Medical Device Validation Engineer Jobs in Raleigh, NC

About the Company:

NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a growing team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.

Job Summary:

NIRSense is seeking an experienced principal-level electrical engineer to serve as a technical leader within our growing engineering and scientific team in its Morrisville, NC office. This person will own and drive the complex hardware development efforts across NIRSense's product portfolio, working closely with a multi-disciplinary team of engineers to design and develop cutting-edge electronic circuits and systems for non-invasive medical devices. The ideal candidate brings deep expertise in biomedical sensing hardware, a track record of independently delivering sophisticated miniaturized systems, and the ability to mentor and elevate the engineers around them.

Please note this position is onsite, with flexibility.

Minimum Qualifications:

• 10+ years of experience in electrical engineering, with significant focus on medical devices or biomedical sensing systems.
• Demonstrated ability to independently lead and deliver complex medical device hardware development projects from concept through design verification and validation.
• Deep hands-on expertise with design and integration of electrical components of miniaturized medical device systems such as PCBs, PCB components, batteries, and light-emitting and detecting systems.
• Expertise in mixed-signal circuit design for physiological sensing, including signal generators, amplifiers, filters, ADCs, and low-noise data acquisition systems.
• Experience designing low-power architectures and battery management systems for body-worn medical devices.
• Experience with EMC/EMI design practices and electrical safety standards (IEC 60601-1, IEC 60601-1-2).
• Experience leading formal design reviews and presenting technical analyses to cross-functional stakeholders in a design-controlled environment.
• Proficiency in PCB design tools (Altium Designer preferred), including rigid, flex, and rigid-flex designs for space-constrained wearable form factors.
• Strong technical writing skills, with experience authoring design documentation for regulated environments.
• Proven ability to mentor engineers and elevate the technical quality of a team.
• Experience managing PCB fabricator and contract manufacturer relationships, including vendor qualification and supply chain risk mitigation.
• B.S. in Electrical or Biomedical Engineering or a related field.

Preferred Qualifications:

• Knowledge of biosensing and electrical stimulation technologies and proficiency in hardware implementations of these technologies.
• Experience with optoelectronic circuit design, including LED drivers, photodiode front-ends, and transimpedance amplifiers (TIAs).
• Experience with mechanical-electrical integration for miniaturized wearable enclosures and collaboration with mechanical engineering teams.
• Familiarity with C/C++ and embedded systems integration with BLE-enabled microcontrollers (e.g., Nordic nRF series) for wireless physiological data streaming.
• Experience directing and reviewing work from external PCB layout and design contractors.
• Experience designing medical wearable hardware for manufacturability (DFM) and testability (DFT), including development of test fixtures and validation systems.
• Experience with design verification and validation (V&V) testing in a regulated medical device environment.
• Experience supporting FDA regulatory submissions (e.g., 510(k), de novo) and familiarity with design controls under 21 CFR Part 820 or ISO 13485.
• Experience with hardware FMEA and risk management per ISO 14971.

Job Responsibilities:

• Serve as the technical lead on the miniaturized and ruggedized analog and mixed-signal electronics development efforts for medical physiological sensors, including EEG, ECG, and biophotonics-based systems.
• Design low-power architectures, battery charging circuits, and power budgets for portable and wearable device platforms.
• Design for safety and electromagnetic compatibility (EMC/EMI), conduct pre-compliance testing, and support formal EMC and electrical safety testing per IEC 60601-1 and IEC 60601-1-2.
• Drive and lead design reviews with multi-disciplinary stakeholders, establishing rigorous engineering practices and collaborating closely with firmware, mechanical, and software engineers to ensure seamless system integration.
• Independently manage relationships with PCB fabricators and assemblers; oversee BOM cost, sourcing risk, and component lifecycle to supply finished, high-quality electronics.
• Lead test fixture design and manufacturing test strategy, from prototype PCB evaluation through design transfer and production yield optimization.
• Author and review technical reports, maintain schematic libraries and design history files (DHF), and contribute hardware FMEA and risk management files (ISO 14971) to support regulatory submissions (510(k), de novo).
• Mentor junior and senior engineers, providing technical guidance, design feedback, and career development support.
• Report to the Electrical Engineering R&D Manager.