Full Job Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Principal Engineer, System Verification & Validation-R&D - Medical Devices
Round Lake, IL
About Baxter’s Global Medication Delivery (MD) Business Unit
Our team is dedicated to creating value from the prescription to the safe delivery of medication around the world and across the patient continuum of care.
MD has a vast portfolio of products including the IV solutions portfolio, infusion systems including Elastomerics, IV sets and access, pharmacy tools, ICNet and DoseEdge – all aimed at creating new, innovative value for customers and patients.
Together with strong talent, globally diverse teams and an inclusive culture, we believe that Medication Delivery is uniquely positioned to deliver value to our hospital customers and their patients, from prescription to administration.
Technical leadership for the MD System Verification & Validation (V&V) team
Great opportunity for those inside/outside of Healthcare, e.g. device industries, communication networks, etc.
As Principal Engineer, lead technical team members in application of standard system engineering principles, methods, and techniques to resolve difficult problems focused on system verification. Plans/leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance.
Based on significant process/technical expertise, reviews/approves verification plans/methods, provides general direction to Verification engineering staff
Assures that quality is built into the design during new product development. Contributes to System V&V Engineering vision that aligns with the organization's vision/strategic plan.
Utilizes solid understanding of engineering theory and best-practices to manage complex projects/programs within quality, time and budget
Provides direction to technical team members accountable for system verification engineering activities
Creativity/innovation in completing divisional/cross-functional/business unit goals/objectives
Lead planning/development/execution of system verification/validation deliverables, e.g. test plans, test protocols, test cases, test reports and studies) and provide technical direction to the team.
Engage in test planning during design/ development phases and is key contributor to the development/documentation of system requirements, systems architecture and design.
Create best practices/process improvements/traceability to streamline testing between system verification, subsystem and software verification.
Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
Implement configuration/change management through complete product life cycle, including V&V deliverables
Create opportunities to automate testing/optimize test processes. Leverage/enhance exiting automation framework for system testing.
Participates and/or leads design reviews. Guides team in the state of art V&V practices, QMS processes and on the applicable regulations / Standards, country specific requirements.
Assures compliance to the product development process/Quality System requirements.
Assures good documentation practices are followed in the V&V process.
Bachelor’s Degree in Electrical, Computer Science or equivalent, MS preferred, with 5+ years of relevant industry experience.
Requires strong organization/communication skills, with demonstrated results interfacing with both leadership and technical/non-technical team members
Demonstrated experience with FDA and other regulatory standards
Demonstrated experience with Design controls, lifecycle testing processes, MTBF analysis
Demonstrated results in team leadership, development and mentoring, and leading a team across multiple sites
Familiarity with HL7 interoperability standards preferred.
Demonstrated experience with test automation preferred.
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.
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Pay Transparency Policy
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, please click on the link here and let us know the nature of your request along with your contact information.