Principal Systems Verification Engineer

Baxter; Round Lake Beach (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical and dental benefits

401(k) retirement plan

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter is seeking a Principal Systems Verification Engineer in the Infusion Therapies & Platforms division in the United States. You will plan and lead system verification activities, ensuring alignment with FDA/ISO standards and driving quality in new product development.

You will mentor engineers, enhance automation, and collaborate across sites to deliver safe medical devices while advancing verification and validation practices. This role offers competitive pay and comprehensive benefits.

Qualifications

• Bachelor's degree in a relevant engineering or science field.
• 5+ years of relevant industry experience.
• Medical device industry experience preferred.
• Strong organization and communication skills with technical and non-technical stakeholders.
• Solid knowledge of ISO, FDA and other regulatory standards.

Responsibilities

• Lead planning, development and execution of system verification deliverables and provide technical direction to the team.
• Lead validation efforts for laboratory equipment supporting infusion system testing.
• Develop and execute validation protocols, test plans, and reports per FDA, ISO and equipment validation best practices.
• Perform IQ/OQ/PQ activities for lab equipment with complete traceability from requirements to testing.
• Contribute to system requirements, architecture and design documentation.
• Create best practices and traceability to streamline testing across system, subsystem and software verification.
• Implement configuration and change management through the product life cycle including verification and validation deliverables.
• Communicate and advocate the team’s capabilities and accomplishments.
• Create opportunities to automate testing and enhance existing automation framework for system testing.
• Participate in design reviews and guide teams in verification/validation practices and regulatory standards.
• Guide investigations to identify root causes and prevent recurrence.
• Mentor junior verification and validation engineers.

Skills

Strong communication

Leadership across sites

Test automation experience

Project planning

Education

Bachelor's degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your Role at Baxter

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. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.

What you'll be doing

• 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.
• 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.

What you will bring

• 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.

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 the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

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.

#LI-OM1

US Benefits at Baxter (except for Puerto Rico)

Baxter offers comprehensive compensation and benefits packages for eligible roles.

• medical and dental coverage that start on day one
• basic life insurance coverage
• accident insurance coverage
• short-term disability insurance coverage
• long-term disability insurance coverage
• 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

Join us and enjoy the competitive compensation and benefits we offer to our employees.

For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, let us know the nature of your request along with your contact information.