Senior Systems Engineer

Senior Systems Engineer – Baxter International Inc.

Join Baxter’s mission to save and sustain lives by applying state‑of‑the‑art techniques to infusion system device designs. This role drives risk management and regulatory compliance across the product lifecycle.

Senior Risk Engineer uses state‑of‑the‑art techniques to achieve Infusion System device designs that meet customer needs. Guides technical team in resolving difficult problems in a collaborative environment. Applies standard risk management principles, methods, and techniques to ensure products meet medical device design control best practices. Plans, and executes engineering assignments under the guidance of the Product Risk Management Owner.

• Engaged member of the team as a systems risk management engineer of moderate to high complexity devices.
• Coordinates efforts of functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
• Analyzes complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
• Ensures R&D review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional project team to make decisions.
• Understands and contributes to resolution of competing constraints among inter‑related functions (e.g. engineering, manufacturing, regulatory, marketing) required to deliver products to market.
• Utilizes creative thinking and teamwork to resolve conflicts.
• Makes proficient and disciplined critical decisions and systems deliverables (e.g. program milestones, technical design reviews).
• Embraces team and management decisions while also raising issues to appropriate level.
• Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.

• B.S. in Engineering (Biomedical, Mechanical, Electrical, or Software) with 3+ years engineering experience or Masters with 1+ years.
• Minimum of 2 years of relevant experience in a regulated industry.
• Demonstrated knowledge of engineering disciplines and solid knowledge of related disciplines, Systems, Electro/Mechanical, Fluid Mechanics, Materials Science, etc.
• Experience applying ISO 14971 to the design and development of complex, safety critical medical devices.
• Medical Design experience with Infusion Pumps and Syringe Pumps is a plus.
• Team collaboration experience, including technical and non‑technical work.
• Success in delivering results on technical challenges including investigative and problem solving skills.
• Has organized and presented technical overviews without assistance.

Compensation:
The estimated base salary for this position is $88,000 to $121,000 annually. The salary may vary based on location, skills, experience, and other factors. Eligibility for discretionary bonuses is included.

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.

Baxter offers a comprehensive benefits package including medical, dental, life, disability, and retirement plans, as well as paid time off, parental leave, and more. For details, please speak with your recruiter.

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.

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.

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.

Mid‑Senior level

Full‑time

Information Technology

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Hospitals and Health Care