- gwenross1
ELECTRICAL ENGINEER III
Indianapolis, IN
The Role
The Electrical Engineer III (EE) is primarily responsible for supporting Sonablate products that are currently on the market, the stewardship of products following the transfer from development into commercialization and supporting the development of new Sonablate products. As the Electrical Engineer III you will be responsible for the planning and execution of product design related to new products and changes and remediation activities to existing products by leading cross-functional teams and managing project execution from initiation through completion within the framework of Sonablate’s quality management system.
In addition to implementing new products, design changes that enhance performance, address quality issues, and maintain compliance to applicable standards, the Electrical Engineer III performs product investigations, determines root cause, identifies and implements corrections and corrective actions.
Responsibilities
Provide technical support for existing and new products by developing solutions for problems primarily of electrical/circuit nature with a level of accountability and minimal need for supervisory oversight
Research, verify, and implement the replacement of end-of-life components while sustaining current product design intents
Devise, define and implement new designs and solutions to existing products and actively participate in the design of new products, systems, and sub-systems
Generate test protocols and reports and execute product testing within Sonablate Fry Laboratory
Generate Engineering Change Orders to support product engineering and sustaining efforts
Maintain Design History Files and Technical File Documentation
Project planning and execution to ensure timely completion of tasks interface with all functional areas affected by products including R&D, Manufacturing, Quality, Regulatory, Clinical, Supply Chain, and Service as warranted
Present project status to stakeholders, management, and teams
Work to maintain product performance and quality of existing products by leading and assisting with issues related to CAPAs, customer complaints, and manufacturing processes
Follow strict adherence to policies and procedures associated with an FDA controlled environment
Provide direction and/or support to other Engineers
Qualifications
Bachelor’s or advanced degree in Electrical Engineering
5-10 years of experience in related field
Previous experience in medical device design is highly desirable
Expertise in circuit board layout, design, and manufacturing (both with digital and analog electronics), documentation, and testing in the RF range both low level and high-power signals up to several hundred watts
Hands-on experience with oscilloscopes, function generators, network analyzers, impedance analyzers, and power meters
Proficient in electrical assemblies: power, cabling, signaling, interfacing, RF, and shielding
Proficient in electro-mechanical assemblies: servo motors, stepper motors, and actuators
Microcontroller experience a plus
Design work under ISO 13485 a plus
The Company
Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.
Sonablate Corp. has two offices: one in Charlotte, NC and the other in Indianapolis, IN as well as remote employees spread out across the country. We stay focused by having monthly town hall meetings, tracking our progress toward annual goals, and passing all new projects through a rigorous vetting by our prioritization committee. We strive for transparency and clear communication throughout the company and look for candidates that want to dive in, effect change, and challenge us to become the best version of ourselves.
Our employees enjoy competitive salaries, bonus plans, and an employee stock option plan. Additionally, the company pays for 90% of the employee’s healthcare benefits, which are effective the first of the month following your first day on the job. We offer flexible working schedules for our hourly employees and a work-from-home policy for our salaried ones. We believe in giving our employees autonomy, mastery, and purpose and enjoy low turnover due to that philosophy.
Sonablate provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.
Equal Opportunity Employer