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IVD Principal Systems Integration Engineer
Peachtree Corners, GA, US
Scientific
Masters Degree
Full Time, Direct Hire
$1300,000-$150,000/year
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Peachtree Corners, GA, US
$1300,000-$150,000/year
Experienced (Non-Manager)
Full Time, Direct Hire
Medical Devices and Supplies
On-site
Scientific
Masters Degree
First Shift (Day)
Job details
Location: Norcross, GA (Relocation support available)
Employment Type: Direct Hire
Salary: $130,000 – $150,000 + 15% performance-based bonus
Schedule: Monday – Friday, 8:00 AM – 5:00 PM
Overview
We are proud to offer a Direct Hire opportunity for a Principal Systems Integration Engineer to join a growing team in Norcross, GA.
This role will lead system integration efforts across hardware, software, and assay components within a regulated IVD development environment. The ideal candidate will drive integration strategies, design verification activities, and troubleshooting efforts to support product development and system performance.
Key Responsibilities
- Develop and execute integration testing strategies for new hardware, software, assays, and products.
- Lead system integration activities for automated analyzers and related technologies.
- Design and execute experiments using DOE methodologies and analyze results using statistical tools.
- Perform advanced troubleshooting and debugging of automated systems.
- Conduct verification and validation (V&V) activities and ensure requirements and specifications are met.
- Develop and execute verification protocols, review results, and prepare summary reports.
- Perform traceability analysis between protocols and system requirements.
- Review and approve verification and validation documentation.
- Identify and manage technical risks, contributing to risk management activities such as SHA and FMEA.
- Support investigations into system issues and integration challenges.
- Represent the verification team on cross-functional product development teams.
- Collaborate with Systems Engineering, Quality, Regulatory, Assay Development, and other stakeholders.
Required Qualifications
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field, or equivalent experience.
- 4–10 years of related experience in system integration, development, or verification.
- Experience in IVD development (software, system, or assay integration focus).
- Strong troubleshooting, debugging, and analytical skills.
- Experience with verification/validation protocols and regulated product development environments.
Preferred Qualifications
- Experience working in regulated environments (IVD, medical device, diagnostics).
- Familiarity with statistical analysis tools and DOE methodology.
Skills & Capabilities
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving ability.
- Ability to work independently and exercise sound technical judgment.
- Comfortable operating in a fast-paced, collaborative development environment.
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