Sr. Principal Systems Engineer,

About the role

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.

Responsibilities

• Lead system-level design and risk management activities in accordance with ISO 14971
• Translate customer, clinical, business, and regulatory needs into clear, verifiable system requirements
• Drive technical strategy, product roadmaps, and design concepts for current and future solutions
• Anticipate technical risks and lead proactive mitigation strategies
• Guide cross-functional teams through complex technical challenges, design decisions, and issue resolution
• Ensure adherence to FDA, ISO, and IEC design control requirements
• Drive lifecycle management excellence across development and post-market phases
• Influence alignment across engineering, quality, regulatory, and business functions
• Serve as a technical expert and mentor, elevating team capability and performance
• Contribute to intellectual property (IP) and support regulatory and audit readiness activities

Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Software, or related field); advanced degree preferred
• 8+ years of engineering experience, preferably in medical devices or regulated industries
• Deep knowledge of: ISO 14971 (Risk Management for Medical Devices), IEC 62304 (Medical Device Software Lifecycle), IEC/TR 80002-1 (Software Risk Management Guidance)
• Proven ability to lead complex, cross-functional programs and make critical technical decisions
• Strong systems thinking with the ability to solve ambiguous, high-impact problems
• Demonstrated influence on technical strategy and product direction
• Broad understanding of clinical, user, and business needs
• Excellent communication skills with ability to tailor messaging to diverse stakeholders
• Strong business acumen and ability to balance technical, financial, and timeline considerations
• Recognized technical expertise and ability to mentor and develop others
• Continuous improvement mindset; challenges the status quo to drive better solutions

Qualifications

• Authorized to work for any employer in the U.S.
• Commitment to continuous learning and professional growth
• Ability to work independently and as part of a team
• Strong problem-solving and decision-making skills
• Effective written and verbal communication skills

Skills

• Technical leadership in medical device development
• System architecture and risk management
• Product strategy and roadmap development
• Complex technical challenge resolution
• Regulatory compliance and documentation
• Lifecyle management and post-market support
• Team mentoring and development
• Intellectual property management

Benefits

At Baxter, we offer a comprehensive benefits package designed to support your well-being. This includes:

• Comprehensive medical and dental coverage starting on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• The Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
• The 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
• Flexible Spending Accounts
• Education assistance programs
• 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
• Childcare benefits

Pay

The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors.

Schedule

Our flexible workplace policy allows for a required minimum number of days a week onsite, but we also offer remote work options. This policy supports our Mission to Save and Sustain Lives.