Principal System Integration Engineer

Job Information

Number ICIMS-2025-8450 Job function R&D Job type Full-time Location T&T - Norcross - Norcross, Georgia United States Country United States Shift 1st

About the Position

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

The 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.

Responsibilities

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.

Qualifications

Minimum Knowledge & Experience required for the position:

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

If 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.