Principal Engineer, OpEx

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

The Principal Engineer, Operational Excellence (OpEx)is responsible for leading continuous improvement initiatives across the organization, focusing on enhancing operational efficiency, product quality, and overall performance. This role requires a strong background in Lean Manufacturing, Six Sigma methodologies, and a deep understanding of mechanical and electrical manufacturing industry.

What You'll Be Doing

Continuous Improvement Leadership

• Lead and drive continuous improvement initiatives across manufacturing and operational processes to enhance efficiency, reduce waste, and improve product quality.
• Develop and implement CI strategies and methodologies, including Lean, Six Sigma, and other best practices, to achieve organizational goals.
• Implement and support Lean Daily Management System processes throughout the organization.

Project Management

• Manage and oversee OpEx projects from inception to completion, ensuring alignment with business objectives and timelines.
• Collaborate with cross-functional teams to identify improvement opportunities, define project scope, and establish measurable goals.

Data Analysis and Reporting

• Analyze operational data and performance metrics to identify trends, root causes of issues, and areas for improvement.
• Prepare and present reports on OpEx initiatives, project outcomes, and performance improvements to senior management and stakeholders.

Training and Development

• Provide training and mentorship to employees on Lean and OpEx methodologies, tools, and techniques to foster a culture of continuous improvement within the organization.
• Lead workshops and Kaizen events to engage teams in problem-solving and process improvement activities.

Collaboration and Communication

• Collaborate with engineering, quality assurance, production, and other departments to ensure that OpEx initiatives are effectively integrated into daily operations.
• Communicate effectively with stakeholders at all levels, providing updates on OpEx projects, challenges, and successes.

Regulatory Compliance

• Ensure that all continuous improvement activities comply with relevant regulatory standards and quality management systems (e.g., FDA, ISO 13485).
• Work closely with regulatory affairs teams to support compliance efforts related to CI initiatives.

Innovation and Best Practices

• Stay up to date with industry trends, emerging technologies, and best practices in continuous improvement and manufacturing processes.
• Identify and implement innovative solutions to enhance operational performance and drive competitive advantage.

Other Responsibilities

• Perform other duties assigned by management to support the overall goals of the continuous improvement team.

Safety and Regulatory Compliance:

• Proactively contributes to zero harm in the workplace for all employees by complying with legal and corporate (EHS) Environmental Health & Safety requirements, safe work practices, and EHS policies and procedures consistently.
• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment.
• Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met.
• Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training.

What You'll Bring

• Bachelor’s degree in engineering, Industrial Engineering, or Manufacturing; a master’s degree is preferred.
• 7+ years of experience in continuous improvement, process engineering, or operations management, preferably in the medical device or healthcare industry.

Preferred Qualifications

• Certification in Lean Six Sigma (Black Belt or Master Black Belt) or equivalent.
• Experience with quality management systems and regulatory requirements in the medical device industry.
• Familiarity with statistical analysis software and tools (e.g., Minitab, JMP).
• Strong expertise in Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
• Excellent analytical and problem-solving skills, with a data-driven approach to decision-making.

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