Principal Systems Verification Engineer

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As a part of Infusion Therapies & Platforms (ITP) division, the Principal Systems Verification Engineer provides technical leadership to the System Verification team. Plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance. Based on significant process and technical expertise, reviews and approves verification plans and methods and provides general direction to verification engineering staff.

Ensures that quality is built into the design during new product development. Reports on the progress to senior management. Contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.

• Lead planning, development and execution of system verification deliverables (test plans, test protocols, test cases, test reports, studies) and provide technical direction to the team.
• Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, and related test systems).
• Develop and execute validation protocols, test plans, and reports in alignment with FDA, ISO, and equipment validation best practices.
• Perform IQ/OQ/PQ activities for lab equipment and ensure complete traceability from requirements through test execution.
• Contribute to the development and documentation of system requirements, systems architecture and design.
• Create best practices, process improvements and traceability to streamline testing between system, subsystem, and software verification.
• Implement configuration and change management through the complete product life cycle, including verification and validation deliverables.
• Actively communicate and advocate team’s capabilities and accomplishments.
• Create opportunities to automate testing and optimize test processes. Leverage and enhance existing automation framework for system testing.
• Participate in and/or lead design reviews. Guide the team in the state-of-the-art V&V practices, QMS processes and on the applicable regulations / Standards, country specific requirements.
• Guide the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
• Guide, mentor, and provide direction to junior verification and validation engineers.

• Bachelor’s degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field.
• 5+ years of relevant industry experience.
• Medical device industry experience is preferred.
• Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.
• Strong knowledge of ISO, FDA and other regulatory standards is essential.
• Knowledge of Design controls, lifecycle testing processes, MTBF analysis.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Ability to lead teams across multiple sites.
• Demonstrated experience with test automation preferred.

The estimated base salary for this position is $112,000 to $154,000 annually. The range reflects anticipated salary range for the position, which may be adjusted based on market data and other…