Director Systems Engineering, infusion systems, medical fluid management (On-Site Round Lake, IL – RELOCATION Assistance Considered)

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. 

Your Role at Baxter:

As the Director Systems Engineering, Infusion Systems, you will lead the development and delivery of Baxter Healthcare's Infusions Systems, championing the voice of the customer and driving innovation, while ensuring safety and efficiency.  In this critical, new role you will lead all aspects of the entire product lifecycle from requirements definition to verification, ensuring that our products meet the highest standards of safety, reliability, and innovation.  

What You’ll Be Doing:

•          Lead and develop global systems engineering teams based in Round Lake, IL and Bangalore, India, and Medina, NY

•          Create, effectively communicate and deploy the strategy for the team that aligns with the overall systems organization strategic plan

•          Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms

•          Lead systems design validation across all platforms

•          Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives

•          Collaborate to ensure alignment and traceability of requirements throughout the product development process

•          Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks

•          Lead resource demand planning, allocation, and actuals

•          Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement

•          Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards

•          Ensure robust verification and validation processes are in place to guarantee product quality and compliance with medical device regulations

•          Maintain effective communication with internal and external stakeholders, including regulatory bodies, to ensure product compliance and market readiness

•          Contribute to innovation by identifying opportunities to improve the infusion system

•          Ensure that new learnings from one platform are considered and applied correctly across the entire infusion system platform

•          Oversee the generation of all systems deliverables, including system requirements, design documents, test plans, and user documentation

•          Advance verification capabilities, lab, and automation, ensuring they meet the defined requirements and are of high quality

•          Provide leadership for resource staffing and project execution for the team with proactive management of technical and project risk to ensure delivery of business commitments

•          Identify and manage product development risks related to system development, regulatory non-compliance, and project delays

•          Represent the systems engineering team in meetings, presentations, and other communications with internal and external stakeholders

•          Foster a collaborative work environment with strong working relationships within and across teams, functions, and with strategic external partners

•          Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities

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