Electrical Engineering Manager
Elliquence
Full-time
On-site
Baldwin, New York, United States
Location: Baldwin
Job Type: Full-TimeJob Summary:
We are seeking an experienced Senior Electrical Engineering Specialist / Electrical Engineering Manager to lead the development of innovative medical devices. This role requires expertise in circuit design, embedded systems, power management, and electronics for regulated medical devices. The candidate will ensure compliance with medical industry standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820), and be driving the successful development of Class I, II, or III medical devices.Key Responsibilities:
Job Type: Full-TimeJob Summary:
We are seeking an experienced Senior Electrical Engineering Specialist / Electrical Engineering Manager to lead the development of innovative medical devices. This role requires expertise in circuit design, embedded systems, power management, and electronics for regulated medical devices. The candidate will ensure compliance with medical industry standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820), and be driving the successful development of Class I, II, or III medical devices.Key Responsibilities:
- Lead the electrical engineering team in design, development, and testing of electronic systems for medical devices.
- Architect, design, and validate analog and digital circuits, power electronics, and embedded control systems.
- Oversee PCB layout, schematic design, and component selection to optimize performance, reliability, and manufacturability.
- Develop real-time embedded systems (firmware and software) for microcontrollers, DSPs, and FPGAs.
- Ensure compliance with medical device regulatory standards and safety requirements (IEC 60601, ISO 13485, FDA 21 CFR 820).
- Conduct risk analysis, failure mode analysis (FMEA), and design verification/validation (V&V).
- Collaborate with cross-functional teams (mechanical, software, regulatory, and manufacturing) to integrate electrical systems with other subsystems.
- Drive design reviews, documentation, and technical reports to support regulatory submissions (510(k), PMA, CE Marking).
- Manage supplier relationships for custom components, contract manufacturing, and PCB assembly.
- Lead troubleshooting, debugging, and root cause analysis of electrical failures in development, production and post-market surveillance.
- Stay updated on industry trends, emerging technologies, and medical device innovation to enhance product design.
- Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, or related field.
- 4+ years of experience in electrical design for medical devices, including leadership roles.
- Proven experience in analog/digital circuit design, power management, sensor integration, and high-speed data acquisition.
- Strong expertise in embedded systems development, including C/C++, RTOS, FPGA programming (Verilog/VHDL).
- Hands-on experience with SPICE simulation, PCB design (Altium, OrCAD, Eagle), and EMI/EMC testing.
- Knowledge of wireless communication protocols (Bluetooth, Wi-Fi, NFC) and cybersecurity considerations.
- Understanding of biocompatibility, sterilization, and safety standards for medical electronics.
- Experience with ISO 13485, FDA 21 CFR Part 820, IEC 60601-1, ISO 14971, and risk management processes.
- Strong leadership and project management skills with the ability to mentor and develop engineering talent.
- Excellent communication skills for technical documentation, design reviews, and collaboration with regulatory bodies.
As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.
What we offer:
Base salary and annual performance-based bonus.
Medical, dental, vision and life insurance
401(k)