Software Test Engineer (Medical Device Industry)

About Us:Bright Uro is a startup medical device technology company headquartered in Irvine, CA. Our mission is to create meaningful change for millions of people dealing with lower urinary tract symptoms (LUTS) by building the next generation of diagnostic devices for Urology. By utilizing advanced hardware, software, and data science, our goal is to unlock new data streams and offer actionable insight for clinicians while prioritizing the patient experience.Essential Duties and Responsibilities: Ensuring quality of software, firmware products, internal engineering, and manufacturing software through rigorous testing and continuous process improvements.   Develop and execute test plans, test cases, and test scripts for mobile, web applications, and cloud-based platforms and ensure comprehensive test coverage. Create and maintain automated testing frameworks to streamline regression and system integration testing. Familiarity with automated test tool development, such as Zelos, is a plus. Verify and validate embedded firmware and related components. Conduct risk-based testing and maintain compliance with medical device regulations and standards (e.g. ISO 13485). Troubleshoot and document defects by performing root cause analysis, collaborating with developers and product teams Ensure compliance with standard operating processes, as defined by the Company's quality systems to support regulatory submissions, product commercialization, and post-commercialization. Collaborate with cross-functional teams (R&D, MFG, QARA).  Education andor Work Experience Requirements: Bachelor's or higher degree in Computer Science, Electrical Engineering, or a related field.  2+ years of experience in softwarefirmware quality engineering within the medical device space or other regulated industries. Familiarity with standards and certification processes for firmware, software, and electronic devices in the medical space. Experience working under ISO 13485 andor 21 CFR 820 regulation, including ISO 14971 Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving. Familiarity with defect tracking tools (e.g., Jira) and software version control tools (e.g., Git) Familiarity with cybersecurity risk management and guidelines is a major plus. Experience in JavaScript, Python, CC++ programming is a plus.  Additional Requirements: Excellent verbal and written communication skills - including the ability to contribute technically to and work within cross-functional team environments.  High level of personalprofessional integrity, trustworthiness, strong work ethic, and ability to work independently.Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, "can do" attitude and ability to work well under pressure.Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving. Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with Microsoft Teams is a plus. Prior startup experience preferred but not required.Physical Requirements: Must be able to lift up to 25 lbs.Must be able to work extended amounts of time standing or sitting based on projects and priorities. 

Created: 2025-02-21