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Director Systems Engineering

https://www.baxter.com/ Logo

Baxter

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Location:
United States, Round Lake

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Category:
Research and Development

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Contract Type:
Employment contract

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Salary:

184000.00 - 253000.00 USD / Year
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Job Description:

As the Director Systems Engineering, Infusion Systems, you will lead the development and delivery of Baxter Healthcare's Infusion Systems, championing the voice of the customer and driving innovation, while ensuring safety and efficiency. This position involves managing a global team, creating strategies, ensuring compliance with medical device regulations, and driving innovation in medical fluid management devices.

Job Responsibility:

  • Lead and develop global systems engineering teams based in Round Lake, IL, Bangalore, India, and Medina, NY
  • Create, effectively communicate, and deploy the strategy for the team that aligns with the overall systems organization strategic plan
  • Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms
  • Lead systems design validation across all platforms
  • Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics, and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives
  • Collaborate to ensure alignment and traceability of requirements throughout the product development process
  • Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks
  • Lead resource demand planning, allocation, and actuals
  • Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement
  • Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards
  • Ensure robust verification and validation processes are in place to guarantee product quality and compliance with medical device regulations
  • Maintain effective communication with internal and external stakeholders, including regulatory bodies, to ensure product compliance and market readiness
  • Contribute to innovation by identifying opportunities to improve the infusion system
  • Ensure that new learnings from one platform are considered and applied correctly across the entire infusion system platform
  • Oversee the generation of all systems deliverables, including system requirements, design documents, test plans, and user documentation
  • Advance verification capabilities, lab, and automation, ensuring they meet the defined requirements and are of high quality
  • Provide leadership for resource staffing and project execution for the team with proactive management of technical and project risk to ensure delivery of business commitments
  • Identify and manage product development risks related to system development, regulatory non-compliance, and project delays
  • Represent the systems engineering team in meetings, presentations, and other communications with internal and external stakeholders
  • Foster a collaborative work environment with strong working relationships within and across teams, functions, and with strategic external partners
  • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
  • Make adjustments and assign resources as necessary to ensure the QMS is adequately implemented and monitored
  • Foster a culture of continuous improvement, encourage the adoption of new tools and methodologies, and promote best practices to improve the quality of product and efficiency of development processes

Requirements:

  • Bachelor's or Master’s degree in Systems Engineering, Biomedical Engineering or a related field
  • Minimum of 10 years of experience in systems engineering, with a focus on medical fluid management devices (electromechanical pumps) in the medical device industry
  • Demonstrated experience leading, developing and managing engineering teams in a highly regulated environment
  • Strong technical skills, with a deep understanding of systems engineering principles and practices
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
  • Critical thinker, strong problem-solver, analytical
  • Proactive approach to project management, able to address potential risks and issues before they become critical
  • Organized, able to prioritize tasks effectively
  • Passionate about ensuring the safety and effectiveness of medical devices, and committed to delivering high-quality products that meet user needs
  • Customer focus, with a deep understanding of user needs and preferences, and a commitment to designing and developing products that meet these needs
  • Innovative, able to find opportunities for improvement and drive the development and implementation of new technologies, features, and capabilities
What we offer:
  • Support for parents
  • Continuing education/professional development
  • Employee health & well-being benefits
  • Paid time off
  • 2 days a year to volunteer
  • Medical and dental coverage that starts on day one
  • Basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP) with company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays and parental leave
  • Commuting benefits
  • Employee assistance program (EAP)
  • Childcare benefits

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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