Sr Project Leader

Overview

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. 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. 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 — The Sr Project Leader will lead cross-functional teams in the execution of Medical Device software and/or medical device hardware new product development projects. This role is responsible for coordinating all aspects of assigned projects, engaging appropriate functional partners to drive progress, resolve issues, and implement corrective actions as needed. The Project Leader establishes strong working relationships and credibility with team members and stakeholders while ensuring project deliverables meet schedule, cost, quality, and regulatory requirements.

This role applies established project management and Agile best practices within a regulated medical device environment. In addition, the Project Leader serves as a team facilitator and mentor, promoting effective execution, continuous improvement, and consistent adherence to development processes and quality system expectations.

• Lead cross-functional, multidisciplinary teams—potentially including globally distributed resources—in the development of Software and/or medical device hardware products.
• Plan and execute projects in alignment with New Product Development (NPD), Design Control, and Quality Management System requirements.
• Collaborate with software, systems, hardware engineering, quality, regulatory, manufacturing, and supply chain partners to develop and maintain integrated project plans.
• Facilitate tasks, responsibilities, and accountability to team members to achieve project and product objectives.
• Facilitate Agile Scrum processes for projects, including sprint planning, daily standups, sprint reviews, and retrospectives, while ensuring alignment with regulated development practices.
• Drive achievement of project milestones related to quality, time-to-market, cost, and regulatory compliance.
• Track and manage project budgets, including labor, operating expenses, and capital expenditures.
• Monitor project status, risks, and dependencies; apply appropriate change management practices to evaluate and address schedule, scope, or resource variances.
• Coordinate and support assessments of scope changes and their impact to quality, regulatory, cost, and schedule commitments.
• Communicate project status, risks, and escalation topics effectively to functional leaders and management.
• Contribute to team development by sharing best practices, supporting less-experienced team members, and fostering a culture of accountability and continuous improvement.

• Proven project management experience leading cross-functional teams in product development environments.
• Experience supporting software-intensive products, SaMD, and/or regulated medical device hardware development.
• Working knowledge of Agile Scrum principles and the ability to facilitate Scrum ceremonies within a regulated environment.
• Understanding of medical device development regulations and standards (e.g., FDA design controls, ISO 13485, IEC 62304, ISO 14971), or experience in other highly regulated industries.
• Demonstrated ability to influence team members, manage priorities, and drive execution against challenging timelines.
• Strong interpersonal and communication skills with the ability to engage diverse technical and functional stakeholders.
• Solid business acumen with experience managing project budgets, resources, and trade-off decisions.
• 4+ years of experience in project management or leading new product development teams, including coordination with external partners or suppliers.
• Bachelor’s degree in a technical discipline required.
• Experience in one or…