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?"
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.
Key Responsibilities
Strategic Leadership
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.
Operational & Hands-On Execution
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
Leadership & Change Management
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.
Must Have: Minimum 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 Have:
Education & Experience
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.
Technical Skills
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.
Leadership Attributes
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 (KPIs)
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 are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
MiniMed offers a competitive salary and flexible benefits package
At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. 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.
MiniMed Benefits (http://myminimedbenefits.com) Overview
About MiniMed
MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we've been committed to redefining what's possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it's needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.
Learn more about our business, and our mission here (https://www.minimed.com/en-us/about-us/) .
It is the policy of MiniMed to provide 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (http://www.minimed.com/en-us/la-county-legal-notice) a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
