Principal Systems Engineer, Product Design Owner

Principal Systems Engineer role at Baxter responsible for technical leadership and design ownership of Exam Diagnostics products throughout their lifecycle. The position requires systems engineering expertise in regulated medical device environments, with focus on cross-functional collaboration, compliance management, and product optimization.

Responsibilities

• Serve as Product Design Owner maintaining and evolving product designs throughout lifecycle
• Provide technical assessments, tradeoff analyses, and risk evaluations supporting decisions
• Lead cross-functional technical decision-making with engineering, quality, regulatory, and manufacturing stakeholders
• Drive resolution of complex product, quality, manufacturing, and field-related issues
• Support complaint investigations, supplier corrective actions, and post-market activities

Requirements

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Computer, or Software Engineering
• 5+ years in product development, systems engineering, or lifecycle management in regulated industry
• Technical expertise across hardware, software, and integrated systems
• Strong knowledge of Design Controls, Risk Management, Verification & Validation processes
• Understanding 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

Compensation: $112,000-$154,000 base