Senior Manager – IT Manufacturing Applications

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $141.8k - $236.4k / year

⏰ Full Time

🟠 Senior

💻 IT Support

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• Lead team of experienced professionals in technical design, development and implementation, and lifecycle support for global manufacturing platforms • Ensure compliance with GMP/GxP, ISO 13485, and FDA 21 CFR Parts 11 and 820 • Drive strategic initiatives including Digital Factory, Reliability-Centered Maintenance, and Manufacturing AI/Analytics • Drive automation with manufacturing business owners throughout the manufacturing process • Support full validation documentation and manage validated systems throughout their lifecycle, including periodic reviews, change control, and re-validation • Participate in testing, release planning, and go-live deployments • Collaborate with operations, quality, and IT teams to ensure seamless integration and process efficiency • Contribute to application roadmaps, portfolio planning, budget submissions, and manufacturing and IT strategic plans • Manage direct reports and support continuous team improvement and development • Manage the responsible area's budget and provide regular forecast updates • Work with Manufacturing leadership to support new product introduction, commercial launch, daily operations, and continuous improvement • Report to the IT Director Manufacturing and Smart Factory

🎯 Requirements

• 10+ years of experience in all aspects of manufacturing systems management, including strategy, development, and support • Experience with Machine Learning, Predictive Maintenance, and AI for Manufacturing • GCP, Agentic AI, Gemini Enterprise / Vertix strongly preferred • Proven track record in system architecture, integration, and lifecycle management within regulated environments • Deep understanding of FDA requirements for validated systems, including GMP/GxP, ISO 13485, FDA 21 CFR Parts 11 and 820, and electronic records/e-signatures compliance • Excellent leadership, communication, and stakeholder management skills • Six Sigma experience / certification strongly preferred • Typically requires a Bachelor’s degree in a technical discipline with 13+ years of industry experience • 5-8 years of previous people management experience • Willingness to travel 15-25%

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Access to career development through in-house learning programs and/or qualified tuition reimbursement • Home office workplace • Flex workplace option may be available for employees within commuting distance of a Dexcom site