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Director Of System Engineering

Employer
binx health
Location
UK
Salary
Competitive
Closing date
27 Jul 2021

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Sector
Engineering
Contract Type
Permanent
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Job Details

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 for 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.

The Position

We are looking for a Director of Systems Engineering to lead engineering technical insight within the business, maintain an overview of all technical aspects of the binx io POC platform and cartridges, and develop engineering solutions for the existing product range and for new products. Additionally, we are looking for the Director of Systems Engineering 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, prepare documents for and support regulatory submissions and mentor other engineers both in technical and professional development.

Responsibilities

  • Direct the maintenance and overview of all technical aspects of the io platform and cartridges including firmware, software and system cartridge interfaces
  • Direct the assessment of existing system architecture and recommend improvements and enhancements
  • Investigate and develop solutions and new opportunities in the io and cartridge platform
  • Drive system-wide troubleshooting and root cause analysis investigation across the engineering, manufacturing and R&D teams
  • Provide technical expertise throughout the company
  • Drive the maintenance of the instrument DHF
  • Provide technical expertise at the system level to align technical teams on hardware, and supply components and drive collaboration and excellence across all areas
  • Assess existing system architecture and recommend improvements, enhancements
  • Drive, direct and lead strategy for new hardware developments and a pipeline for the io and cartridge platform
  • Define scope of verification testing and provide key support for verification and validation activities
  • Prepare documents for and support regulatory submissions
  • Investigate and develop solutions and new opportunities in the io and cartridge platform
  • Direct strategies for monitoring reliability and performance in the io platform
  • Steer requirements for software developments on the io platform
  • Support 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.


Qualifications

  • 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, focussed on PCR and sample preparation
  • Strong skills in 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


Additional Information



Employee may be required to lift routine office supplies and use office equipment. 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, Inc. is proud to be an equal opportunity workplace. All qualified applicants will receive consideration for employment without regard to and will not be discriminated against based on age, race, gender, color, religion, national origin, sexual orientation, gender identity, veteran status, disability or any other protected category.
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