Sr. Principal Systems Engineer
Baxter International Inc.•Skaneateles, NY
•$128,000 - $176,000•Hybrid
About The Position
As a Sr. Principal Systems Engineer at Baxter, you will serve as a technical leader driving both sustainment and New Product Development (NPD) within the Front Line Care Exam Diagnostics portfolio. You will lead system architecture, risk management, and lifecycle execution across complex, multi-disciplinary programs while influencing product strategy and ensuring alignment with customer, business, and regulatory requirements.
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
- 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.
Nice To Haves
- Advanced degree preferred
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
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
- 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
- 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
