Will lead a team of engineers in design and developing an innovative Point of care (POC), saliva based Rapid, Accurate and Affordable Diagnostic platform (Veralize®), which can quickly detect several infectious viral and bacterial diseases. Particular focus will be on COVID-19 rapid and accurate detection. Periodically report the progress to NIH RADx team (Monitoring and funding team) regarding developing Veralize as a Saliva based Rapid and accurate POC test. Perform R&D support on both current and new product research and developmental projects. This will include identifying requirements, proposing designs, developing prototypes, as well as performing design development, testing, and verification activities as required. Develop and maintain required quality procedures and controls to ensure that critical requirements are engineered into product development and manufacturing processes. Identify and mitigates risks. Ensure all documentation and systems are in place at launch in accordance with applicable regulations and specifications. Apply product knowledge, design control expertise to comply with quality and regulatory guidelines. Provide ideas about the engineering aspects of how genetic materials/living system works with the device to establish efficient working methods to project needs. Analyze the data and provide results along with the feedback to improve the device performance. Document activities by creating test protocols, technical reports, change reports, propose/publish research papers, and make suggestions based on the research findings. Maintain equipment by following preventative maintenance schedules, performing testing, and identifying, troubleshooting, and fixing malfunctions. Improve the performance of the equipment by researching the user-product interaction, consulting the users of the equipment, and developing modifications. Assist in developing an algorithm/application for automated data analysis and report. Provide guidance to the laboratory team on how to review and pick study protocols to meet project team objectives. Contribute to the team deliverables by ensuring proper identification and representation of user needs and communicating input to the engineering team in the product design and development. Participate in the development of design input documentation, and support the planning, development and conduct of design validation activities. Consult with the appropriate engineering team member to properly design experiments / create test setups, author test protocols, product development reports, verification, and validation activities.
Master’s degree or foreign equivalent in Biomedical Engineering or related field.
Please reference Job Number #771951 when sending resumes. Please mail resumes to: HR, 12-15 Molecular Diagnostics, Inc., 37 Panagrossi Circle, Suite L, East Haven, CT 06512.