Systems Verification Engineer 2

Job Description

This is a contract only position at BD Biosciences, a world leader in providing innovative tools for research and clinical laboratories. The Systems Verification Engineer II role involves contributing to a cross-disciplinary product development team, developing method improvements, and conducting experiments to assess the technical capability and performance of BD flow cytometry products.

Roles & Responsibilities

• Work closely with systems engineers and the product development team to enable the successful application and integration of hardware, reagents, and software in BD flow cytometry products.
• Apply engineering, statistics, and scientific theory to measure and quantify the performance of BD cell analysis products.
• Design, plan, and conduct experiments to assess the technical capability, feasibility, and performance of sub-systems and systems.
• Develop and execute formal protocols, analyze and interpret results, and communicate findings through written reports, design reviews, and interactive discussions.
• Pursue opportunities to facilitate more reliable and efficient verification and validation testing, such as automated test fixtures, simulation, and analysis capabilities.

Experience Required

• Desired: biochemical, software), Biostatistics, or Statistics
• Knowledge in systems engineering practices, experience in developing good requirements
• Experience in product development process and design control
• Experience working within a regulated medical device industry
• Knowledge of immunology and/or experience in assay development or application
• Experience in the cultivation, processing, or handling of cells
• Experience working in a Biosafety Level 2 Laboratory
• Knowledge of flow cytometry instrumentation and/or flow cytometry applications
• Knowledge or experience in FDA submissions
• Knowledge or experience interpreting CLSI guidelines
• 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

Skills & Certifications

• Strong interpersonal skills
• Excellent written and oral communication skills
• 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

Eligibilities & Qualifications

• Qualifications: For this position, flow cytometry experience is highly preferred but the other qualifications are a plus as well.
• Requires a minimum of a Bachelor’s Degree in an engineering, technology, or science field with a minimum of 2 years relevant experience or a combination of equivalent education and experience.
• Typically requires a minimum of 2 years experience in product development, instrumentation development, medical devices, test engineering, or other relevant industry experience
• Demonstrated knowledge and application of fundamental engineering concepts
• 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.