Digital Manufacturing Director

Medtronic • Juncos, PR

4d

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 Digital Manufacturing Director will lead the transformation of our medical device manufacturing operations into an ISA-95-compliant, Industry 4.0-ready environment. This role combines strategic vision with hands-on technical leadership, ensuring automation, information systems, and data integrity work seamlessly within a regulated environment. The director will also oversee data analytics initiatives across automated and non-automated assets, leveraging predictive analytics and performance insights to drive operational excellence. The ideal candidate brings deep expertise in manufacturing systems (MES, SCADA, ERP), ISA-95 architecture, latency mitigation strategies, and advanced analytics, with the ability to translate digital concepts into validated, compliant solutions that directly support production and patient safety. Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Requirements

• Requires Engineering bachelor’s degree
• Requires minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years relevant experience with 7+ years of managerial experience.

Nice To Haves

• Bachelor’s degree in Engineering, Manufacturing Systems, Computer Science or related technical discipline
• 10+ years of experience in medical device or life sciences manufacturing, with strong exposure to automation and information systems.
• Proven track record leading ISA-95-compliant digital transformation and analytics initiatives in regulated environments.
• Deep knowledge of cGMP, ISO 13485, FDA 21 CFR Part 11, and data integrity principles.
• Expertise in MES, SCADA, PLCs, OPC-UA gateways, historians (OSIsoft PI), and ERP integration.
• Strong understanding of ISA-95 architecture, system validation (CSV), and latency mitigation strategies.
• Experience with data analytics platforms (Power BI, Tableau, or similar), predictive modeling, and machine learning for manufacturing.
• Familiarity with cybersecurity in OT environments, edge/cloud architectures, and IIoT readiness.
• Knowledge of automation systems (robots, vision, feeders) and their role in validated processes.
• Hands-on leader with strong technical intuition and problem-solving skills.
• Strategic thinker able to balance innovation, latency performance, and regulatory rigor.
• Strong communicator who can bridge technical, quality, and business perspectives.
• Collaborative and pragmatic, capable of leading through influence and credibility.

Responsibilities

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Develop and execute the ISA-95-based Digital Manufacturing Roadmap, aligned with corporate manufacturing and quality strategy.
• Define and lead Industry 4.0 initiatives.
• Establish layered architecture for data flow and system interoperability across ERP, MES, SCADA, historians, and automation layers.
• Partner with IT, Quality, and Operations to ensure data integrity, traceability, and system validation (21 CFR Part 11, GxP).
• Drive global governance and standardization of digital manufacturing platforms and analytics frameworks.
• Oversee deployment, integration, and validation of MES, OPC-UA gateways, historians (OSIsoft PI), and analytics platforms.
• Implement ISA-95 layered architecture and best practices: Network segmentation Event-driven communication (push vs. poll) Edge processing near PLCs Enable parametric data capture and SPC evidence through validated historian systems.
• Lead stress testing and performance validation to improve latency
• Develop and manage data analytics programs to: Aggregate data from automated and non-automated assets Apply predictive analytics for equipment performance, quality trends, and process optimization Support OEE dashboards and advanced KPI reporting
• Build and lead a cross-functional Digital Factory team combining automation, data, and IT system engineers.
• Champion digital culture and ISA-95 compliance mindset across manufacturing and quality functions.
• Manage vendor relationships for MES, historians, OPC-UA gateways, and analytics platforms.
• Develop training programs to strengthen digital competencies and data-driven decision-making.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• This position is eligible for an annual long-term incentive plan.

What This Job Offers

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