Senior Scientist, R&D Operations

Title: Senior Scientist, R&D OperationsLocation: Sunnyvale, CA- 100% onsiteShift: M-F, standard working hoursPay: $50-$65/hrOverview:The Senior Scientist is responsible for on-market product support in terms of post-market activities, to evaluate the performance of products against country-specific requirements and documentation for registration that drive significant impact to the organization.This position relies heavily on experiences gained in design and development of molecular diagnostic products and provides hands-on experiences in molecular point of care tests in an FDA-QSR and ISO13485 compliant organization.This position is part of the R&D, Global Market Expansion group.Responsibilities:Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation.Solve complex problems and work in a cross-functional team-based environment.Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals.Research, initiate and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report generation.Requirements:Proficiency in microbiology and molecular lab techniques, with comprehensive training in blood-borne pathogen related lab safety and chemical lab safety.Experience with designing and executing experiments with clinical specimens to verify assay performance.Demonstrated ability to interpret federal/state/international regulations as they apply to technical documentation.Ability to prepare high quality technical documents on product design verification and validation for regulatory submissions.Preferred Requirements, plus not required:Experienced in Design of Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies.Education and Experience Requirements:Bachelor’s degree in related field (e.g., Microbiology, Molecular Biology, Chemistry, Biology and Genetics) with 8+ years of relevant industrial experience ORMaster’s degree in related field with 5+ years of related work experience ORDoctoral degree in related field with 3+ years of related work experience.9430835 Sunnyvale, CA, US Scientific Bachelors Degree Full Time, Temporary Experienced (Non-Manager) On-site Medical Devices and Supplies First Shift (Day)