Sr. Principal Systems Engineer
Role details
Job location
Tech stack
Job description
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., * 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
Do you have experience in Quality risk management?, Do you have a Bachelor's degree in engineering?, * 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, 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 & conditions
Pulled from the full job description
- Tuition reimbursement
- Paid parental leave
- Employee stock purchase plan
- Parental leave
- 401(k)
- Health insurance
- Paid time off, This is where new knowledge is discovered. Baxter's Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.
- Support for Parents
- Continuing Education/ Professional Development
- Employee Heath & Well-Being Benefits
- Paid Time Off
- 2 Days a Year to Volunteer
Success Profile
What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we're looking for and see if you're a fit.
- Courage
- Action Oriented
- Collaborates
- Cultivates Innovation
- Manages Ambiguity
- Drives Results, 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