Seeking a highly experienced Senior Principal Electrical Engineer with specialized expertise in electrochemical biosensing to lead the development of next-generation medical devices. This role requires deep technical knowledge in biosensor design, electrochemical systems, and medical device regulations to drive innovation in diagnostic and therapeutic applications.
As a Senior Principal Electrical Engineer, you will play a critical leadership role in the design, development, and optimization of cutting-edge electrochemical glucose sensor technology for diabetes management. You will provide technical expertise, drive innovation, and guide cross-functional teams to deliver safe, effective, and reliable medical devices that improve patient outcomes. Candidates must be willing to work in a fast-paced, multi-tasking, team environment.
Join a passionate team dedicated to transforming diabetes care through innovative sensor technology. You’ll have the opportunity to make a meaningful impact on patients’ lives and work with some of the brightest minds in the medical device industry.
Technical Leadership:
- Lead the electrical design and development of advanced electrochemical glucose sensor systems, including circuitry, embedded systems, and signal processing algorithms.
- Define and execute verification and validation strategies for sensor electronics, ensuring compliance with relevant medical device standards (ISO 13485, IEC 60601, etc.).
- Drive innovation through the evaluation and adoption of new materials, sensor architectures, and low-power electronics.
- Oversee design documentation, risk analysis, and failure mode analysis (FMEA) for sensor-related components.
- Interface with external partners, suppliers, and research organizations to advance sensor technology.
- Present technical findings and project updates to executive leadership and cross-functional stakeholders.
Design & Development:
- Architect electrical systems for continuous glucose monitors or other diagnostic platforms
- Develop signal conditioning circuits, analog front ends, and data acquisition systems for biosensor applications
- Design low-noise, high-precision potentiostat circuits and amperometric measurement systems
- Develop algorithms for signal processing, noise reduction, and biomarker detection
- Create electrical interfaces between biosensors and embedded systems
- Optimize sensor performance parameters including sensitivity, selectivity, and stability
- Drive innovation in sensor miniaturization, power optimization, and wireless connectivity
Technical Oversight:
- Collaborate with chemistry, mechanical, software, systems, and manufacturing teams to integrate sensor technology into commercial diabetes devices.
- Mentor and guide junior engineers and project teams in design best practices, troubleshooting, and root cause analysis.
- Review and approve electrical designs, test protocols, and validation procedures
- Lead design reviews and risk analysis activities
Regulatory & Quality:
- Ensure designs comply with FDA regulations (21 CFR Part 820), IEC 60601, and ISO 13485
- Support regulatory submissions including 510(k) and PMA applications
- Implement design controls and verification/validation protocols per medical device standards
- Partner with regulatory and quality teams to support submissions, audits, and compliance activities.
Required Knowledge and Experience:
Requires a Bachelor's degree and minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.
Nice to Have:
- 5+ years of hands-on experience with electrochemical biosensing systems
- Deep understanding of electrochemical principles (cyclic voltammetry, impedance spectroscopy, potentiometry)
- Experience with biosensor fabrication techniques and electrode materials
- Knowledge of biocompatibility requirements and sensor packaging for biological environments
- Experience with wireless communication protocols (Bluetooth, NFC) for medical devices
- Proficiency in circuit simulation tools (SPICE, Cadence) and PCB design (Altium )
- Deep knowledge of PCBA design and manufacturing processes
- Previous experience with continuous glucose monitoring or other implantable sensors
- Experience with ISO 14971 risk management processes
- Publication record in peer-reviewed journals related to biosensing
*This job is fully onsite in Northridge, CA*