XII Medical, Inc. is a clinical-stage medical technology company revolutionizing the treatment of obstructive sleep apnea. The next-generation system aims to increase patient compliance by reducing surgical invasiveness and improving the patients sleeping habits.
Essential Responsibilities: Design, develop, and implement test fixtures, including all required documentation Perform hands-on testing, including data capture, analysis, and documentation Collaborate with system engineers, software engineers, and quality assurance teams to develop and execute system test plans, test cases, and test scripts based on product requirements and specifications Perform system-level testing, including functional, performance, usability, and reliability testing, for medical devices under development Document test results, analyze data, and report any discrepancies, defects, or issues in a clear and concise manner Assist in the setup and maintenance of test environments, including hardware, software, and test equipment Conduct root cause analysis and work with cross-functional teams to resolve identified issues Maintain detailed test documentation and support the creation of verification and validation reports Support the development and improvement of test processes and procedures to enhance testing efficiency and effectiveness Educational Requirements: Bachelor's degree in Bio-Medical Engineering, Mechanical Engineering or a related field Qualification Requirements: 1+ year of experience in the medical device sector designing, developing, and implementing test fixtures to support design verification CAD experience required Strong understanding of engineering principles and testing methodologies Familiarity with medical device development processes and regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, and IEC 60601, is a plus Basic knowledge of software development and scripting languages (e.g., Python, C, MATLAB) is a plus Excellent problem-solving skills and attention to detail Strong communication and teamwork skills with the ability to work effectively in a collaborative environment Ability to learn new tools, technologies, and methodologies quickly Passion for medical technology and a commitment to improving patient outcomes Travel Requirement: Domestic ability to travel required to contract manufacturer sites and other vendors, as needed Check out our recent news: https://www.prnewswire.com/news-releases/xii-medical-raises-45-million-in-series-b-financing-to-advance-best-in-class-neuromodulation-therapy-for-obstructive-sleep-apnea-302227451.html?tc=eml_cleartime