Senior Systems Engineer, Product Design Owner

Thisiscny; Town of Skaneateles (NY); On-site; USD 112,000 - 154,000; Full time

Job summary

Baxter is seeking a Principal Systems Engineer, Product Design Owner, to provide technical leadership for the Exam Diagnostics portfolio throughout the product lifecycle. You will act as the technical and design authority, guiding cross‑functional teams across engineering, quality, regulatory, and manufacturing to deliver safe, compliant medical devices.

This role emphasizes systems thinking, risk‑based decisions, and influence across a global organization.

Qualifications

• Bachelor's degree in a related technical field.
• 5+ years in product development or systems engineering in a regulated industry.
• Demonstrated technical expertise across hardware, software, and integrated systems.
• Strong knowledge of Design Controls, Risk Management and Verification & Validation.
• Knowledge of FDA, ISO, IEC, GMP/QSR regulatory requirements.
• Proven ability to lead through influence across cross‑functional teams.
• Strong analytical and communication skills.

Responsibilities

• Serve as Product Design Owner with responsibility for maintaining and evolving product designs throughout the product lifecycle.
• Provide technical assessments, tradeoff analyses, and risk evaluations to support product and business decisions.
• Lead cross‑functional technical decision‑making and influence alignment among engineering, quality, regulatory, manufacturing, service, and commercial stakeholders.
• Lead design changes, technical reviews, and risk management activities in accordance with 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 achieve product and business 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 technical problem solving and product lifecycle management.

Skills

Product development

Systems engineering

Regulatory knowledge

Cross-functional leadership

Analytical skills

Communication skills

Global/matrixed org

Education

Bachelor's degree in engineering

Job description

Baxter is seeking a Principal Systems Engineer, Product Design Owner, to provide technical leadership for the Exam Diagnostics portfolio throughout the product lifecycle. You will act as the technical and design authority, guiding cross‑functional teams across engineering, quality, regulatory, and manufacturing to deliver safe, compliant medical devices.

This role emphasizes systems thinking, risk‑based decisions, and influence across a global organization.