Werfen North America · 2 days ago
Principal System Integration Engineer - Transfusion and Transplant
Norcross, GA
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expWerfen North America is seeking a Principal Systems Integration Engineer to lead and contribute to multiple complex projects in support of development and investigations. This role involves managing developmental activities, design verification, and validation related to products, assays, software, and hardware.
Health CareManufacturing
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
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
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
Preferred
Science or Engineering Degree Preferred
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
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