Principal Systems Engineer, Product Design Owner,

Quick Facts

Systems Engineer, Product Design Owner (PDO)

Description

Serve as Product Design Owner with responsibility for maintaining and evolving product designs throughout the product lifecycle for Baxter's Exam Diagnostics product portfolio. Provide technical assessments, tradeoff analyses, and risk evaluations to support product and business decisions, and lead cross-functional technical decision-making across engineering, quality, regulatory, manufacturing, service, and commercial stakeholders. Ensure compliance with FDA, ISO, IEC, and applicable design control requirements while driving resolution of complex product, quality, manufacturing, and field-related issues.

Responsibilities

• Maintain and evolve product designs throughout the product lifecycle as Product Design Owner
• Provide technical assessments, tradeoff analyses, and risk evaluations
• Lead cross-functional technical decision-making and influence alignment
• 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 through technical problem solving and product 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 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

Benefits

• Medical and dental coverage starting on day one
• Basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP) with options for contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence and paid parental leave
• Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits