Senior Electrical Engineer - Medical Device

Our client is dedicated to transforming patient care through innovative, life-saving medical technologies. Their team is composed of mission-driven professionals committed to delivering high-quality solutions that improve health outcomes across the globe. They are seeking a highly skilled Senior Electrical Engineer to join their R&D team in developing next-generation medical devices. This role requires deep expertise in analog and digital circuit design, PCB layout, and system integration, along with a strong understanding of regulatory requirements in the medical device industry. The ideal candidate will contribute across the product development lifecycle-from concept to production-ensuring safety, reliability, and compliance. Key Responsibilities

• Lead the electrical design and development of Class II/III medical devices.
• Design analog, digital, and mixed-signal circuits for embedded systems, sensors, and power management.
• Own schematic capture and PCB layout using tools such as Altium or OrCAD.
• Perform circuit simulation, analysis, and bring-up of prototypes.
• Conduct design verification and validation in accordance with IEC 60601 and FDA standards.
• Support risk management and design failure modes analysis (DFMEA).
• Collaborate cross-functionally with mechanical, software, and quality teams.
• Participate in sustaining engineering and product improvement initiatives.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and relevant standards.

Qualifications

• Bachelor's or Master's degree in Electrical Engineering or related field.
• 7+ years of experience in electrical hardware development, preferably in a regulated medical device environment.
• Strong background in analog and digital circuit design, microcontrollers, sensors, and power supply systems.
• Experience with design tools such as Altium Designer, OrCAD, SPICE, etc.
• Familiarity with medical device standards (IEC 60601, ISO 14971, etc.).
• Knowledge of EMI/EMC design principles and compliance testing.
• Excellent problem-solving, documentation, and communication skills.
• Experience working within an FDA or ISO 13485-compliant quality system.

Preferred Qualifications

• Experience designing for manufacturability (DFM) and reliability (DFR).
• Experience with wireless technologies (BLE, Wi-Fi, NFC) and battery-powered systems.
• Prior involvement in successful submission of 510(k) or PMA applications.