System Engineer I
Pleasanton , CA 94588
Posted 3 weeks ago
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SUMMARY:The position of System Engineer plays a key rolein the development and validation of instrument systems for running molecular diagnostic tests for the In Vitro Diagnostics (IVD) global market place.We are seeking candidates with experience in automating assay processes on instrumentation that perform liquid handling, sample processing, and optical signal analysis. Experience in product development, systems engineering, and verifying system performance by testing is required. Expertise in the areas of microfluidics, optical subsystems, robotic handling, and integration of biochemical reagents onto instruments is required. Experience in medical device software development and validation is strongly desired.Knowledge and experience with PCR assays and associated data analysis methods is a plus. Training or experience in the use of industry standard reliability tools, process capability analysis, and use of computers and IT systems is also desired.Candidates with additional knowledge and experience in the processes associated with IVD product development would be prioritized. Such processes include requirements management, risk analysis, verification and validation, and usability engineering.JustificationRecruiting a position approved by theheadcount review teamJob DescriptionMajor Job Functions and Contributions* Participate in technical projects per the Life Cycle Management and product development processes. * Develop automated processes for running molecular-based diagnostic assays on instrumentation that perform liquid handling, sample processing, and optical signal analysis. * Carry out tasks as necessary to run test campaigns to verify requirements and design specifications, and ensure conformance to intended use of products. * Collect, analyze, and develop report packages to support system verification and validations, and compile content for regulatory submissions. * Conduct reliability analysis, testability analysis, software reliability, fault tolerance, and system stress analysis on instrument systems that run diagnostic assays. * Participate on project team through the steps of design, development, and validation.General Skills, Abilities, Attributes* Exceptional people skills, strong communication, flexible personality, able to work independently and as part of a team. * Strong skills in writing technical reports and verbally communicating technical content in oral presentations * Excellent problem solving skills and ability to work with minimal directionMinimum Requirements* B.S. or M.S. in Engineering, Physical, and/or Biological Sciences, or related field.