Principal Systems Engineer, Product Design Owner,

Baxter International Inc.; Skaneateles Falls (NY); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health benefits

401(k) plan with company match

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter International Inc. seeks a Systems Engineer, Product Design Owner (PDO) within Front Line Care R&D to provide technical leadership for the Exam Diagnostics portfolio throughout the lifecycle.

The role requires extensive cross-functional influence, risk-based decision making, and adherence to FDA/ISO/IEC/QMS standards, with global collaboration and ongoing design controls oversight.

Qualifications

• 5+ years in product development, systems engineering, sustaining engineering, or PLM within a regulated industry.
• Demonstrated technical expertise across hardware, software, and integrated systems.
• Strong understanding of Design Controls, Risk Management, Verification & Validation, and PLM 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.

Responsibilities

• Serve as Product Design Owner with responsibility for maintaining and evolving product designs.
• Provide technical assessments, tradeoff analyses, and risk evaluations for product and business decisions.
• Lead cross-functional technical decision-making and align engineering, quality, regulatory, manufacturing, service, and commercial stakeholders.
• Lead design changes, technical reviews, and risk management 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.
• Support complaint investigations, CAPAs, product changes, and post-market activities.
• Identify opportunities to improve product performance, reliability, manufacturability, and cost.
• Mentor engineering teams in problem solving and lifecycle management.

Skills

Systems engineering

Product development

Regulated industry

Design Controls

Risk Management

Cross-functional collaboration

Regulatory knowledge

Education

B.S. in Engineering

Tools

Quality Management System

Job description

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

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.

What You'll Be Doing

• 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.

What You'll Bring

• 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.

Preferred Qualifications

• 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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits At Baxter (except For Puerto Rico)

This is where your well‑being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well‑being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short‑term and long‑term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time‑off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.