What are the responsibilities and job description for the System Test Engineer position at NIRSense Inc.?
Title: System Test Engineer
Location: Morrisville, NC
Anticipated Start Date: January 2025
About the Company:
NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a growing team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.
Job Summary:
NIRSense is seeking an experienced system test engineer to work alongside our growing engineering and scientific team in its Morrisville, NC office. This person will support a broad set of development objectives for NIRSense’s many customers. This person will integrate with a multi-disciplinary team of engineers to design, develop, and execute system test strategies for non-invasive medical devices. The ideal candidate is an experienced professional looking to apply their skills to deliver miniaturized biomedical sensing systems for NIRSense’s transformational capabilities.
Salary: The compensation package will be commensurate with the successful applicant’s experience.
Hours: Full time
Travel: up to 10%
Minimum Qualifications:
- B.S. or M.S. in Electrical, Software, Biomedical, or Computer Engineering (or a related field).
- Three or more years industry experience in system and component testing for wearable monitoring systems, medical devices, or similarly regulated industry.
- Hands-on experience with integration and testing of embedded firmware on custom circuit boards using Python scripts.
- Strong written and verbal communication skills for both technical and non-technical audiences.
- Demonstrated ability to succeed in a fast-paced and dynamic environment.
Preferred Qualifications:
- Experience testing medical devices with various biosensing modalities, including near-infrared spectroscopy, photoplethysmography, and electrocardiography.
- Familiarity with C/C and embedded systems with Bluetooth microcontrollers.
- Experience with test automation for embedded systems as well as mobile applications.
- Understanding of medical device test standards, including IEC 60601-1, IEC 60601-1-2.
- Experience designing and implementing tests per FDA usability guidance, including on-body tests.
- Experience working within an ISO 13485 quality management system.
- Prior experience working in a startup environment.
Job Responsibilities:
- Contribute to comprehensive test plans for medical physiological sensors, collaborating with NIRSense’s cross functional engineering team to ensure requirement traceability is met.
- Conduct thorough testing of features and bug fixes as needed by the engineering and research teams to confirm the successful implementation covering the performance, safety, and usability requirements of NIRSense products, confirming the seamless operation of hardware, firmware, and mobile applications.
- Participate in design reviews, risk analyses, and usability evaluations, providing the test engineer’s point of view toward Design for Test (DFT) product objectives.
- Analyze and troubleshoot complex issues related to optoelectronic and electrical sensing systems, collaborating with other engineers on root cause determination.
- Automate device testing where applicable to maximize repeatability and throughput of NIRSense test articles.
- Report software and device defects by providing detailed and reproducible test setup information within NIRSense’s task/issue tracking tools.
- Recommend improvements to NIRSense’s test workflow to improve defect detection across multiple product platforms
- Support test fixture development to ensure relevant test needs are accounted for in the design
- Support NIRSense’s regulatory efforts for system market approvals through both 510(k) clearances and de novo classifications through producing detailed and accurate verification and validation output documentation.
- Report to the Director of Engineering.
