Senior Electrical Engineer

NIRSense Inc. • Durham, NC

6d

About The Position

We are seeking a highly skilled Senior Electrical Engineer with a strong background in medical device development. The ideal candidate will have extensive experience in designing and integrating electrical components for miniaturized medical device systems, with a focus on mixed-signal circuit design, low-power architectures, and adherence to safety and EMC standards. This role involves leading complex projects from concept to validation, managing external vendors, and contributing to regulatory submissions.

Requirements

• 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.

Nice To Haves

• 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.

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior