Principal Systems Engineer, Product Design Owner
About The Position
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter This Is Where Your Work Saves Lives At Baxter, we are deeply connected by our mission. No matter your role, your work makes a positive impact on people around the world. As a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D, you will provide technical leadership for Baxter's Exam Diagnostics product portfolio throughout the product lifecycle. You will serve as the technical and design authority for assigned products, leading cross-functional decision-making, managing product changes, and ensuring ongoing compliance, quality, performance, and business continuity. This role requires strong systems thinking, risk-based decision making, and the ability to influence across a global, cross-functional organization.
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.
Nice To Haves
- Experience serving as a Product Design Owner, Systems Engineer, Lead Systems Designer, Product Architect, or Technical Lead.
- Experience supporting post-market quality investigations, sustaining engineering, or manufacturing changes.
- Experience with connected medical devices, digital health, or software-enabled products.
- Advanced degree or relevant professional certifications preferred.
Responsibilities
- Serve as Product Design Owner with responsibility for maintaining and evolving product designs throughout the product lifecycle.
- Provide technical assessments, tradeoff analyses, and risk evaluations to support product and business decisions.
- Lead cross-functional technical decision-making and influence alignment among engineering, quality, regulatory, manufacturing, service, and commercial stakeholders.
- Lead design changes, technical reviews, and risk management activities in accordance with Baxter's 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 to achieve product and business 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 technical problem solving and product lifecycle management.
Benefits
- medical and dental coverage that start on day one
- insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
- Flexible Spending Accounts
- educational assistance programs
- 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
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Principal
