Electrical Engineer

About Nuclein:

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Our visionis to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.

Please visit Nuclein.com for more information about our company's history, technology, and vision.

Position Summary:

The Electrical Engineer will play a pivotal role in the design, development, support and validation of electrical systems for Nuclein’s DASH system. The individual will be responsible for driving the integration of advanced electronics, sensors, and control systems, ensuring products meet the highest standards of performance, reliability, and safety. The individual will collaborate closely with Engineering team members, in addition to cross-functional teams including Assay Development, Customer Support, and Operations, to create innovative solutions and maintain product effectiveness.

Responsibilities:

• Lead the electrical design and architecture of the base unit and cartridge system, encompassing analog and digital circuits, power management, communication interfaces, and control algorithms.
• Design and prototype complex PCBs, ensuring they meet design specifications, performance targets, and regulatory requirements.
• Collaborate with software engineers to integrate hardware components seamlessly into the overall system architecture.
• Operate within an FDA-regulated environment, ensuring all electrical design activities adhere to applicable regulations and standards.
• Participate in the validation and verification of electrical systems to meet FDA and safety agency requirements and support the preparation of relevant documentation for regulatory submissions.
• Lead and participate in investigations related to on-market products, identifying root causes of issues and implementing effective resolutions in compliance with regulatory requirements.
• Collaborate closely with cross-functional teams to address obsolescence issues and implement solutions that ensure the long-term availability and reliability of components.
• Conduct thorough testing and validation of electrical systems, identifying and resolving issues to ensure product reliability and safety.
• Participate in the selection of key components and suppliers, considering factors such as quality, availability, and cost-effectiveness.
• Drive continuous improvement in design processes, documentation, and testing methodologies to enhance efficiency and product quality.
• Stay current with industry trends, emerging technologies, and regulatory standards relevant to medical device electronics.

Qualifications:

• Bachelor's degree in Electrical Engineering or a related field.
• At least 3 years of proven experience in the design and development of complex electrical systems, ideally within the medical device or diagnostic industry.
• Strong proficiency in analog and digital circuit design, PCB layout, and simulation tools (e.g., Altium, Cadence, SPICE).
• Familiarity with microcontroller, embedded programming, and real-time control.
• Knowledge of communication protocols such as USB, I2C, SPI, UART, and wireless technologies.
• Experience with regulatory compliance and standards in the medical device industry (ISO 13485, FDA regulations); ability to operate in an FDA-regulated environment.
• Demonstrated experience in supporting on-market products through investigations and obsolescence issue resolution.
• Excellent problem-solving skills and the ability to troubleshoot and debug complex systems.
• Effective communication and collaboration skills, with the ability to work in interdisciplinary teams.
• Strong attention to detail and commitment to producing high-quality, reliable products.