Principal Systems Verification Engineer,

About the role

This is where your work saves lives. 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.

Responsibilities

• 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.
• Create best practices, process improvements, and traceability to streamline testing between system, subsystem, and software verification.
• Implementing configuration and change management through the complete product life cycle, including verification and validation deliverables.
• Actively communicates and advocates team’s capabilities and accomplishments.
• Create opportunities to automate testing and optimize test processes.
• Leverage and enhance existing automation framework for system testing.
• Participates and/or leads design reviews.
• Guides the team in the state of art V&V practices, QMS processes, and on the applicable regulations / Standards, country specific requirements.
• Guides 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.

Requirements

• 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.

Qualifications

• Required:
• 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.
• Required Knowledge and Skills:
• 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.

Skills

• Strong knowledge of ISO, FDA and other regulatory standards.
• 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.

Benefits

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Pay

The estimated base salary for this position is $112,000 to $154,000 annually.

Schedule

N/A