Senior Systems Verification Engineer

Baxter International Inc.•Round Lake, IL

1d•Onsite

About The Position

As a part of the Infusion Therapies & Platforms (ITP) division, the Senior Systems Verification Engineer contributes to the System Verification Engineering vision that aligns with the organization's vision and strategic plan. This role uses a proven understanding of engineering theory and best-practice in a variety of fields to lead sophisticated projects or programs within boundaries of quality, time, and budget. The engineer will exhibit creativity and innovation in completing divisional and cross-functional/business unit goals and objectives. They will contribute to plans and lead project assignments in the evaluation, selection, and adaptation of various techniques, procedures, and criteria with minimal mentorship. This role ensures that quality is built into the design during new product development.

Requirements

Bachelor’s Degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent
3+ years of relevant industry experience.
Proven organization skills and ability to collaborate with both technical and non-technical personnel.
Solid understanding of ISO and/or FDA and other regulatory standards.
Knowledge of Design controls, Lifecycle testing processes, MTBF analysis.
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.

Responsibilities

Contribute to the planning, development, and execution of system verification deliverables (test plans, test protocols, test cases, test reports, studies).
Engage in test planning during design and development phases.
Contribute to the 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.
Ensure appropriate traceability between system, subsystem, and software verification.
Manage the integration of deliverables from subsystem teams, multi-functional teams (risk management, compliance, etc.), and external partners.
Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory).
Implement configuration and change management through the complete product life-cycle.
Build process improvements to streamline testing between system verification, subsystem, and software verification.
Ensure all program achievements in support of all phases of the product development lifecycle are completed on time, with appropriate quality, and in compliance with relevant laboratory standards and regulations.
Participate and/or lead design reviews.

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