Electrical Engineer Ii

About the Role

We are seeking an Electrical Engineer II to join our Research & Development team, designing and developing electrical and electronic systems for next-generation implantable Continuous Glucose Monitor (CGM). This role is ideal for an engineer with a strong technical foundation who is ready to take on increasing ownership of circuit design, design testing, design verification through design controls within a regulated medical device environment. You will collaborate closely with mechanical, firmware, systems, and quality engineers throughout the product development lifecycle — from concept through verification and design transfer.

Key Responsibilities

• Design, simulate, and prototype analog and digital circuits (e.G., signal conditioning, power management, sensor interfaces or battery/charging systems) for implantable and non-implantable medical devices.
• Develop schematics, PCB layouts, and bill of materials (BOM) in collaboration with mechanical engineers and vendors.
• Select components based on performance, reliability, cost, availability, and regulatory requirements (e.G., biocompatibility, EMC/EMI, electrical safety)
• Build and test prototypes;
  perform bench-level debugging, characterization, and root-cause analysis
• Support design verification and validation (V&V) activities, including writing test protocols, executing tests, and documenting results
• Contribute to risk management activities (e.G., FMEA) related to electrical subsystems
• Ensure designs comply with applicable standards (e.G., IEC 60601-1, IEC 60601-1-2, ISO 14971) and support regulatory submissions with technical documentation
• Collaborate with cross-functional teams (firmware, mechanical, systems, quality, regulatory) to integrate electrical subsystems into complete device designs
• Participate in design reviews and maintain thorough documentation per design control procedures (DHF, design inputs/outputs, traceability)
• Support manufacturing and test engineering teams during design transfer and production ramp-up
• Investigate and resolve field or manufacturing issues related to electrical performance

Required Qualifications

• Bachelor's degree in Electrical Engineering
• 2–5 years of relevant experience in electrical/electronic design, preferably in medical devices or another regulated industry (automotive, aerospace, industrial controls)
• Strong deep understanding of analog and digital circuit design fundamentals
• Experience with schematic capture and PCB design tools (e.G., Altium Designer, OrCAD, Eagle or similar)
• Familiarity and hands on experience with lab equipment for testing and debugging (oscilloscopes, multimeters, power supplies, function generators, logic analyzers)
• Strong problem-solving skills and attention to detail
• Excellent written and verbal communication skills;
  ability to document work clearly for design history files
• Ability to plan, execute and complete deliverables effectively and efficiently for the scope of work owned.

Preferred Qualifications

• Experience with battery-powered or wireless medical devices
• Familiarity with embedded systems and firmware/hardware interaction
• Experience with wireless communication protocols (Bluetooth Low Energy, Wi-Fi, NFC)
• Working knowledge of design control processes and experience operating within a regulated environment (FDA QSR / ISO 13485)
• Understanding of relevant standards such as IEC 60601-1 (medical electrical equipment safety) and EMC requirements
• Knowledge of DFM/DFT principles and experience supporting manufacturing transfer
• Exposure to sensor technologies (biopotential, optical, pressure, temperature)
• Experience with statistical tools for test data analysis (Minitab, JMP)
• Prior experience supporting FDA submissions (510(k), PMA) or CE marking (MDR)