Principal Electrical Engineer
On-site · Morrisville, North Carolina, United States
Job Summary
Lead hardware development on miniaturized analog/mixed-signal electronics for medical physiological sensing systems (EEG/ECG/biophotonics). Design low-power architectures, battery charging, and power budgets for portable wearable platforms. Ensure EMC/EMI and electrical safety compliance (IEC 60601-1/60601-1-2); drive design reviews with firmware, mechanical, and software teams. Independently manage PCB fabrication and supplier relationships; lead test fixture design and production-transfer activities. Author and maintain design history files, contribute to ISO 14971 risk management, and support regulatory submissions (510(k), de novo). Mentor engineers and collaborate with cross-functional teams; report to the Electrical Engineering R&D Manager.
Required Qualifications
- B.S. in Electrical or Biomedical Engineering or a related field
- 10+ years of experience in electrical engineering, with focus on medical devices or biomedical sensing systems
- 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 (PCBs, batteries, LEDs/photodetectors)
- Expertise in mixed-signal circuit design for physiological sensing (signal generators, amplifiers, filters, ADCs, low-noise data acquisition)
- 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 in a design-controlled environment
- Proficiency in PCB design tools (Altium Designer preferred) for rigid, flex, and rigid-flex designs
- Strong technical writing skills; experience authoring design documentation for regulated environments
- Proven ability to mentor engineers and elevate technical quality
- Experience managing PCB fabricator and contract manufacturer relationships, including vendor qualification and supply chain risk mitigation
- Mentor junior and senior engineers; report to Electrical Engineering R&D Manager
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