Who we are
binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing for large corporate partners to broaden access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work, and shop. Our at-home solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.
We are looking for a Systems Engineer to lead engineering technical insight within the business and develop engineering solutions for the existing product range or for new products. Additionally, we are looking for a Systems Engineer to drive and oversee investigation and development activities from an engineering perspective. This person will plan and evaluate network technologies to enable, enhance, and support connectivity and integration. This role will provide device integration engineering services to research areas including selection, acquisition and service, technical investigations, and clinical/technical problem-solving. They will also lead quality improvement activities and suggests innovative solutions to technical problems.
- Maintain an overview of all technical aspects of the io platform and cartridges including firmware, software, and system cartridge interfaces
- Provide technical expertise at the system level to align technical teams on hardware and supply components.
- Assess existing system architecture and recommend improvements, enhancements
- Maintain the instrument DHF
- Plan and lead new hardware developments and a pipeline for the io and cartridge platform.
- Define the scope of verification testing and provide key support for verification and validation activities. Complete testing protocol, analyze reports.
- Prepare documents for and support regulatory submissions
- Investigate and develop solutions and new opportunities in the io and cartridge platform
- Monitor reliability and performance in the io platform
- Steer requirements for software developments on the io platform
- Supports security management process including risk and vulnerability analysis and related documentation associated with interconnected and integrated devices and systems.
- Interface with the R&D team to bring solutions to new and existing products including streamlining current processes and idea invention
- Troubleshoot and investigate errors and faults, lead root cause analysis, and plan remedial actions.
Education, Experience, and Demonstrated Skills
- Bachelor’s degree in Clinical Engineering, Biomedical Engineering, Systems Engineering, or related engineering field.
- At least 10 years experience in healthcare or molecular engineering with demonstrated experience with FDA QSR and ISO 13485
- Experience developing products in an IVD diagnostic development, including use of Statistics in experimental design
- Strong understanding of mechanical, electronic, and software design principles
- General understanding of molecular biology focused on PCR and sample preparation.
- Strong skills in the management of engineering projects and/or personnel
- Ability to diagnose and solve technical and/or system problems of a high degree of complexity
- Knowledge of electronic, mechanical, and/or computer reengineering design and applications principles
- Knowledge of clinical systems architecture used for medical device interoperability
- Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools, and programming.
Employees may be required to lift routine office supplies and use office equipment. The majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
binx health, Ltd. is an Equal Opportunity Employer
For interested applicants, please submit resumes to firstname.lastname@example.org