Digital Manufacturing Director

MiniMed • Juncos, PR

1d

About The Position

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role At MiniMed, we're not just making medical devices — we're revolutionizing how they're made. We are looking for a Digital Manufacturing Director who is ready to lead this transformation. You will be the driving force behind transforming our manufacturing operations. You will combine strategic vision with hands-on technical leadership, ensuring that automation, information systems, and data integrity work seamlessly within a highly regulated environment. From overseeing data analytics initiatives across automated and non-automated assets to leveraging predictive analytics and performance insights, you will drive operational excellence at every level. This is your chance to lead at the intersection of technology, manufacturing, and healthcare. Ready to build what's next?"

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.
• Execution of ISA-95 Digital Factory Roadmap and adoption of global digital standards.
• Reduction in communication faults and latency issues across MES and PLC layers.
• Compliance and audit readiness of digital systems (validated states maintained).
• Integration maturity and uptime of digital systems and automation infrastructure.
• Predictive analytics adoption and measurable improvements in OEE, quality, and downtime reduction.

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 pull) and Edge processing near PLC's
• 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 and 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

• MiniMed 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 stage of your career and life.
• This position is eligible for a short-term incentive called the Short Term Incentive (STI).This position is eligible for an annual long-term incentive plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Director