Senior PM, Infusion Systems (Cross-Functional)

Baxter International Inc.

Town of Round Lake (WI)

Hybrid

USD 150,000 - 190,000

Full time

12 days ago

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Benefits offered by this job

Flexible onsite days

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Job summary

Baxter International Inc. is seeking a Senior Program Manager to lead cross-functional infusion pump programs, translating product, customer, quality, regulatory, and business priorities into integrated execution plans.

You will drive timely decisions across global teams in a highly regulated medical device environment. The role involves partnering with R&D, Systems Engineering, Software, Quality, Regulatory, Manufacturing, Supply Chain, Service, Commercial, Finance, and external partners to

Qualifications

Bachelor’s degree in Engineering, Computer Science, Life Sciences, Business, or related field; 10+ years of PM experience or a Master’s with 8+ years in regulated industries.
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/software development, verification/validation, design controls, and change management.
Demonstrated track record of delivering complex programs within scope, schedule, budget, quality, and regulatory requirements.
Expertise in program planning/execution, 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 standards.
Excellent leadership, communication, and stakeholder management skills, with ability to influence across global matrix organizations; PMP, PgMP, or equivalent preferred.

Responsibilities

Lead complex infusion pump programs across the full product lifecycle, including new product development, software/firmware releases, sustaining engineering, compliance, cost improvement, and obsolescence initiatives.
Own program scope, timelines, budgets, resources, quality, and risk management, ensuring 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 decisions.
Communicate program status, milestones, budgets, risk, 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.