This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Senior Principal Risk Engineer uses state-of-the-art techniques to inspire success in cross-functional teams working collaboratively 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, executes and functionally directs engineering assignments, which require independent judgment.

Key Responsibilities:

• Engaged and influential member of the team as the systems product engineer of moderate to high complexity devices.
• Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
• Analyzes and approves complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
• Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
• Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
• Anticipates technical challenges and risk scenarios and prepares, manages, and executes mitigation strategies to ensure optimal results.
• Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing) required to deliver products to market.
• Establishes, maintains and actively develops associations with cross functional business partners and/or functional peers across Baxter.
• 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.
• Works with Project Management to create and manage schedules for systems and sub-systems.
• Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.

Qualifications:

• B.S. or M.S in Engineering (Mechanical, Electrical, or Software) with 8+ years engineering experience.
• Preferred: Minimum of 5 years of relevant experience in medical device 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
• Cross-functional 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 and project overviews without assistance.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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