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 patient's 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