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Form of workJob Description
Electrical Engineer - Medical Device Innovation
Location: Austin, TX
Our client, a cutting-edge medical device company based in Austin and backed by private equity, is seeking a skilled Electrical Engineer to join our dynamic team. As an FDA EUA authorized company, we specialize in developing revolutionary rapid PCR point-of-care systems. If you are passionate about advancing healthcare through technology and have a background in medical devices or electronic devices, we invite you to be a key player in our mission to provide simple, affordable, rapid, and accurate testing for everyone.
Position Summary:
As an Electrical Engineer, you will be at the forefront of our product development, contributing to the design, development, support, and validation of electrical systems. You will lead the integration of advanced electronics, sensors, and control systems, ensuring that our products meet the highest standards of performance, reliability, and safety. Join our dedicated and diverse team of scientists, engineers, and professionals, and make a significant impact on the world of medical devices.
Responsibilities:
- Lead the electrical design and architecture of the base unit and cartridge system, focusing on analog and digital circuits, power management, communication interfaces, and control algorithms.
- Design and prototype complex PCBs, ensuring compliance with design specifications, performance targets, and regulatory requirements.
- Collaborate closely with software engineers to seamlessly integrate hardware components into the overall system architecture.
- Ensure that all electrical design activities adhere to applicable FDA regulations and standards within our regulated environment.
- Participate in the validation and verification of electrical systems, meeting FDA and safety agency requirements, and preparing relevant documentation for regulatory submissions.
- Lead investigations related to on-market products, identifying root causes of issues, and implementing effective resolutions in compliance with regulatory requirements.
- Collaborate with cross-functional teams to address obsolescence issues and implement solutions ensuring 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.
- Minimum of 3 years of proven experience in designing and developing complex electrical systems, preferably 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 microcontrollers, 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.
If you are a motivated and innovative Electrical Engineer with a passion for medical device technology, we encourage you to apply and be part of our exciting journey to transform healthcare. Join us in making a positive impact on global healthcare accessibility.
