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.
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. 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
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
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. 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).
This position is eligible for an annual long-term incentive plan.
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\name=signon&co\num=30601&co_affid=medtronic)
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com)
It is the policy of Medtronic 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, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") 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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic 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.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic 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, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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