Scientist II, Systems Verification
San Jose, CA, USA | Becton Dickinson & Company
Job Description:110 people have viewed this job
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 and capable systems verification 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. The Scientist II is a hands-on testing and problem-solving role that will involve conducting experiments using flow cytometry.
The Systems Verification Scientist II will work closely with systems engineers and the product development team to enable product design meets product requirements on BD flow cytometry products, with emphasis on assessing the features to meet the needs of the customer.
He/She applies engineering, statistics, and scientific theory to measure and quantify performance of BD cell analysis products. He/She will design, plan, and conduct experiments to assess system performance. This includes the development and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact to the project and the customer through written reports, design reviews, and interactive discussions.
The Systems Verification Scientist II may be called upon to lead small to medium sized projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and directing small to medium sized teams.
He/She is comfortable asking questions, raising concerns, and engaging in technical dialog with engineers and project stakeholders.
He/She will regularly exercise independent judgment and apply systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve BD products or processes.
The individual shall operate within BD design control, quality, and safety requirements, and promote a safe working environment.
Education and Experience:
Minimum of a Bachelor’s Degree in life sciences, engineering, or technology field.
Minimum of 1 year experience in product development knowledge including planning, protocol writing, execution, processes, measures, etc.
Minimum of 1 year experience with flow cytometry applications and assay development.
Ability to quickly grasp the functionality and interdependencies of complex multidisciplinary systems, to include lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.
Apply systematic troubleshooting and debugging skills, practice in “systems thinking” problem solving approaches.
Ability to prepare and process biological samples in a wet-lab Biosafety Level 2 Laboratory.
Ability to apply careful attention to detail.
Ability to understand the broader impact of design features, testing methods, and test results to the user, customer, regulator, and to the marketability of the product.
Ability to critically evaluate proposed study designs.
Proficient in data extraction, manipulation, and interpretation.
Strong interpersonal skills.
Excellent written and oral communication skills.
Master's or Ph.D. degree in Cell Biology, Molecular Biology, Genetics, Biomedical Engineering or in a related discipline.
Experience in product development process and design control.
Experience working within a regulated medical device industry.
Knowledge or experience in FDA submissions.
Experience in statistics, design of experiments, calculating sample sizes and estimating statistical power of study designs.
Experience using MATLAB, SAS, JMP, R, MiniTab, or LabVIEW for scripting, data analysis, or automation.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
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