Principal System Integration EngineerThe Principal System 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.ResponsibilitiesKey AccountabilitiesIdentify testing plans for integration of new hardware components, assays, software, and productsLead efforts developing strategies for assay, software, hardware integrationLead team to evaluate/ perform functional testing on new hardware/software/reagentEvaluate/ perform functional testing on new analyzers and/or new configurations to support product development activities and make decisions towards defining parametersDesign 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 systemsRepresent the Verification team on project core teamsPerform statistical and verification data analysis at an advanced levelDevelop Verification Protocols to assure Requirements and Specifications are fulfilledReview results of executed Protocols and write summary reports and provide conclusionsAnticipate the needs of the project and react to them accordingly without directionPerform traceability analysis of test protocol to RequirementMaintain adherence to PDP and GDPWrite and execute moderately complex system related development and/or characterization protocols and data packages.Review and approve verification and validation protocols and reports, as assignedManage execution of verification and validation protocolsReview technical risks and take appropriate actionMay assist in developing SHA and FMEA for Risk ManagementSupport moderately complex investigations of system issuesPresents, 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.QualificationsMinimum Knowledge & Experience required for the position:Master's Degree (MA); or equivalent combination of education and experienceFour to ten years of related work experienceExperience 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 expertWorks well with others in a collaborative, goal-driven environmentTravel Requirements:N/AClosingIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.Werfen is an Equal Opportunity employer and is committed to a diverse workplace.
Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.