Principal Electrical Engineer

Principal Electrical Engineer

Direct Hire | Onsite | M-F, 8am-5pm

The Principal Electrical Engineer is a hands-on technical leadership role responsible for the electrical design, verification, and transfer to manufacturing of handheld, battery-powered electroporation device platform, with particular focus on compact, potted high-voltage (10 kV and above), low-current modules.

Key elements of the role:

High-Voltage Module Design: Own the design of potted high-voltage, low-current generation, sensing, and protection circuitry from concept through production.

Electrical Design Authority: Serve as senior technical authority for electrical engineering, establishing electrical design standards and practices that carry forward across the company's product roadmap.

Design Controls and Compliance: Execute electrical design and development under 21 CFR Part 820 (QMSR) and ISO 13485:2016, and drive compliance with IEC 60601-1 and IEC 60601-1-2.

Manufacturing Transfer: Partner with the contract manufacturing organization (CMO) to transfer, validate, and sustain high-voltage module and electronics assembly processes, including potting and production test.

Cross-Functional Partnership: Work closely with the Chief Technology Officer, mechanical, firmware/software, quality, and regulatory teams, combining hands-on bench work with disciplined schedule and risk management.

Responsibilities :

Electrical and High-Voltage Design Responsibilities

• Own schematic capture, circuit design, and PCB layout for the company's electronic hardware, including high-voltage, power, sensing, processing, and user-interface subsystems
• Design and characterize high-voltage generation topologies (e.g., resonant converters, flyback, Cockcroft-Walton multipliers), including specification and qualification of custom high-voltage magnetics
• Design high-impedance feedback and nA-to-µA current sensing circuits, and control output regulation and drift across temperature, humidity, and aging
• Engineer insulation systems, creepage/clearance, and corona/partial-discharge mitigation for potted high-voltage assemblies, including selection of encapsulation materials
• Design, troubleshoot, and verify electronic circuitry, including electrical isolation, noise mitigation, safety-critical arc, fault, and energy-limiting protection
• Select appropriate power topologies and specify components with appropriate ratings, creepage/clearance, and safety margins consistent with IEC 60601-1 means of protection (MOOP/MOPP) and applied part classification
• Apply sound signal- and power-integrity design practices, and introduce formal design-for manufacturability (DFM) and design-for-test (DFT) methodology into the design process

Verification and Compliance Responsibilities

• Plan and execute circuit characterization, bench verification, and margin analysis across Engineering Sample (ES), Engineering Prototype (EP), Pre-Production (PP), and Production build stages, through design freeze and design transfer
• Define high-voltage verification methods, including hipot, partial discharge, insulation resistance, and leakage and touch current measurement, and destructive physical analysis (e.g., cross sectioning, void inspection) of potted assemblies
• Support electrical safety, EMC, and battery safety compliance activities (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62133-2) and pre-compliance testing, coordinating with outside test labs toward third-party test reports and certification
• Author electrical DFMEA and hazard analysis inputs to the risk management file under ISO 14971,
• and maintain traceability from electrical requirements through verification results
• Manufacturing Transfer and Sustaining Responsibilities
• Manage bill-of-materials, component sourcing, and long-lead-part planning; own electrical release packages to the contract manufacturing organization (CMO)
• Develop and validate high-voltage module manufacturing processes with the CMO, including potting and encapsulation process validation (IQ/OQ/PQ), and define 100% production hipot and functional test methods and fixtures
• Plan and execute reliability testing (e.g., thermal cycling, temperature-humidity-bias, accelerated life), and monitor production yield and field performance
• Support pilot builds, first-article inspection, and line qualification, and lead root-cause analysis and initiate engineering change orders (ECOs) through formal design change control for sustaining issues and complaint investigations after launch

Cross-Functional Collaboration Responsibilities

• Partner with program/project management to integrate the electrical engineering development plan into the overall program schedule and provide realistic engineering estimates
• Present electrical design status, risks, and results at formal design reviews, and mentor engineers and technicians in electrical and high-voltage design practices
• Coordinate with firmware/software engineering on hardware/software interfaces, and with mechanical engineering on high-voltage packaging, thermal, and enclosure design

Skills & Abilities

• Experience at the principal or staff level as the senior electrical engineering authority on a product development team
• Power electronics experience, including DC-DC conversion and battery-powered handheld systems, with high-voltage, low-current module design (e.g., voltage multipliers, custom high-voltage magnetics, nA-to-µA current sensing)
• Working knowledge of EMC/EMI principles and safety testing, and experience designing for compliance with standards such as IEC 60601 or equivalent (UL, IEC 62368, etc.)
• Experience with potted or encapsulated high-voltage assemblies and high-voltage test methods, including partial discharge and hipot testing
• Experience taking a design through formal verification/validation phases (EVT/DVT/PVT or equivalent) and transferring designs to contract manufacturing
• Direct FDA design control experience under 21 CFR Part 820 (QMSR) and ISO 13485:2016, and experience with other high-voltage therapeutic devices
• Communication: Communicate effectively in writing and verbally with technical and non-technical audiences, including design reviews, test reports, and regulatory documentation
• Technical Expertise: Strong hands-on bench skills, including high-voltage measurement, schematic capture, PCB layout, and circuit characterization
• Leadership & Influence: Set electrical design standards, lead technical discussions, and mentor engineers, with the ability to build and lead an electrical engineering team as the organization grows
• Collaboration: Collaborate effectively in a small cross-functional team, on-site and with external partners such as the CMO and test labs
• Problem-Solving & Analytical: Excellent critical thinking, troubleshooting, and root-cause analysis skills, using data and structured methods
• Project Management: Plan and prioritize work, provide realistic estimates, and deliver to program milestones
• Adaptability: Work independently with limited direction in a resource-constrained startup, adjusting as priorities change

Qualifications:

• Bachelor's degree in Electrical Engineering required; Master's degree in Electrical Engineering or closely related field preferred
• 10+ years of hands-on electronics design experience, including schematic capture and PCB layout, through multiple product releases
• Hands-on design experience with high-voltage circuits of 10 kV or greater.
• Medical device industry experience is preferred
• Experience at the principal or staff level as the senior electrical engineering authority on a product development team preferred
• Power electronics experience, including DC-DC conversion and battery-powered handheld systems, with high-voltage, low-current module design (e.g., voltage multipliers, custom high-voltage magnetics, nA-to-µA current sensing) preferred
• Working knowledge of EMC/EMI principles and safety testing, and experience designing for compliance with standards such as IEC 60601 or equivalent (UL, IEC 62368, etc.) preferred
• Experience with potted or encapsulated high-voltage assemblies and high-voltage test methods, including partial discharge and hipot testing preferred
• Experience taking a design through formal verification/validation phases (EVT/DVT/PVT or equivalent) and transferring designs to contract manufacturing preferred
• Direct FDA design control experience under 21 CFR Part 820 (QMSR) and ISO 13485:2016, and experience with other high-voltage therapeutic devices preferred

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at View phone number on click.appcast.io, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.

Pay Scale of Starting Pay for role: $150,000-$185,000 DOE