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Automation Engineer

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

Job Description:

Job Description Truvian Sciences is seeking a highly motivated Automation Engineer to join the Operations group. The new team member will play a major role in manufacturing development and transfer activities for a new blood diagnostic test. Cover letter and resume required for application.-- Apply through Linked in or send your cover letter and resume to -- Responsibilities: Design, build, and implement manufacturing automation for Truvian's Operations with a strategic emphasis on business needs and implementing "World Class" manufacturing that meets high quality standards and exceed customer expectations. Design, build, and implement automation equipment, fixtures and processes. Optimize production performance by employing proven risk assessment activities followed with V&V activities to optimize manufacturing processes and complete transfer following FDA guidelines Manage V&V protocols, execution and reporting to improve manufacturing processes. Develop and implement quality control procedures for reagents and processes Perform data analysis with advanced analytical and statistical tools. Perform root cause analysis and implement solutions to development and manufacturing issues. Communicate results and challenges with all appropriate departments Proven capability as a member of a product development team working to an aggressive schedule to launch Supervise the activities of team members -- Qualifications: Bachelor's degree in engineering plus 7 years of experience or equivalent Prior experience in IVD product development required. -- Track record of developing diagnostic tests or reagent kits in a regulated environment; knowledge of design control systems, experience assembling 510(k) and/or PMA documentation. -- Expertise in designing, building and implementing manufacturing automation Expertise in Solidworks, and LabView graphical programming 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 , Automation Engineer, Engineering , San Diego, California

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