Systems Verification Scientist II

Responsibilities

• Work closely with Senior Systems Verification Scientist or Engineer and the product development team to ensure product design meets product requirements on BD flow cytometry products.
• Apply engineering, statistics, and scientific theory to measure and quantify performance of BD cell analysis products.
• Conduct experiments to assess system performance, including planning, writing, and executing system verification and validation protocols, analyzing and interpreting results, and communicating findings through reports, design reviews, and discussions.
• Lead small to medium-sized projects or initiatives, generating project plans, developing test strategies that balance risk and business objectives.
• Translate product requirements into system verification test protocols.
• Exercise independent judgment, apply systems thinking, problem-solving, debugging, and troubleshooting to improve BD products or processes.
• Operate within BD design control, quality, and safety requirements, promoting a safe working environment.

Qualifications

• A minimum of a Bachelor’s Degree in Biology, Immunology, Biomedical Engineering, or related fields.
• A minimum of 2 years experience in product development with knowledge of design control elements.
• Basic knowledge of System Verification and Validation.
• Ability to operate and troubleshoot a Flow Cytometer Instrument.
• Ability to translate verbal and/or visual instructions into written instructions.
• Understanding of complex multidisciplinary systems, including lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.
• Ability to understand the broader impact of design features, testing methods, and test results.
• Systematic troubleshooting and debugging skills, practice in “systems thinking” problem solving approaches.
• Strong interpersonal skills.
• Excellent written and oral communication skills.
• Attention to detail.
• Proficient in data extraction, manipulation, interpretation, and presentation.
• Experience working in a Biosafety Level 2 Laboratory.
• Desired: MS or Ph.D. degree in Biology, Immunology, Biomedical Engineering or 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.