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Results-driven Senior Leader with over 15 years of experience in healthcare IT, pharmaceuticals, medical devices, and biotech. With a passion for driving innovation, primarily focusing on enhancing patient outcomes and streamlining operations for optimal maximization.Key Expertise𝙎𝙩𝙧𝙖𝙩𝙚𝙜𝙞𝙘 𝙋𝙤𝙧𝙩𝙛𝙤𝙡𝙞𝙤 𝙈𝙖𝙣𝙖𝙜𝙚𝙢𝙚𝙣𝙩: Excels in aligning projects with organizational goals to maximize resource allocation.𝙋𝙧𝙤𝙟𝙚𝙘𝙩 𝙂𝙤𝙫𝙚𝙧𝙣𝙖𝙣𝙘𝙚: Ensures compliance and maintains project integrity throughout the lifecycle.𝘾𝙧𝙤𝙨𝙨-𝙁𝙪𝙣𝙘𝙩𝙞𝙤𝙣𝙖𝙡 𝙇𝙚𝙖𝙙𝙚𝙧𝙨𝙝𝙞𝙥: Foster collaboration among diverse teams drives successful outcomes.Notable AchievementSuccessfully managed complex New Product Development (NPD) programs that generated over $200M in revenue, ensuring projects remain on scope, budget, and schedule.Implemented advanced AI technologies and Agile methodologies, driving innovation across multiple functions on a global scale.With experience at Fortune-Global 𝗙𝗨𝗝𝗜𝗙𝗜𝗟𝗠and Fortune-200 companies such as 𝗠𝗲𝗱𝘁𝗿𝗼𝗻𝗶𝗰, 𝗗𝗮𝗻𝗮𝗵𝗲𝗿, 𝗕𝗮𝘅𝘁𝗲𝗿, and 𝗞𝗶𝗺𝗯𝗲𝗿𝗹𝘆 𝗖𝗹𝗮𝗿𝗸 𝗖𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗶𝗼𝗻, offering a unique perspective that combines deep knowledge in Research & Development (R&D), Project Management Office (PMO), Operations, and Quality Assurance (QA).
Envista Holdings Corporation
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Operations Project Manager And Envista Business System Leader (Opm And Ebsl)Envista Holdings CorporationUnited States -
Graduate EngineerGeorgia Institute Of Technology Jan 2023 - PresentAtlanta, Georgia , Us𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩: Completed 2/3 of the graduate program at Georgia Tech's College of Engineering, maintaining a 4.0 GPA across 6 out of 10 required courses and a practicum. -
R&D Associate Director PmoFujifilm Irvine Scientific Apr 2022 - Nov 2024Santa Ana, Ca, Us𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩: In 2024, implemented AI and Deep Learning technologies for FDA-cleared projects, resulting in $𝟱𝟬𝗠 revenue generation over 5 years after completing three complex New Product Development Projects known as the triple crowns with URL available below.👑👑👑https://www.linkedin.com/posts/james-le_four-years-ago-i-shared-steve-jobs-wisdom-activity-7258189114246639618-Wk1Y?utm_source=share&utm_medium=member_ios👑👑👑 -
R&D Sr. Manager PmoFujifilm Irvine Scientific Jan 2020 - Apr 2022Santa Ana, Ca, Us* Completed a $𝟱𝗠 Innovation & Collaboration Center in Suzhou New District, China and a $𝟮𝗠 R&D Facility expansion within 6 months in Irvine, CA. -
R&D Manager PmoFujifilm Irvine Scientific Apr 2019 - Jan 2020Santa Ana, Ca, UsManaged $𝟯𝟬𝗠 manufacturing expansion in Europe as part of Business Continuity Plan (BCP) & $𝟯𝗠 SAP conversion from Jeeves in ERP for Business Intelligence globally. -
Technical Program Manager - PmoEdwards Lifesciences Apr 2017 - Mar 2019Irvine, Ca, Us𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩: Led Value Analysis Value Engineering (VAVE) projects for $2.2M cost savings.* Led Molex project (Surgical Monitoring Device) for profit maintenance of $𝟯𝟬𝗠 and Maximo project with architect design on SaaS cloud platform & integration of JDE Oracle database including COUPA payment system for real-time transactions of spare parts to reduce costly inventory, unplanned downtime and unplanned over time. -
Quality Assurance ManagerDanaher Corporation Jan 2016 - Apr 2017Washington, District Of Columbia, Us𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩𝙨: Built a scalable QC groups to support 24/7 operations to satisfy On-Time Delivery > 95% without any quality issue. Increased QC productivity through standard work, visual management, and Heijunka graphs for level loading. Manage two operational sites.𝙋𝙤𝙢𝙤𝙣𝙖 - Generated international revenue with this startup site in one quarter through ISO-13485 by implementing QMS with successful BSI audit under MDSAP. For inorganic growth, performed four consolidations after merger and acquisitions into a new site with two buildings > 200,000 ft^2 containing a Distribution Center as part of Supply Chain with imports from Mexico and China.𝙊𝙧𝙖𝙣𝙜𝙚 - Eliminated $𝟲𝟱𝟬𝗞 of unbudgeted expenses from OT and staffing agency incurred in 2016 by December 31, 2018 through optimization of standard work with time studies. -
Operations Manager | Danaher Business System Leader (Dbsl)Danaher Corporation Aug 2014 - Dec 2015Washington, District Of Columbia, UsPROFESSIONAL HIGHLIGHTS𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩𝙨: Identified a successor from Danaher to sustain these metrics prior joining KavoKerr of Danaher since plant's stretch goals had sustainable TAT after Danaher's M&A.* Led Global Inventory Reduction by $𝟰𝗠 through Danaher’s Problem-Solving Process with ABC items.* Increased $𝟭.𝟰𝗠 revenue to exceed Year-Over-Year stretch goal of $𝟲.𝟱𝗠 through customer acquisition for Training & Activation Department using Danaher Problem Solving process. -
Process Improvement Manager (Pharma Bu)Baxter International Inc. Jul 2013 - Aug 2014Deerfield, Illinois, Us𝙆𝙚𝙮 𝘼𝙘𝙝𝙞𝙚𝙫𝙚𝙢𝙚𝙣𝙩𝙨: Won BioScience Operating Awards for PHARMA BU on OTD in 2013 and 2014.* Reduced Cost of Poor Quality by $𝟮𝗠 through DMAIC tools with robust prevention rather than costly correction. -
Opex Senior Principal Engineer 6Σ Black BeltBaxter International Inc. Aug 2012 - Jun 2013Deerfield, Illinois, Us* Conducted Lean Six Sigma training for entire plant as well as New Employee Orientations. Mentored more than 40 Lean & Six Sigma candidates. -
Quality EngineerKimberly-Clark 2012 - 2012Irving, Tx, UsWith initiatives from corporate HQ, traveled weekly to Mexico to improve drug-delivery system for $𝟮.𝟮𝗠 hard saving.
James Le Skills
James Le Education Details
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Georgia Institute Of TechnologyMathematics And Computer Science -
Mit XproFull-Stack Architect -
Mit Sloan School Of ManagementMachine Learning (Ml) -
Mit Sloan School Of ManagementArtificial Intelligence -
Harvard Law SchoolHarvard Negotiation & Mediation Clinical Program -
Cornell UniversityProject Leadership -
University Of RedlandsManagement And Operations -
UclaBiochemistry -
UclaProject Management -
Kaplan UniversitySix Sigma Black Belt -
Georgia Institute Of TechnologyAnalytics For Artificial Intelligence
Frequently Asked Questions about James Le
What company does James Le work for?
James Le works for Envista Holdings Corporation
What is James Le's role at the current company?
James Le's current role is Operations Project Manager and Envista Business System Leader (OPM and EBSL).
What is James Le's email address?
James Le's email address is ja****@****ail.com
What is James Le's direct phone number?
James Le's direct phone number is (310) 780*****
What schools did James Le attend?
James Le attended Georgia Institute Of Technology, Mit Xpro, Mit Sloan School Of Management, Mit Sloan School Of Management, Harvard Law School, Cornell University, University Of Redlands, Ucla, Ucla, Kaplan University, Georgia Institute Of Technology.
What skills is James Le known for?
James Le has skills like Validation, Medical Devices, Fda, Capa, R&d, Manufacturing, Quality System, Lean Manufacturing, Continuous Improvement, Pharmaceutical Industry, Regulatory Affairs, Biotechnology.
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