Senior Electrical Engineer

Senior Electrical Engineer NIRSense Inc. Morrisville, NC Job Details Full-time 15 hours ago Qualifications Developing medical devices Product design project leadership Managing medical device teams Report writing Content creation for technical audiences Managing projects in an engineering role Medical device testing Signal processing circuit design Electrical safety management Supply chain risk management Managing electrical projects Research and development in electrical engineering Technical writing within manufacturing Electronics test specifications Electrical safety procedures System design for system development Collaboration with product development teams Product development projects Production validation processes Electrical engineering training Compliance documentation Design engineering Printed circuit board (PCB) layout Vendor relationship management Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Managing projects Medical devices electrical engineering expertise Product design documentation

Full Job Description Minimum Qualifications:

5+ 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. 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:

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). Report to the Electrical Engineering R D Manager.