Senior Systems Engineer & Product Design Lead (Healthcare)

Baxter Healthcare; Skaneateles Falls (NY); Vor Ort; USD 112.000 - 154.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental coverage

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid time off

Zusammenfassung

Baxter is seeking a Systems Engineer, Product Design Owner (PDO) in the Front Line Care R&D group in Skaneateles, NY. You will act as the technical and design authority for the Exam Diagnostics portfolio, guiding decisions across engineering, quality, regulatory, manufacturing, and service to ensure compliance, quality, and continuous improvement.

You will drive design changes, risk management, and lifecycle activities, collaborating globally to manage complex product issues and ensure

Qualifikationen

• Bachelor's degree in a relevant technical field.
• 5+ years in product development, systems engineering, sustaining engineering, or product lifecycle management within a regulated industry.
• Demonstrated technical expertise across hardware, software, and integrated systems.
• Strong understanding of Design Controls, Risk Management, Verification & Validation, and Product Lifecycle Management processes.
• Knowledge of FDA, ISO, IEC, GMP/QSR, and applicable regulatory requirements.
• Proven ability to lead through influence and drive cross‑functional decision‑making.
• Strong analytical, problem‑solving, and communication skills.
• Ability to thrive in a global, matrixed organization.

Aufgaben

• Maintain and evolve product designs throughout the lifecycle as Product Design Owner.
• Provide technical assessments, tradeoff analyses, and risk evaluations.
• Lead cross‑functional technical decision‑making and align engineering, quality, regulatory, manufacturing, service, and commercial stakeholders.
• Lead design changes, technical reviews, and risk management activities per Quality Management System.
• Drive resolution of complex product, quality, manufacturing, and field 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.

Kenntnisse

Analytical thinking

Problem solving

Communication skills

Influence across organization

Cross-functional collaboration

Ausbildung

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

Jobbeschreibung

Baxter is seeking a Systems Engineer, Product Design Owner (PDO) in the Front Line Care R&D group in Skaneateles, NY. You will act as the technical and design authority for the Exam Diagnostics portfolio, guiding decisions across engineering, quality, regulatory, manufacturing, and service to ensure compliance, quality, and continuous improvement.

You will drive design changes, risk management, and lifecycle activities, collaborating globally to manage complex product issues and ensure