Staff R&D Electrical Engineer

Overview

The Staff R&D Electrical Engineer plays a key role in developing next-generation medical devices for the treatment of peripheral vascular and structural heart diseases. This individual will lead the design and development of complex electronic systems, working closely with cross-functional teams throughout the product lifecycle, from concept and prototyping through regulatory validation and commercial launch. The position requires deep expertise in mixed-signal electronics, embedded systems, microcontrollers, and FPGA design within a highly regulated medical device environment.

Key Responsibilities

• Lead the design and development of analog and digital electronics, embedded systems, microcontrollers, and FPGA-based solutions for medical devices.
• Translate customer and clinical needs into technical requirements, product specifications, and innovative design solutions.
• Create schematics, PCB layouts, and prototypes using industry-standard design tools (Altium preferred).
• Drive product development activities including architecture definition, design reviews, testing, verification, validation, documentation, and production transfer.
• Apply Design for Manufacturability (DFM), Design for Testability (DFT), and Design for Assembly (DFA) principles.
• Troubleshoot and resolve complex hardware issues at both system and component levels.
• Collaborate with systems, software, mechanical, manufacturing, and quality teams to ensure successful product execution.
• Develop and document test plans, participate in risk management activities (dFMEA, hazard analysis), and ensure compliance with medical device standards.
• Support intellectual property development through invention disclosures and patent contributions.
• Provide technical leadership on assigned development projects and support pilot manufacturing activities.

Qualifications

• Bachelor's degree in Electrical Engineering with 8+ years of experience, or Master's degree with 6+ years of relevant experience.
• Strong background in analog/digital circuit design, PCB development, embedded systems, and FPGA programming (VHDL or Verilog).
• Experience with C for embedded systems and Python (or similar) for hardware test and automation tools.
• Proficiency with source control tools such as Git, SVN, or Mercurial.
• Demonstrated experience bringing products from concept through commercialization.

Preferred Experience

• Medical device development experience, particularly cardiovascular or catheter-based technologies.
• Familiarity with EN60601-1 medical electrical equipment standards.
• High-voltage electronics design experience.
• Experience working within regulated product development environments.