Black Belt

Medtronic • Juncos, PR

6h

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. The Black Belt will lead continuous improvement projects across manufacturing and automation systems using Lean Six Sigma methodologies and advanced analytics. This role leverages data from machines, MES, SCADA, historians, and non-automated processes to identify opportunities, reduce variability, and optimize performance. The Black Belt will partner with automation, IT, and operations teams to implement solutions that enhance efficiency, compliance, and digital maturity under FDA and ISO frameworks. Responsibilities may include the following and other duties may be assigned. Develops, implements and sustains process improvement initiatives utilizing Six Sigma methodologies. Defines, designs and implements continuous improvement programs to ensure programs are integrated vertically and horizontally across the organization. Defines improvement projects aligned with business strategies. Analyzes improvement programs and potential results. Facilitates and coaches improvement teams. Establishes and maintains performance metrics to measure program success. Installs process excellence supports for program governance, project reviews, communications, training, certifications and rewards. Continues Improvements Leadership Lead Lean Six Sigma projects targeting automation systems, digital manufacturing workflows, and process optimization. Use data analytics from equipment and manufacturing systems to identify root causes, validate improvements, and sustain gains. Drive initiatives to reduce downtime, scrap, and latency across automated lines. Facilitate Kaizen events and workshops focused on automation and digital transformation. Data-Driven Problem Solving Aggregate and analyze data from MES, SCADA, historians (e.g., OSIsoft PI) systems. Apply predictive analytics and SPC to improve equipment reliability and process capability. Develop dashboards and KPIs for OEE, cycle time, and latency performance. Automation & Digital Manufacturing Focus Collaborate with automation engineers to implement ISA-95 best practices, event-driven communication, and edge processing. Support simplification of SCADA/HMI screens and operator workflows. Partner with IT and Quality to ensure compliance with 21 CFR Part 11, ISO 13485, and GAMP 5 during improvement projects. CAPA & NCMR Resolution Lead root cause analysis for CAPAs and NCMRs related to equipment and digital systems. Implement corrective actions and verify effectiveness using statistical tools and process monitoring. Cross-Functional Collaboration Work with Operations, Quality, and Automation teams to align improvement projects with business objectives. Train and mentor Green Belts and team members on Lean Six Sigma tools and data analytics.

Requirements

• Requires bachelor’s degree
• Requires minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
• Lean Six Sigma Black Belt certification required.

Nice To Haves

• Bachelor’s degree in Engineering, Manufacturing Systems or related technical discipline
• 5+ years of experience in manufacturing, automation, or process improvement in a regulated industry.
• Knowledge of automation systems (PLCs, SCADA, robotics), MES, and data historians.
• Proficiency in statistical analysis tools (Minitab, JMP) and data visualization platforms (Power BI, Tableau).
• Experience with predictive analytics, SPC, and OEE improvement.
• Familiarity with industrial communication protocols (OPC-UA, MQTT) and ISA-95 architecture.
• Understanding of regulatory requirements (FDA, ISO 13485, GxP).
• Data-driven problem solver with strong analytical skills.
• Effective communicator and facilitator across technical and business teams.
• Comfortable working in a regulated, audit-ready environment.

Responsibilities

• Develops, implements and sustains process improvement initiatives utilizing Six Sigma methodologies.
• Defines, designs and implements continuous improvement programs to ensure programs are integrated vertically and horizontally across the organization.
• Defines improvement projects aligned with business strategies.
• Analyzes improvement programs and potential results.
• Facilitates and coaches improvement teams.
• Establishes and maintains performance metrics to measure program success.
• Installs process excellence supports for program governance, project reviews, communications, training, certifications and rewards.
• Lead Lean Six Sigma projects targeting automation systems, digital manufacturing workflows, and process optimization.
• Use data analytics from equipment and manufacturing systems to identify root causes, validate improvements, and sustain gains.
• Drive initiatives to reduce downtime, scrap, and latency across automated lines.
• Facilitate Kaizen events and workshops focused on automation and digital transformation.
• Aggregate and analyze data from MES, SCADA, historians (e.g., OSIsoft PI) systems.
• Apply predictive analytics and SPC to improve equipment reliability and process capability.
• Develop dashboards and KPIs for OEE, cycle time, and latency performance.
• Collaborate with automation engineers to implement ISA-95 best practices, event-driven communication, and edge processing.
• Support simplification of SCADA/HMI screens and operator workflows.
• Partner with IT and Quality to ensure compliance with 21 CFR Part 11, ISO 13485, and GAMP 5 during improvement projects.
• Lead root cause analysis for CAPAs and NCMRs related to equipment and digital systems.
• Implement corrective actions and verify effectiveness using statistical tools and process monitoring.
• Work with Operations, Quality, and Automation teams to align improvement projects with business objectives.
• Train and mentor Green Belts and team members on Lean Six Sigma tools and data analytics.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees