Senior Systems Engineer, Product Design Owner

Baxter International Inc.; Skaneateles Falls (NY); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Employee stock purchase plan (ESPP)

Job summary

Baxter International Inc. is seeking a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D.

You will provide technical leadership for Baxter's Exam Diagnostics portfolio, serving as the design authority across the product lifecycle and coordinating cross-functional decision-making to ensure quality, compliance, and business continuity. The role requires strong systems thinking and risk-based decision making, with the ability to influence a global organization.

Qualifications

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Computer, Software Engineering, or a related technical field.
• 5+ years in product development, systems engineering, sustaining engineering, or product lifecycle management within a regulated industry.
• Knowledge of FDA, ISO, IEC, GMP/QSR, and applicable regulatory requirements.

Responsibilities

• Maintain and evolve product designs throughout the lifecycle as Product Design Owner.
• Provide technical assessments, tradeoff analyses, and risk evaluations to support decisions.
• Lead cross-functional technical decision‑making and align engineering, quality, regulatory, manufacturing, service and commercial stakeholders.
• Lead design changes, technical reviews, and risk management per Baxter's Quality Management System.
• Drive resolution of complex product, quality, manufacturing, and field-related issues.
• Ensure compliance with FDA, ISO, IEC, and applicable design control requirements.
• Partner with Quality, Regulatory, Manufacturing, Service, Supply Chain, Marketing, and Program Management to meet objectives.
• Support complaint investigations, supplier corrective actions, product changes, and post-market activities.
• Identify opportunities to improve product performance, reliability, manufacturability, quality, and cost.
• Mentor and guide engineering teams through problem solving and lifecycle management.

Skills

Product Design Owner

Systems engineering

Cross-functional leadership

Regulatory knowledge

Analytical thinking

Communication

Education

Bachelor's degree

Job description

Baxter International Inc. is seeking a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D.

You will provide technical leadership for Baxter's Exam Diagnostics portfolio, serving as the design authority across the product lifecycle and coordinating cross-functional decision-making to ensure quality, compliance, and business continuity. The role requires strong systems thinking and risk-based decision making, with the ability to influence a global organization.