Senior Electrical Engineer

The Sr. Electrical Engineer plays a key leadership role in the design and development of a Class III implantable neuromodulation system. In this role, you will be leading the technical team to make key and impactful decisions for electrical components in the system.

• Lead the design and development of Class III implantable neuromodulation systems, associated accessories, test systems, and manufacturing fixtures.
• Design and analyze electronic circuits, including:
  Embedded systems and firmware interfaces, Mixed-signal analog/digital circuits and Power management and charging circuits
• Own schematic design, PCB layout, component selection, BOMs, characterization, and system integration across all development stages.
• Establish electrical product requirements and specifications
• Design and execute experiments to validate concepts, develop new test methods, and generate design data.
• Characterize and verify hardware performance to ensure medical-grade precision and reliability.
• Drive design-for-reliability and manufacturability improvements.
• Train and mentor contract manufacturing engineers and technicians on product testing and troubleshooting methods.
• Participates in the design and execution of verification testing protocols, methods and reports to ensure products meet design requirements
• Supports risk management documentation including hazard analysis and failure modes and effect analysis (FMEA) to identify and mitigate design and process risks
• Partner closely with system, firmware, mechanical, and test engineering teams to ensure full system integration and performance alignment.
• Contribute to the company’s intellectual property portfolio through innovative concepts and technical disclosures.
• Operate in compliance with design controls and quality system procedures.
• Prepare technical reports, presentations, and design reviews for management and cross-functional stakeholders.
• Communicate with physicians and other clinicians on product design and development activities and gather feedback on product prototypes
• Collaborate with Marketing, Regulatory, and Quality to ensure design inputs and verification activities align with product and business objectives.

• Bachelor’s degree with 8 years, Master’s degree with 6 years, or PhD with 3 years of related experience with development or verification in the medical device industry (Class III medical device experience preferred).
• Minimum 5 years of experience in a regulated industry; medical device experience strongly preferred.
• Strong expertise in embedded system design, mixed-signal electronics, and power electronics.
• Demonstrated ability to plan, develop, coordinate, and direct significant engineering programs or multiple smaller projects with complex features, leveraging both internal and external resources.
• Serve as a technical consultant to the project team, helping solve challenging design issues, providing training, and bridging knowledge across disciplines.
• Working familiarity with FDA submission processes, ISO standards (13485), and Quality System Regulation (QSR) requirements.
• Experience working with relevant product development standards, guidelines, and regulations (60601, 14708, 14971, FCC)
• Experienced in software engineering, with the ability to guide firmware development or create hardware-characterization tools (languages such as C, Assembly, and Python).