Systems Verification Engineer 2

Roles & Responsibilities

Job Description:

At Client 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, Client Biosciences is seeking a passionate and capable systems test engineer 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 Systems Verification and Validation Engineer II is a hands-on testing and problem-solving role that will involve conducting experiments using flow cytometry.

Responsibilities:

The Systems Verification Engineer II will work closely with systems engineers and the product development team to enable the successful application and integration of hardware, reagents, and software in Client flow cytometry products, with emphasis on assessing the suitability of design architectures and features to meet the needs of the customer. He/She applies engineering, statistics, and scientific theory to measure and quantify performance of Client cell analysis products. He/She will design, plan, and conduct experiments to assess the technical capability, feasibility, and performance of sub-systems and systems. 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 Engineer II identifies and pursues opportunities to facilitate more reliable and efficient verification and verification testing, such as automated test fixtures, simulation and analysis capabilities.

Experience Required

• 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

Desired:
• 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

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.
• Apply systematic troubleshooting and debugging skills, practice in ”systems thinking“ problem solving approaches
• 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

Keywords:

Clinical, Verification, research, Lab, Biosafety Level 2, MiniTab, LabVIEW, MATLAB, FDA submissions, medical device, design control, flow cytometry, product development, systems engineering