Principal Systems Integration Engineer - IVD jobs in United States
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Kelly Science, Engineering, Technology & Telecom · 4 hours ago

Principal Systems Integration Engineer - IVD

Kelly Science, Engineering, Technology & Telecom is offering a Direct Hire opportunity for a Principal Systems Integration Engineer located in Norcross, GA. The role involves leading and contributing to various complex projects, focusing on integration of hardware, software, and assays, as well as design verification and validation activities.

Staffing & Recruiting
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Hiring Manager
Jacqueline S.
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Responsibilities

Identify testing plans for integration of new hardware components, assays, software, and products
Lead efforts developing strategies for assay, software, hardware integration
Lead team to evaluate/ perform functional testing on new hardware/software/reagent
Evaluate/ perform functional testing on new analyzers and/or new configurations to support product development activities and make decisions towards defining parameters
Design experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements
Perform advanced troubleshooting on the automated systems
Represent the Verification team on project core teams
Perform statistical and verification data analysis at an advanced level
Develop Verification Protocols to assure Requirements and Specifications are fulfilled
Review results of executed Protocols and write summary reports and provide conclusions
Anticipate the needs of the project and react to them accordingly without direction
Perform traceability analysis of test protocol to Requirement
Maintain adherence to PDP and GDP
Write and execute moderately complex system related development and/or characterization protocols and data packages
Review and approve verification and validation protocols and reports, as assigned
Manage execution of verification and validation protocols
Review technical risks and take appropriate action
May assist in developing SHA and FMEA for Risk Management
Support moderately complex investigations of system issues
Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel
Additional task assigned as needed to support ongoing integration projects related to product, assay, software and hardware

Qualification

IVD developmentStatistical analysisTroubleshootingVerification protocolsCommunication skills

Required

Master's Degree (MA); or equivalent combination of education and experience
Four to ten years of related work experience
Experience in IVD development (software/system/assay focus) required

Preferred

Science or Engineering Degree Preferred
Excellent written and verbal communication skills
Excellent analysis, troubleshooting, and debugging skills
Ability to perform in a fast-paced, agile environment
Ability to operate independently and exercise good judgment
Understanding of technical content and the ability to communicate well with subject matter expert
Works well with others in a collaborative, goal-driven environment

Benefits

15% performance based bonus potential

Company

Kelly Science, Engineering, Technology & Telecom

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Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.

Funding

Current Stage
Late Stage

Leadership Team

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Linda Stuit
Senior Vice President, Engineering Specialty
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Company data provided by crunchbase