Director, Operational Excellence

KEY RESPONSIBILITIES  

Strategic Leadership & Governance 

• Define, deploy, and sustain Integra’s Lean Six Sigma–based Operational Excellence strategy across Supply Chain, Manufacturing, and supporting functions. 

• Establish enterprise CI governance including project selection criteria, prioritization processes, tollgate standards, and KPI dashboards aligned with operational and financial objectives. 

• Develop standardized methodologies, templates, and best practices for Lean, Six Sigma, Kaizen, and advanced problem‑solving. 

Program Deployment & Project Leadership 

• Lead the portfolio of Black Belt and Green Belt initiatives globally, ensuring project rigor, execution  

• Lead a global portfolio of high‑impact Lean Six Sigma projects, ensuring execution discipline, validated results, and sustainability. 

• Partner with Site Directors, Supply Chain, Quality, R&D, and Regulatory Affairs to identify and deliver enterprise‑level improvement opportunities. 

• Apply advanced analytical and statistical tools (DOE, SPC, regression, capability analysis) to solve complex operational, quality, and supply chain challenges. 

Coaching, Training, & Capability Building 

• Mentor and develop CI practitioners, ensuring a robust and sustainable Lean Six Sigma pipeline across all regions. 

• Facilitate leadership workshops, value stream mapping sessions, Kaizen events, and problem‑solving activities. 

• Maintain and enhance CI training curricula suited to life sciences regulatory and operational requirements. 

Cultural Transformation & Daily Management 

• Embed Lean behaviors, standard work, visual management, and data‑driven decision‑making into the Global Operations Daily Management System. 

• Influence leaders at all levels to adopt continuous improvement behaviors and accountability. 

• Lead enterprise rapid improvement events and cross‑functional transformation initiatives that elevate operational maturity and engagement. 

Regulatory, Quality, & Compliance Integration 

• Ensure CI methodologies and improvement activities comply with FDA, ISO 13485, MDR, QSR, GxP, and other applicable regulatory requirements. 

• Partner with Quality and Regulatory to strengthen QMS processes, risk management (FMEA, control plans), process validation, and CAPA effectiveness. 

• Apply statistical and structured problem‑solving approaches to improve product quality, reliability, and patient safety. 

Financial Impact & Executive Reporting 

• Establish standards for financial validation of cost savings, productivity gains, cost avoidance, and service improvements. 

• Deliver executive‑level reporting, dashboards, maturity assessments, and annual CI summaries to the VP of Global Operations Excellence & Strategy. 

• Support capital investment decisions through process capability assessments and operational readiness evaluations. 

REQUIRED SKILLS & MINIMUM QUALIFICATIONS 

Education 

• Bachelor’s degree in Engineering or related field required. 

• Advanced degree (MBA, MS/PhD in Engineering, Operations, or related discipline) preferred. 

• Certified Lean Six Sigma Black Belt required; Master Black Belt certification preferred. 

Experience 

• 10–15 years of progressive experience in continuous improvement within manufacturing, supply chain, or operations. 

• Proven success leading large‑scale transformation programs in regulated environments (medical device, pharmaceutical, biotech). 

• Demonstrated ability to validate operational and financial results with strong analytical and financial acumen. 

• Experience with CI program development, training delivery, daily management systems, and tiered accountability deployment. 

• Experience with process validation, risk management (FMEA), CAPA, QMS systems, and reliability improvement. 

Skills & Competencies 

• Strong organizational, analytical, and statistical skills, with proficiency in tools such as Minitab, JMP, or equivalents. 

• Ability to lead and influence without direct authority across a global matrixed organization. 

• Exceptional executive communication and facilitation skills. 

• Strong project management and change leadership capabilities. 

• Highly self‑motivated team player able to work independently and collaboratively. 

Tools And Equipment Used 

• Standard office equipment (computers, printers, copiers, communication systems). 

• Additional tools may depend on manufacturing, field service, or lab environments, defined in role‑specific documentation. 

PHYSICAL REQUIREMENTS 

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. 

While performing the responsibilities of this role, the employee is expected to: 

• Sit, listen, speak, and move throughout various areas of the building. 

• Travel across all company locations as needed. 

• Periodically lift and/or move items up to twenty-five pounds. 

• Travel domestically and internationally via car, train, or airplane, as required by the role.