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The Systems Verification Engineer II will work on BD flow cytometry products, ensuring product design meets requirements and customer needs.
Job Responsibility:
Work closely with Senior Systems Verification Scientist or Engineer and the product development team to ensure product design meets product requirements
Apply engineering, statistics, and scientific theory to measure and quantify performance of BD cell analysis products
Conduct experiments to assess system performance
May include the planning, writing and execution of system verification and validation protocols, analysis and interpretation of results, and communication of results
May be called upon to lead small to medium sized projects or initiatives, including generation of project plans, development of test strategies
May be responsible for translating product requirements to system verification test protocols
Engage in technical dialog with engineers and project stakeholders
Exercise independent judgment and apply systems thinking, problem solving, debugging, and troubleshooting
Operate within BD design control, quality, and safety requirements, and promote a safe working environment
Requirements:
Bachelor’s Degree in Biology, Immunology, Biomedical Engineering, or related fields
Minimum of 2 years experience in product development with knowledge of design control elements
Basic knowledge of the purpose of System Verification and Validation
Basic understanding on how to operate and trouble-shoot a Flow Cytometer Instrument
Ability to translate verbal and/or visual instructions into written instructions
Ability to quickly grasp the functionality and interdependencies of complex multidisciplinary systems
Ability to understand the broader impact of design features, testing methods, and test results
Apply systematic troubleshooting and debugging skills
Strong interpersonal skills
Excellent written and oral communication skills
Attention to detail
Proficient in data extraction, manipulation, interpretation, and presentation
Ability to prepare and process biological samples in a wet-lab Biosafety Level 2 Laboratory
Nice to have:
MS or Ph.D. degree in Biology, Immunology, Biomedical Engineering or in a related discipline
Strong knowledge of flow cytometry applications and assay panel development
Experience working within a regulated medical device industry
Experience in statistics, design of experiments, calculating sample sizes and estimating statistical power of study designs