# Job Description Summary
# Job Description
At BD Biosciences, our purpose is to help all people live healthy lives\. We are a world leader bringing innovative tools to research and clinical laboratories in basic research, drug discovery and development, biopharmaceutical production and disease management\. We develop technology that enables faster diagnosis and better clinical outcomes\.
To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate, creative, and highly skilled Systems Verification and Validation Staff Scientist to contribute to a cross\-disciplinary product development team, and to develop method improvements that drive greater efficiency and productivity of the Systems Verification and Validation team\.
**Responsibilities:**
The Systems Verification and Validation \(SVV\) Staff Scientist leads large, multi\-project teams in the definition, design, and execution of SVV activities throughout all phases of the product development process for BD Biosciences cellular analysis systems\. This includes the generation of project plans, development of test strategies that balance risk and business objectives, creation and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions\. The Staff Scientist supports the successful application of new technologies and ensures that the system design meets technical, customer, and regulatory agency requirements\. He/She functions with a high degree of independence and applies systems thinking, creative problem solving, and troubleshooting to generate innovative ideas to improve BD products or processes\.
As a highly trusted internal subject matter expert in Cell Biology, Immunology, Molecular Biology or related scientific field, the Staff Scientist serves as a technical lead on product development teams\. The individual exercises influence across functions and contributes to cross\-functional effectiveness performing activities such as the development of technical justifications to support regulatory submissions and writing scientific materials for marketing\. The individual maintains up\-to\-date knowledge of customer workflows, technological advancements in flow cytometry and the competitive landscape and will be called upon to represent the voice of the customer to developers as well as translates customer needs into product requirements\. The Staff Scientist provides expert input to senior management on strategic and functional decisions, drives internal process efficiencies, and champions new ideas which contribute to the development of new principles and concepts\.
**Minimum Qualifications:**
+ Typically requires a minimum of a Bachelor’s Degree in Immunology, Cell Biology, or Clinical Laboratory Science with a minimum of 8 years relevant experience or a combination of equivalent education and experience\.
+ Extensive hands on experience operating and troubleshooting flow cytometry analyzers and/or sorters, with knowledge of flow cytometry instrument platforms, applications and software, multi\-color assay panel development and customer workflows
+ Significant experience designing, executing, and interpreting the results of complex scientific experiments or feasibility studies
+ Proven ability to critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power
+ Technical proficiency with data analysis software such as Prism or Minitab
+ Strong interpersonal skills with a proven ability to collaborate with others in multi\-disciplinary team settings, influence decision making, and build group consensus
+ Excellent written and oral communication skills
+ Demonstrated success leading large projects, with the ability to meet technical objectives and solve complex challenges under conditions of ambiguity and rapid change
+ Experience managing timelines, budgets, and resources using project management tools such as TFS, Microsoft Project, PERT charts, and Gantt charts
+ Experience handling and processing infectious blood samples in a Biosafety Level 2 laboratory using universal precautions
**Desired:**
+ \(Preferred\) PhD degree in Immunology, Cell Biology or in a related scientific discipline
+ Strong knowledge of HIV, leukemia, lymphoma, hematology, and/or cancer biology
+ Experience communicating voice of customer and user needs through workflow diagrams , requirement generation, usability reports, or other related methods
+ Experience with genomics instrumentation, applications, and customer workflows
+ Experience in human factors or usability engineering principles or studies
+ Experience working within a regulated medical device industry with knowledge or experience in FDA submissions
+ Familiar with accreditation and guiding agencies for the clinical laboratory including CAP, CLIA, and CLSI, including experience in audits conducted by accrediting bodies
# Primary Work LocationUSA CA \- San Jose
# Additional Locations
# Work Shift