Job Title - Systems Verification Engineer II

Location - San Jose, CA

Duration – 5+ Months Contract

Total Hours/week - 40.00
1st Shift

Work hours: 9am-5pm

3 Must haves on the resume:
1. 1-2 years industry experience in a system verification and validation role within a R&D organization OR 1-2 years industry experience running Flow Cytometers in a product development environment
2. Ability to write and follow a protocol with minimal guidance.
3. Applicants must have experience working in the lab with blood samples.
*Note: Due to COVID-19, this position will be working in the office to run experiments as needed and will work from home when lab work is not required until further notice by BD.
 

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, BD 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 BD 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 BD 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.

Qualifications
The successful candidate will possess:
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

Desired:

(Preferred) 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