Director of Operational Excellence

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Director of Operational Excellence to join our team in Costa Rica.

The Director of Operational Excellence provides strategic leadership for the organization's Operational Excellence function, driving enterprise-wide performance through the implementation of Lean Manufacturing, Six Sigma, Shingo Principles, and continuous improvement methodologies across Manufacturing, Engineering, Quality, Supply Chain, and other support functions.

This role is responsible for developing and sustaining a culture of Operational Excellence by aligning people, processes, and systems with the organization's strategic objectives. The Director leads transformational initiatives that enhance safety, quality, delivery, productivity, customer satisfaction, employee engagement, and financial performance while championing the Shingo Model and fostering a culture of continuous improvement.

Partnering closely with site and functional leaders, the Director establishes Operational Excellence systems, drives organizational capability, and leads cross-functional teams to deliver sustainable business results and long-term operational success.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Develop and execute the organization's Operational Excellence strategy aligned with business objectives and customer requirements.
• Lead enterprise-wide Lean, Six Sigma, Kaizen, Shingo, and continuous improvement initiatives to improve safety, quality, delivery, cost, productivity, and customer satisfaction.
• Build and sustain an Operational Excellence Management System, including performance management, daily management, problem-solving, visual management, and accountability processes.
• Champion the Shingo Model and foster a culture of continuous improvement, operational discipline, respect, and organizational learning.
• Identify, prioritize, and lead strategic transformation initiatives, digital transformation, and automation projects across the organization.
• Partner with Operations, Engineering, Quality, Supply Chain, HR, and other functions to drive cross-functional alignment and execution of improvement initiatives.
• Analyze operational and business performance data, establish KPIs, and measure the impact and sustainability of Operational Excellence programs.
• Coach, mentor, and develop leaders and teams on Lean, Shingo principles, change management, and continuous improvement methodologies.
• Lead organizational change management efforts to ensure successful adoption and long-term sustainability of improvement initiatives.
• Ensure compliance with Quality Management Systems, ISO, FDA, QSR, and all applicable regulatory, health, safety, and environmental requirements.
• Lead, develop, and manage the Operational Excellence team, including hiring, coaching, performance management, and employee development.

SUPERVISORY RESPONSIBILITIES

Supervises:

• Operational Excellence Manager(s)
• Continuous Improvement Manager(s)
• Operational Excellence Engineer(s)
• Lean Six Sigma Black Belt(s)
• Continuous Improvement Specialist(s)
• Business Excellence Program Leader(s)
• Project Manager(s), Operational Excellence (as assigned)

SUPERVISION

General Direction:

Receives broad strategic direction regarding organizational objectives and business priorities. Exercises considerable independent judgment in determining methods, systems, strategies, and resources required to achieve organizational goals. Influences business decisions across multiple functional areas and leads enterprise initiatives with significant organizational impact.

EDUCATION and/or EXPERIENCE

• Bachelor's degree in engineering, Operations Management, Industrial Engineering, Business Administration, Organizational Leadership, or related field required. Master's Degree preferred.
• Minimum 8-10 years of progressively responsible experience in Operational Excellence, Continuous Improvement, Manufacturing Operations, Industrial Engineering, Business Transformation, or related disciplines, including 3-5 years of leadership experience managing teams, strategic initiatives, or organizational transformation efforts.
• Lean Six Sigma Black Belt certification strongly preferred.
• Training or certification in the Shingo Model, Shingo Principles, Operational Excellence Systems, or related business excellence frameworks is highly preferred.
• Experience within a regulated manufacturing environment, preferably medical device or life sciences, is strongly preferred.

OTHER SKILLS and ABILITIES

• Strong expertise in Lean Manufacturing, Six Sigma, Kaizen, Shingo Principles, Value Stream Management, and change management.
• Proven ability to lead enterprise-wide Operational Excellence and culture transformation initiatives.
• Strong leadership, coaching, and influencing skills with the ability to engage stakeholders at all organizational levels, including executive leadership.
• Excellent analytical and strategic thinking skills with the ability to translate data into sustainable business improvements.
• Demonstrated project and program management experience leading complex, cross-functional initiatives.
• Strong business acumen with the ability to align Operational Excellence initiatives to operational and financial objectives.
• Excellent verbal and written communication, presentation, and facilitation skills.
• Working knowledge of FDA, ISO 13485, QSR, and other applicable regulatory requirements.
• Proficiency with Microsoft Office, project management, business intelligence, and data analytics tools.