Sr Electrical Engineer

Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system. Their product is easy-to-use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world!

As they continue to grow exponentially, they are looking to add a Senior Electrical Engineer to the team, who will play a pivotal role in the design, development, and validation of electrical systems for their product. The best for this 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. In this role, you will collaborate closely with cross-functional teams, including Engineering, Assay Development, Customer Support, and Operations to create innovative solutions and maintain product effectiveness.

What’s in it for YOU? 

• They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.
• A wonderful company culture with great core values and looking for team players who also align with them – Value Everyone, Ownership, Innovation, Collaboration and Excellence Driven! 
• Very exciting time to work with an awesome leadership team has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering and manufacturing. 
• This company is in growth mode and is bound for great things! This is an opportunity for you to help make a significant difference with this delivery to the world!

What YOU get to DO at this growing company:

• 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.
• Develop and implement sensor technologies for accurate diagnostic measurements, collaborating with the sensor development team.
• 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.

What you NEED to SUCCEED in this challenging role:

• Bachelor’s degree in electrical engineering or a related field. Advanced degree is a plus.
• At least 5 years of 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 and FPGA-based systems, 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.

INDSJ