Job Description

System Verification Engineer (Medical Device Industry) - 36717

BB36717 San Jose, CA 95131 7+ Months

Work hours: 9-5pm onsite

3 Must haves on the resume: Hands on experience running flow cytometer instruments Hands on experience preparing biological samples Ability to follow directions in a user manual

Experience with running Flow Cytometer(s) is required. Please note position is in Systems Verification. Systems Verification experience is preferred. Ability to follow a protocol with minimal guidance.

The Systems Verification Engineer II participates in the definition, design, and execution of verification activities in the sustaining phase of the product development process for CLIENT Biosciences systems. This includes the design of test methods and test strategies, development and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions. The Systems Verification Engineer II role is a hands-on testing and problem-solving role, conducting experiments using flow cytometry and other CLIENTB systems.

The Systems Verification Engineer II generates analytical performance data used to support RUO and regulatory filings and is responsible for data archival, study binder prep, and writing study reports. The individual works closely with the System Verification study lead and the cross-functional product development team to ensure that the system design meets technical, customer, and regulatory agency requirements. Qualifications • 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. • Minimum 2 years experience in product development, instrumentation development, medical devices, test engineering, or other relevant industry experience • Hands on experience operating and troubleshooting flow cytometry analyzers and/or sorters, with knowledge of flow cytometry instrument platforms, applications and software, and assay panel development • Experience working within a regulated medical device industry with knowledge or experience in regulatory submissions • Able to work with human blood or blood products, with strong lab benchwork skills and meticulous sample handling and prep • Experience following signed protocols, standard operating procedures, and adhering to quality/ regulatory requirements • Basic knowledge of statistics with experience analyzing scientific data • Strong interpersonal skills with the ability to collaborate with others in a multi-disciplinary team • Excellent written and oral communication skills • Demonstrated success leading projects, with the ability to meet technical objectives and solve challenges under conditions of ambiguity and rapid change  

Company Description

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