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Senior Consumables Engineer

Company: Truvian
Location: San Diego
Posted on: September 15, 2019

Job Description:

Job Description Truvian Sciences is seeking a highly motivated and passionate Senior Consumables Engineer to support R&D efforts focusing on IVD platform development. -- Responsibilities: -- -- -- -- -- Lead efforts driving design, development, and transfer of consumable components for an IVD system -- -- -- -- -- Formulate, develop, and update designs utilizing strong engineering fundamentals and tools and design for manufacturing principles -- -- -- -- -- Ensure component level selections and processes are amenable for high volume manufacturability and drive changes where needed -- -- -- -- -- Determine critical to quality specifications and ensure specifications are met using appropriate measurement methods -- -- -- -- -- Responsible for driving risk analysis and mitigations of consumable designs -- -- -- -- -- Work collaboratively with manufacturing, assay development, and external partners to develop and characterize processes and component selection -- -- -- -- -- Develop test plans and procedures for components, execute test plans, generate reports, and make conclusions and recommendations for next steps -- -- -- -- -- Lead cross-functional teams to determine design inputs, design outputs, and optimize design to meet required performance -- -- -- -- -- Develop scalable pilot line manufacturing processes -- -- -- -- -- Troubleshoot and debug fluidic, mechanical, and system issues -- -- -- -- -- Identify and implement design improvements -- -- -- -- -- Perform data analysis with advanced analytical and statistical tools (Prism, Excel, R, etc.) -- -- -- -- -- Keep a detailed laboratory notebook and summarize work in regular presentations -- -- -- -- -- Communicate results and challenges with colleagues and R&D management -- Qualifications: -- -- -- -- -- Bachelor's Degree in mechanical engineering, biomedical engineering, or equivalent with 10+ years of IVD experience or an MS degree in Mechanical engineering, biomedical engineering, or equivalent with 8+ years of IVD experience -- -- -- -- -- Prior experience in medical device or IVD product development required -- -- -- -- -- Experience in developing high volume, low cost consumables using a variety of manufacturing methods such as lamination, injection molding, 3D printing, and machining -- -- -- -- -- Experience in leading work on complex problems that require cross-functional solutions and collaboration -- -- -- -- -- Experience in delivering an IVD product from research to market -- -- -- -- -- Strong background in product design and development -- -- -- -- -- Strong understanding of the fundamentals of design controls -- -- -- -- -- Proficient with Solidworks or other CAD software -- -- -- -- -- Very strong analytical and problem-solving skills; organized and efficient -- -- -- -- -- Proven interpersonal, communication, and presentation skills; excellent time management skills -- -- -- -- -- Able to excel in collaborative, fast-paced, and evolving start up environment; able to manage competing priorities -- -- -- -- -- Superb attention to detail; produces work of exceptional quality and accuracy -- -- -- -- -- Ability to proactively identify issues and address with solutions-oriented approach

Keywords: Truvian, San Diego , Senior Consumables Engineer, Engineering , San Diego, California

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