What are the responsibilities and job description for the Principal Electrical Engineer position at Enterra Medical, Inc.?
Principal Electrical Engineer
St. Louis Park, MN
Job Summary
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.
Key Responsibilities
Required:
St. Louis Park, MN
Job Summary
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.
Key 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.
Required:
- 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.
- 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.
- Excellent problem-solving and analytical skills with a focus on reliability and patient safety.
- Strong communication skills for cross-functional collaboration and technical documentation.
- Ability to work in a fast-paced, regulated environment with attention to detail.
Salary : $160,000 - $185,000