Job Description

Job Title: Principal Systems Integration Engineer

Job Summary: The Principal Systems Integration Engineer will lead and contribute to a variety of complex projects, ensuring seamless integration of hardware, software, assays, and other product components. The role encompasses the development, verification, and validation of designs to enhance functionality, troubleshoot issues, and support innovation in IVD systems.

Responsibilities:

• Develop and implement comprehensive testing plans for integrating hardware, software, and assay components.
• Spearhead strategies for the effective integration of diagnostic tools and technologies.
• Oversee and conduct functional evaluations of new analyzers, configurations, and system components, ensuring alignment with design parameters.
• Design and execute experiments using Design of Experiments (DOE) methodologies, applying advanced statistical tools to interpret results and inform design refinements.
• Diagnose and resolve complex system-level issues to maintain optimal functionality.
• Represent the Verification team in core project discussions and cross-functional collaborations.
• Analyze verification data to ensure it meets specifications and document findings in detailed reports.
• Develop and execute system development protocols and manage data analysis packages for moderately complex projects.
• Perform traceability analyses to ensure requirements are adequately addressed by testing protocols.
• Evaluate technical risks and recommend appropriate mitigation strategies.
• Contribute to risk management activities, including System Hazard Analyses (SHA) and Failure Modes and Effects Analyses (FMEA).
• Support investigations into system performance issues and recommend corrective actions.
• Communicate findings effectively across multidisciplinary teams, including engineering, quality, and regulatory groups.

Key Relationships: Collaborate with cross-functional teams including Systems Engineering, Quality Assurance, Regulatory Affairs, Assay Development, and occasionally Marketing and Clinical Operations.

Qualifications:

• A Master’s degree in a related field, or equivalent education and experience.
• 4 to 10 years of relevant experience, preferably in In Vitro Diagnostics (IVD) system or software development.
• 4-10 years of IVDR experience.
• Background in science or engineering is strongly preferred.

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