Systems Engineer

at CorTech LLC
Location San Jose
Date Posted January 14, 2022
Category Engineering
Job Type Not Specified

Description

For many roles at this client, assignment is contingent upon the Employer of Record's receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law.

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.

Please include the responses to these questions with each submittal. The HM will discuss during our call in the next few minutes.

1. What is your motivation for applying to this position?
2. What is your experience with diagnostic instrumentation or complex systems that include optics, assays, electro-mechanical components, and software?
3. What has been your experience working in a lab environment testing and/or verifying systems?
4. Describe your work experience in product development.
5. Describe the basic operations of a flow cytometry instrument.

Responsibilities
- The Systems Verification Engineer II will 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, with emphasis on assessing the 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 conduct experiments to assess system performance. This may include the planning, writing and execution of system verification and validation protocols, analysis and interpretation of results, and communication of results and their impact to the project through written reports, design reviews, and interactive discussions.
- The Systems Verification Engineer II may be called upon to lead small to medium sized projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives
- The Systems Verification Engineer II may be responsible for translating product requirements to system verification test protocols.
- He/She is comfortable asking questions, raising concerns, and engaging in technical dialog with engineers and project stakeholders.
- He/She will regularly exercise independent judgment and apply systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve BD products or processes.
- The individual shall operate within BD design control, quality, and safety requirements, and promote a safe working environment.

Qualifications
The successful candidate will possess:

• 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 the purpose of System Verification and Validation
• Basic understanding on how to operator 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, to include 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 in the context of the user, customer, regulatory guidelines, and to the marketability of the product.
• Apply 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
• Ability to prepare and process biological samples in a wet-lab Biosafety Level 2 Laboratory

Desired:
• 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.

"For many roles at this client, assignment is contingent upon the Employer of Record's receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law."

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