Principal System Integration Engineer - Transfusion ...

Job SummaryThe Principal Systems Integration Engineer proactively leads and contributes to multiple moderate to complex projects and design changes in support of development and investigations. Responsible for developmental activities as well as design verification and validation related to products, assays, software and hardware.Key AccountabilitiesIdentify 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 GDPWrite and execute moderately complex system related development and/or characterization protocols and data packages.Review and approve verfication and validation protocols and reports, as assignedManage 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 personnelAdditional task assigned as needed to support ongoing integration projects related to product, assay, software and hardwareNetworking/Key RelationshipsWorks closely with Systems Engineering, Quality, Regulatory, Assay Development, and occasionally Marketing and Clinical teams. Minimum Knowledge & Experience required for the position:Master's Degree (MA); or equivalent combination of education and experienceFour to ten years of related work experience.Experience in IVD development (software/system/assay focus) requiredScience or Engineering Degree PreferredSkills & 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 judgmentUnderstanding of technical content and the ability to communicate well with subject matter expert Works well with others in a collaborative, goal-driven environmentTravel Requirements:N/A

Created: 2025-10-13