Systems Test Engineer

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:

• 2-5 years 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