Lead and reach out throughout the organization to engage others, align, and deliver results in product development in GenMark's R&D team. Take on an active lead role and be responsible for developing numerous IVD products through FDA and CE mark approvals to commercialization.
Plan, direct and analyze the results from scientific experiments leading to the design, development and transfer to manufacturing of DNA array-based products for the detection, identification and quantification of nucleic acids and the diagnosis of diseases. Develop technical solutions to product design and performance issues.
• Take leadership, build trust, and serve as a key technical or project lead on one or multiple products while managing the development and commercialization of a new sample-to-answer platform and associated assay menu. Manage project plans according to timelines and deliverables, provide project cross functional review of project status.
• Design, perform and analyze experiments to design and characterize the performance of products relative to product performance and customer requirements.
• Align with Regulatory and Clinical departments to conduct and document the studies necessary for Class II and III IVD, i.e., 510(k) and PMA, worldwide regulatory submissions.
• Collaborate with Assay Development, Quality, Operations and other functions to demonstrate assay feasibility and product concepts; conduct assay development optimization on the automated platform; assay and system verification & validation; development of manufacturing processes, procedures, test methods and specifications; as well as transfer to sustaining organizations.
• Identify, invent, develop and implement effective solutions to technical issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research.
• Perform internal verification and validation of product performance.
• Design, characterize and validate test methods.
• Design and perform stability testing protocols.