James McGinley, MBA, CMfgE, LSSBB

Transformational Manufacturing Leader | Driving Operational Excellence & Strategic Growth | Expert in Lean & Six Sigma | Proven Track Record in Medical Manufacturing & Engineering

Indianapolis, Indiana, United States

About

Imagine a manufacturing operation where efficiency is not just a goal but a standard. Where every process is optimized, every team member is engaged, and every challenge is met with innovative solutions. This is the environment I create. As a transformational leader with over 20 years of experience in medical manufacturing and engineering, I thrive on driving operational excellence and strategic growth. My journey has been marked by a relentless pursuit of continuous improvement and a passion for leading change. Skills and Expertise: • Strategic Planning & Execution: Proven ability to lead teams through difficult change, such as M&A’s, facility renovations, regulatory audits, new technology implementation and CAPEX projects. • Operational Excellence: Expertise in Lean and Six Sigma methodologies, resulting in an 18% increase in labor efficiency and a 30% reduction in overhead costs within 12 months. • Regulatory Compliance: Deep understanding of Quality Management Systems (ISO 13485) and FDA regulations, ensuring seamless compliance and operational integrity. • Leadership & Team Building: Skilled in building high-performing teams, improving employee morale, and fostering a culture of continuous improvement. At Kimball Electronics, I led the transformation of operations through talent development, performance management, digitalization, and adoption of innovative technologies. The transformation yielded a 6.5% increase in employee satisfaction score and a reduction in reporting time by 99% that established new standards for operational excellence. Additionally, I successfully guided teams through, FDA audits, two M&A’s and strategic CAPEX projects resulting in enhanced process controls, product quality and customer acquisitions. With a passion for Operational Excellence my career is built on a foundation of continuous improvement and a commitment to driving change. Every challenge is an opportunity to innovate and improve. Whether it is transforming a toxic work environment or implementing lean manufacturing practices, I am dedicated to making a positive impact. Ready to take your manufacturing operations to the next level? Let us connect and explore how my expertise can drive your business forward. Reach out to me today!

Experience

  • Associate Director - IDAP Engineering/Vial Packaging at Eli Lilly and Company
    Jan 2025 - Present · 1 yr 6 mos

  • Kimball Electronics (11 yrs 10 mos)
    • Operations Manager
      Jul 2020 - Jan 2025 · 4 yrs 7 mos

      Establish and implement strategies to maximize profitability, customer satisfaction & improve results of operating metrics. Lead manufacturing operations team in the execution of production requirements to meet on time delivery efficiently, under budget while meeting impeccable quality standards.

    • Manager- Injection Molding Engineering
      May 2019 - Jul 2020 · 1 yr 3 mos

      Conceived, developed, and improved world class injection molding manufacturing capabilities, technologies, processes, and efficiencies to perpetually outperform global competition and deliver maximum customer satisfaction and profitability. • Led & drove efforts to combine two distinctly different teams through an M&A resulting in team collaboration and improved business processes • Developed and implemented strategy to recapitalize injection molding operations in excess of $5.0M, resulting in a 62% increase in machine utilization, 53% reduction in direct labor, stricter process controls and factory 4.0 connectivity • Recruited and grew staff by 28% to support business growth • Led and managed team through facility renovations in preparation for medical manufacturing, resulting in a 25% improvement in customer score card rating

    • Manager-Manufacturing Engineering
      Jun 2015 - May 2019 · 4 yrs

      Led a team of engineers, technicians and specialists assigned to provide support for product commercialization & deliverables, transfer of product from design into production, provide ongoing Manufacturing Product Support and continuous improvement of processes. • Recruited & grew staff by 200% to support business growth & new customer acquisition • Led team to resolve open quality issues, reducing open NCR’s by 76% • Led the implementation of automated maintenance KPI tracker, reducing reporting time by 99%

  • Manufacturing Engineering & Facilities Supervisor at Catheter Research, Inc
    Apr 2008 - Apr 2013 · 5 yrs 1 mo

    Led the efforts of planning, organizing, maintaining, commissioning & improving existing manufacturing process and management of facilities. Incorporated new processes and methods, improve existing operations, manage capital purchase and installation of equipment. • Restructured calibration process resulting in a 92% decrease in non-conformities • Redesigned warehouse resulting in a 50% decrease in material handling and incorporated material segregation practice • Planned developed and implemented new extrusion line resulting in a two-year ROI • Incorporated single piece flow to assembly line resulting in 60% more throughput

  • Engineer at International Cryogenics
    May 2004 - Apr 2008 · 4 yrs

    Led engineering efforts in the design of custom cryogenic equipment and ensured customer requirements were met from design phase though manufacturing. Managed and oversaw pricing negotiations, technical customer support and manufacturing improvements. •Implemented the use of 3D CAD modeling software resulting in a 65% increase in efficiency • Implemented machine set-up procedure reducing the set-up time by 25% •Designed and implemented a drilling jig resulting in a 78% increase in throughput and reduction in set-up time

  • CAD/CAM Technician at Herff Jones
    Jul 2000 - May 2004 · 3 yrs 11 mos

    Designed and manufactured injection molds utilized in the lost wax manufacturing process through the operation of multiple three axis vertical CNC machining centers. • Implemented maintenance process reducing downtime by 15% • Implemented tool grinding process reducing downtime by 50% & mold post machining cleaning by 80%