Medtronic
Digital Manufacturing Director – Medtronic
Medtronic invites applicants for the Digital Manufacturing Director role to lead digital transformation and innovation in medical device manufacturing.
A Day in the Life As a separate entity, Medtronic’s Diabetes business offers an exciting opportunity to drive meaningful innovation and enhance patient care. The Digital Manufacturing Director will transform medical device manufacturing operations into an ISA‑95‑compliant, Industry 4.0‑ready environment, combining strategic vision with hands‑on technical leadership. The director will also oversee data analytics initiatives across automated and non‑automated assets, leveraging predictive analytics and performance insights to drive operational excellence.
Responsibilities
Develop 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.
Qualifications
Engineering bachelor’s degree (minimum).
10+ years of experience in medical device or life sciences manufacturing, with strong exposure to automation and information systems.
7+ years of managerial experience, or advanced degree with 8+ years of experience and 7+ years of managerial experience.
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.
Key Performance Indicators
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.
Physical Job Requirements The above statements describe the general nature and level of work being performed by employees assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP) and for an annual long‑term incentive plan.
About Medtronic Medtronic leads global healthcare technology and boldly address the most challenging health problems. Our mission— to alleviate pain, restore health, and extend life—unites a global team of 95,000‑plus passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
Equal Employment Opportunity Medtronic provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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A Day in the Life As a separate entity, Medtronic’s Diabetes business offers an exciting opportunity to drive meaningful innovation and enhance patient care. The Digital Manufacturing Director will transform medical device manufacturing operations into an ISA‑95‑compliant, Industry 4.0‑ready environment, combining strategic vision with hands‑on technical leadership. The director will also oversee data analytics initiatives across automated and non‑automated assets, leveraging predictive analytics and performance insights to drive operational excellence.
Responsibilities
Develop 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.
Qualifications
Engineering bachelor’s degree (minimum).
10+ years of experience in medical device or life sciences manufacturing, with strong exposure to automation and information systems.
7+ years of managerial experience, or advanced degree with 8+ years of experience and 7+ years of managerial experience.
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.
Key Performance Indicators
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.
Physical Job Requirements The above statements describe the general nature and level of work being performed by employees assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP) and for an annual long‑term incentive plan.
About Medtronic Medtronic leads global healthcare technology and boldly address the most challenging health problems. Our mission— to alleviate pain, restore health, and extend life—unites a global team of 95,000‑plus passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
Equal Employment Opportunity Medtronic provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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