Infusion Systems Program Leader

Zvh; United States; On-site; USD 152,000 - 209,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off 20-35 days

Job summary

Baxter is seeking a Senior Program Manager to lead infusion pump programs, driving delivery across the full product lifecycle in a highly regulated medical device environment.

You will partner with R&D, Systems Engineering, Software, Quality, Regulatory, Manufacturing, Supply Chain, Service, Commercial, Finance, and external partners to meet program commitments. Strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, Business, or a related field with 10+ years of relevant experience.
• 6+ years of progressive project or program management experience leading complex, cross-functional programs in regulated industries.
• Proven experience with electromechanical medical devices, infusion systems, connected products, or other safety-critical technologies.
• Strong understanding of medical device development and lifecycle processes, including systems engineering, hardware and software development, verification and validation, design controls, and change management.
• Demonstrated track record of successfully delivering complex programs within scope, schedule, budget, quality, and regulatory requirements.
• Expertise in program planning and execution, including critical path management, financial management, risk mitigation, structured problem solving, and data-driven decision making.
• Working knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62304, and applicable medical device quality and regulatory standards.
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence across global matrix organizations; PMP, PgMP, or equivalent certification preferred.

Responsibilities

• Lead complex infusion pump programs across the full product lifecycle, including new product development, software and firmware releases, sustaining engineering, compliance, cost improvement, and product obsolescence initiatives.
• Own program scope, timelines, budgets, resources, quality, and risk management, ensuring successful delivery from initiation through implementation and closeout.
• Direct cross-functional teams and drive alignment across engineering, manufacturing, regulatory, quality, commercial, service, and supply chain functions to achieve program objectives.
• Develop and maintain integrated program plans, managing dependencies, critical paths, milestones, resource allocation, and launch readiness activities.
• Establish program governance processes, lead reviews and decision forums, and provide timely escalation and resolution of complex program issues and risks.
• Identify, assess, and mitigate technical, regulatory, quality, manufacturing, supplier, cybersecurity, and commercial risks while driving structured problem-solving and data-based decision making.
• Communicate program status, milestones, budgets, risks, and recovery plans to senior leadership and stakeholders, influencing decisions and securing resources without direct authority.
• Ensure compliance with design controls, quality systems, and regulatory requirements while supporting product roadmaps, continuous improvement initiatives, PMO best practices, and program management capability development.

Skills

Program leadership

Cross-functional collaboration

Regulatory awareness

Data-driven decisions

Stakeholder management

Communication

Problem solving

Leadership

Education

Bachelor's degree in Engineering/CS/Life Sciences/Business

Master's degree (8+ years experience)

Job description

Baxter is seeking a Senior Program Manager to lead infusion pump programs, driving delivery across the full product lifecycle in a highly regulated medical device environment.

You will partner with R&D, Systems Engineering, Software, Quality, Regulatory, Manufacturing, Supply Chain, Service, Commercial, Finance, and external partners to meet program commitments. Strong leadership and regulatory knowledge are essential.