Principal Systems Integration Engineer - IVD

Kelly Services
Norcross, GA
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **Direct Hire** opportunity to work as a **Principal System Integration Engineer** located in **Norcross, GA** **Location:** Norcross, GA **Salary:** $100k-$130k **Schedule:** Monday - Friday, 8:00 AM - 5:00 PM 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 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 **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 \#P1 As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted 2025-11-20

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