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

Creates and drives a systems engineering vision that aligns with the 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:  

• Functional management of System Engineering staff.
• Direct technical leaders on multiple programs who are responsible for the following:  

• Development of a Design Inputs and risk management strategy.
• Translating user needs into system requirements, leveraging cross functional partners.
• Leading engineering resources (Algorithm, Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
• Defining test strategies and development of verification plans and validation plans using requirement tracing methods.
• Leading risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation.
• Leading reliability design and demonstration activities.
• Leading compliance design and certification testing activities.
• Collaborate with medical and clinical teams to aid in the design, and support of clinical studies.
• Analysis of clinical study data to gain insights into medical device design opportunities.
• Implementing configuration and change management through the complete product life-cycle, including design, development, and sustaining phases.
• Interfacing with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process.

• Manage internal as well as contractor and 3rd party service providers.
• Guide, mentor, and provide direction to System Engineers.
• Ensure compliance to the product development process and Quality System requirements.
• Collaborate with other system engineering teams within the organization.

Qualifications 

• BS degree in Engineering or Science field, MS preferred, with approximately 10+ years of practical Electromechanical Medical Device Design experience.
• 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.  
• Prefer deep experience with requirements management tools, design control requirements (CFR 820.30, ISO 13485), and risk management (ISO 14971). 
• Experience in effective application of DFSS, and CMII techniques/principles are plusses. 
• Must have demonstrated effective supervisory and people development skills.

Equal Employment Opportunity

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.
                                                                                                                                                               
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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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.