Principal Electrical Engineer

Enterra Medical, Inc.Minneapolis, MN
3d$160,000 - $185,000

About The Position

We are seeking an experienced Principal Electrical Engineer to lead the electrical design and development of next-generation active implantable medical devices (AIMDs). This role involves architecting complex analog, digital, and mixed-signal circuits while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into manufacturable, high-performance products.

Requirements

  • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field.
  • 10+ years of experience in electrical hardware design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices).
  • Expertise in analog and digital circuit design, low-power mixed-signal electronics, power electronics, and control systems.
  • Proven track record in medical device development, including full product lifecycle from concept to commercialization.
  • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management.

Nice To Haves

  • Master's or Ph.D. in Electrical Engineering or related field.
  • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems.
  • Familiarity with ultra-low-power custom ASIC fabrication, wireless power transfer, or adaptive algorithms.
  • Experience and or understanding in embedded firmware design preferable
  • Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits.
  • Proficiency in tools such as Altium, SPICE simulation, MATLAB/Simulink, or similar.

Responsibilities

  • Lead the design, development, prototyping, and testing of electrical hardware for implantable devices, including analog/mixed-signal circuits, low-power electronics, power management systems, and wireless communication interfaces (e.g., BLE, RF telemetry).
  • Architect system-level electrical designs, considering implantable constraints such as ultra-low power consumption, biocompatibility, miniaturization, hermetic packaging, and long-term reliability.
  • Perform circuit simulation, schematic capture, PCB layout oversight, and hardware verification/validation, including ISO14708 (e.g. EMC/EMI testing).
  • Conduct risk analyses (e.g., dFMEA), root cause investigations, and failure mode testing to ensure device safety and efficacy.
  • Collaborate with cross-functional teams (firmware, mechanical, systems, clinical, and quality engineering) to integrate electrical subsystems and support closed-loop therapies.
  • Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, ISO14708, and IEC 60601 series.
  • Mentor and provide technical guidance to junior electrical engineers; lead design reviews and contribute to strategic technology roadmaps.
  • Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions.
  • Stay current with advancements in implantable electronics, such as custom ASIC development, battery technologies, and neuromodulation systems.
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