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

Discretionary bonuses

Health benefits starting day one

Job summary

Baxter International Inc. is seeking a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D to provide technical leadership for Baxter's Exam Diagnostics product portfolio throughout the lifecycle.

You will serve as the technical and design authority, leading cross-functional decision-making, and ensuring ongoing compliance, quality, and business continuity in a global organization.

Qualifications

• Bachelor's degree in a technical field and 5+ years in product development or systems engineering within a regulated industry.
• Experience with hardware, software, and integrated systems across product lifecycles.
• Strong knowledge of Design Controls, Risk Management, Verification & Validation, and Product Lifecycle Management.

Responsibilities

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

Skills

Product development

Systems engineering

Regulated industry

Design Controls

Risk management

Cross-functional leadership

Education

Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Computer, Software Engineering, or related

Job description

Baxter International Inc. is seeking a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D to provide technical leadership for Baxter's Exam Diagnostics product portfolio throughout the lifecycle.

You will serve as the technical and design authority, leading cross-functional decision-making, and ensuring ongoing compliance, quality, and business continuity in a global organization.