manufacturing and resolve production-related issues
• Work with suppliers and contract manufacturers on component selection and qualification

Required Qualifications

• Bachelor’s degree in Electrical Engineering, Computer Engineering, or a related field
• Experience in hardware design, preferably within medical devices or other regulated industries
• Strong understanding of analog and digital circuit design
• Experience with schematic capture and PCB design tools
• Hands‑on experience with lab equipment (oscilloscopes, logic analyzers, multimeters, etc.)
• Familiarity with FDA Quality System Regulations and ISO 13485
• Strong problem‑solving and communication skills

Preferred Qualifications

• Master’s degree in Electrical or Computer Engineering
• Experience with low‑power design, embedded systems, or sensor‑based devices
• Knowledge of EMC/EMI design and testing (IEC 60601)
• Experience supporting FDA submissions and regulatory audits
• Experience with design for manufacturability (DFM) and design for testability (DFT)