Job Description

Job Title: Clinical System Tester

Job Summary: Natus Neuro is seeking an experienced Clinical System Tester with expertise in EEG (Electroencephalography) and/or PSG (Polysomnography) to join our team. You will play a vital role in ensuring the quality and reliability of our current product portfolio and next-generation medical devices, specifically focusing on clinical applications and environments.


The ideal candidate will thrive in a dynamic environment, collaborating with software, hardware, product security, and other engineering teams to test, verify, and document system performance across all product lines. This role is critical to ensuring our devices meet stringent regulatory requirements and deliver exceptional value to healthcare providers and patients.

Responsibilities:

Maintenance:

• Perform comprehensive manual and automated testing and verification of clinical systems for patient data collection, monitoring, analysis, and review, with a focus on EEG and/or PSG applications from a clinical perspective.
• Create, maintain, and update test protocols and documentation to ensure continued compliance and functionality from a clinical point of view.

Development:

• Use clinical experience to conduct rigorous testing and verification of systems integrating Android tablets, cloud workflows, Microsoft Azure, and Windows networking components.
• Use clinical experience to configure and verify multi-device setups, focusing on Microsoft Windows networking, cloud connectivity, web APIs, web applications, and portal functionality.
• Use clinical experience to create detailed verification reports documenting system setup, configuration, deviations, and verification results.

General Responsibilities:

• Leverage clinical expertise in EEG and/or PSG to train and educate other system testers and engineering teams. This includes providing insights into clinical workflows, best practices for testing clinical systems, and the specific requirements and challenges associated with EEG and PSG applications. Conduct regular training sessions, workshops, and knowledge-sharing meetings to ensure all team members are well-versed in the clinical aspects of system testing, enhancing the overall quality and reliability of our medical devices.
• Utilize clinical expertise in EEG and/or PSG to develop and refine test protocols based on detailed software requirements. Ensure these protocols are tailored to thoroughly and accurately verify the functionality and performance of clinical systems. This includes considering the unique aspects of clinical workflows and patient data handling, ensuring that all testing activities are aligned with clinical standards and regulatory requirements.
• Provide clinical expertise in the design and execution of test protocols for the current product portfolio and future Natus Neuro medical technology.
• Conduct detailed testing of web APIs and applications to ensure seamless integration and robust functionality.
• Identify, document, and manage software defects using JIRA or other similar tools.
• Prepare detailed verification reports to meet regulatory and quality assurance standards.
• Execute test automation scripts to enhance testing efficiency.
• Collaborate with cross-functional teams, including product security and other engineering departments, to provide clinical expertise, troubleshoot and verify features effectively.
• Ensure all testing activities adhere to relevant quality system procedures, including FDA, ISO, and GMP standards.

Required Qualifications:

• Proficiency in Windows networking, including advanced configuration and troubleshooting skills.
• Bachelor's degree in Computer Science, Engineering, or a related field, or 10 years of work experience.
• At least 5-10 years of experience in software/system testing or a clinical EEG/PSG role.
• Expertise in working with both Windows-based and Android-based systems.
• In-depth understanding of the Software Development Lifecycle (SDLC).
• Experience with issue-tracking tools such as JIRA or other similar tools.
• Strong written and verbal communication skills.

Desired Qualifications:

• Experience with web API and application testing.
• Proven experience in testing cloud-based systems, particularly those using Microsoft Azure.
• Familiarity with Android tablet ecosystems and workflows.
• Knowledge of FDA/cGMP/QSR/IEC and ISO standards specific to medical devices.
• Previous experience in the medical device industry, with a minimum of 2 years of relevant work.
• Hands-on expertise with test automation tools and scripting languages.
• Experience working in Agile development environments and participating in Scrum teams.