Principal Systems Verification Engineer

Baxter International Inc.•Round Lake, IL

About The Position

As a part of the Infusion Therapies & Platforms (ITP) division, the Principal Systems Verification Engineer provides technical leadership to the System Verification team. This role 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, the engineer reviews and approves verification plans and methods and provides general direction to verification engineering staff. This role ensures that quality is built into the design during new product development, reports on progress to senior management, and contributes to the System Verification Engineering vision that aligns with the organization's vision and strategic plan. The engineer exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.

Requirements

Bachelor’s degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field.
5+ years of relevant industry experience.
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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Medical device industry experience is preferred.
Demonstrated experience with test automation preferred.

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.
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 for the team’s capabilities and accomplishments.
Create opportunities to automate testing and optimize test processes.
Leverage and enhance existing automation framework for system testing.
Participate and/or lead design reviews.
Guide the team in state-of-the-art V&V practices, QMS processes, and on applicable regulations/Standards, country-specific requirements.
Guide the team in investigations for identifying the root cause and drive action to prevent such issues from recurring.
Guide, mentor, and provide direction to junior verification and validation engineers.

Benefits

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits