Werfen
The Principal Systems Integration Engineer proactively leads and contributes to multiple moderate to complex projects and design changes in support of development and investigations. The selected candidate will be responsible for developmental activities, as well as design verification and validation related to products, assays, software and hardware.
Key Accountabilities
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 verfication 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
Networking/Key Relationships
Works closely with Systems Engineering, Quality, Regulatory, Assay Development, and occasionally Marketing and Clinical teams.
Location: Norcross, Georgia
Schedule: Monday through Friday (In-office daily)
Minimum Knowledge & Experience:
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 Science or Engineering Degree Preferred Skills & Capabilities:
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 Travel Requirements:
N/A
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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 Science or Engineering Degree Preferred Skills & Capabilities:
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 Travel Requirements:
N/A
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