Director Systems Engineering, Baxter

Baxter

Location:

United States, Round Lake

Category:

Research and Development

Contract Type:

Employment contract

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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Director Systems Engineering