Principal Systems Engineer (Product Design Owner)

Quick Facts

• Role: Systems Engineer, Product Design Owner (PDO)
• Focus: Baxter’s Exam Diagnostics product portfolio across the product lifecycle

Description

Serve as the technical and design authority for assigned products in the Exam Diagnostics portfolio. Maintain and evolve product designs through the product lifecycle by leading cross-functional technical decisions, managing product changes, and ensuring compliance, quality, performance, and business continuity. Provide technical assessments, tradeoff and risk evaluations, and resolve complex product, quality, manufacturing, and field issues.

Responsibilities

• Maintain and evolve product designs throughout the product lifecycle
• Perform technical assessments, tradeoff analyses, and risk evaluations
• Lead cross-functional technical decision-making across engineering, quality, regulatory, manufacturing, service, and commercial stakeholders
• Lead design changes, technical reviews, and risk management in accordance with the 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
• 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 on technical problem solving and lifecycle management

Requirements

• Bachelor’s degree in Systems, Biomedical, Electrical, Mechanical, Computer, Software Engineering, or a related technical field
• 5+ years of experience in product development, systems engineering, sustaining engineering, or product lifecycle management in 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

Benefits

• Medical and dental coverage starting on day one; life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP) and 401(k) Retirement Savings Plan (with options for employee contributions and company matching)
• Flexible Spending Accounts; educational assistance programs
• Time-off: paid holidays; paid time off ranging from 20 to 35 days based on length of service; family and medical leaves of absence; paid parental leave
• Additional benefits: commuting benefits, employee discount program, Employee Assistance Program (EAP), and childcare benefits