Sr. Manager, Systems Engineering

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. 

Your Role at Baxter

As Senior Systems Engineering Manager, participate on the technical team in the application of standard system engineering principles, methods, and techniques (Requirements Management, Risk Management, Configuration Management) to resolve difficult problems, from conception to final design.  Plans and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures, and criteria with minimal guidance.

What You'll be doing

Create and drive Systems Engineering vision that aligns with the Medication Delivery, Infusion System and Applications organization's vision and strategic plan. Utilizes solid understanding of engineering theory and best-practice in a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Provides direction to Technical leaders that are accountable for complex designs.  Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.

Specific responsibilities include:  

• Leads Infusion System Platform development and life cycle management activities.
• Drives Connectivity requirements development for electro-mechanical devices and software applications across portfolio of products and ensuring appropriate cyber security risks are mitigated.
• Functional management of Lead System Designers, Product Design Owners, System Engineering staff, System Engineering process, and Systems Engineering work products.
• Ensure compliance to the product development process and Quality System requirements.
• Manage external partnerships, contractors and 3rd party service providers.
• Guide, mentor, and provide direction to System Engineers.
• Collaborate with other system engineering teams within the organization to establish best practices.
• Develop strategic resource plans and budgets for global engineering resources/labs.
• Direct technical leaders on multiple programs who are responsible for the following:  
• Development of Design Requirements and Risk Management strategy.
• Translating user needs into system requirements, leveraging cross functional partners.
• Leading engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
• Defining test strategies to allow the development of systems verification plans using requirement tracing methods.
• Leading risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case.
• Implementing configuration and change management through the complete product life-cycle, including design, development, and sustaining phases.
• Interfacing with Medical Affairs, Regulatory, Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process.

What you'll bring

• BS in relevant engineering disciplines, MS preferred,
• 12 years of experience.
• Must be well versed in areas of System Engineering around complex therapy systems comprising electro-mechanical systems/sub-systems, as well as disposables.
• Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel. 
• Must be able to provide solutions that reflect understanding business objectives and cost implications.  
• Experience with requirements management, design control requirements (CFR 820.30, ISO 13485), and risk management (ISO 14971). 
• Experience in application of DFSS, DMAIC and CMII techniques/principles are plusses. 
• Proven track record of management/leadership effectiveness.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includ