Sr. Principal Systems Engineer,

Baxter International Inc.; Milwaukee (WI); Hybrid; USD 128,000 - 176,000; Full time

Benefits offered by this job

Annual incentive bonus

Medical and dental coverage from day 1

401(k) plan with company match

Job summary

Baxter International Inc. is seeking a Sr. Principal Systems Engineer to drive the technical roadmap for medical device product families.

You will lead cross-functional teams across engineering, clinical, and marketing to translate market needs into robust system requirements and architecture. The role emphasizes risk management, design history files, and regulatory compliance, with collaboration across R&D and manufacturing.

Qualifications

• Bachelor’s degree in a technical field and 8+ years of experience in medical devices.
• Knowledge of ISO 14971 and IEC 60601 is preferred.
• Experience applying systems engineering in an Agile SAFe setup.

Responsibilities

• Manage and own the technical roadmap for product families; align with Upstream Marketing.
• Collaborate with Program Management, Marketing, and Customers to translate market needs into requirements.
• Lead design inputs and digital interface requirements development.
• Develop user and clinical workflows to drive requirement analysis.
• Own system architecture and lead multi-disciplinary resources.
• Coordinate and resolve interface issues across engineering, manufacturing, regulatory, and marketing.
• Define test strategies with verification engineers for validation plans.
• Oversee DHF documentation and IEC usability requirements.
• Lead risk management activities per IEC 14971.
• Support CAPA, post-market investigations and cross-functional product support.

Skills

Technical leadership

Systems engineering

Medical device knowledge

Agile SAFe

MATLAB

Azure DevOps

Cross-functional teamwork

Decision making

Education

Bachelor’s Degree in Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area

Tools

Polarion

Trackwise

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

The research we do and the products we develop improve outcomes for patients around the world. As a Sr. Principal Systems Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others!

What You'll Be Doing

• Manage and own the technical roadmap for product families, integrate technical roadmaps with Upstream Marketing product roadmaps
• Work with Program Management, Upstream Marketing and Customers to plan new development, initiate product change activities, understand & translate market needs into technical product requirements & workflows. Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements. Serve as liaison VOC from Marketing to Engineering.
• Work with Engineering Project Management to define and scope projects to achieve program goals. Participate as a member of project teams for the assigned program.
• Lead development of Design Inputs and Digital Interface Requirements.
• Develop User and Clinical Workflows to drive requirement analysis
• Own System Architecture
• Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
• Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market. Lead Decision Making using tools such as Decision Matrices to evaluate trade-offs.
• Resolves interface issues and have the ability to document theory of operations of complex medical product designs.
• Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods.
• Owner of the Design History File (DHF). Responsible for ensuring technical product requirements are clearly & thoroughly documented, and verified & validated. This includes the following:
• Ensures usability requirements are adequately incorporated per IEC 62366.
• Lead technical resource for Risk Management analysis activities per IEC 14971 including capturing hazards, mitigations, and residual risk determination.
• Lead Coordination and review of system and design level requirements to ensure they adequately meet system requirements, market needs, serviceability and manufacturability of the product.
• Member of multi-functional support team; duties as needed include serving as critical issue point-person, lead product support meetings, participate in CAPA activities, asist with complaint & post-market investigations.
• Oversee platform-based product designs that meet needs for multiple portfolios by coordinating shared needs and requirements.

What You'll Bring

• Bachelor’s Degree (Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area)
• 8+ years' of engineering experience on medical devices.
• Knowledge in ISO 14971 Application of Risk Management to Medical Devices
• Knowledge of IEC 60601 Safety Compliance of Medical Devices
• Ability to apply systems engineering principles in Agile SAFe framework by supporting the Product Owner in Epic, Feature and Story development/definition and backlog prioritization
• Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred.
• Strong interpersonal skills with the ability to lead and work collaboratively with others in a team environment
• Able to work in the absence of complete information and make timely decisions performing with great attention to detail
• Excellent verbal and written communication, especially relating to clear, concise, and verifiable requirements.
• Strategic problem solver, organized and able to progress on many different tasks in parallel
• Able to plan, estimate and accurately track deliverables
• Fundamental understanding of Hardware & Software engineering
• Adaptive, open to change and continuously looks for ways to improve and simplify sophisticated work
• Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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. To that end, this position has a salary range of $128,000 to $176,000 and also includes an annual incentive bonus. The above range represents the expected salary range for the position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, business line, and geographic/office location.

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. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter.

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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.