Larry Ludensky

Work History

Work History

Manager- Hardware Engineering, Producibility and Rapid Prototyping

Beckman Coulter
  • Full responsibility for all New Product Introduction including regulatory requirements and design transfer
  • Managed the transition of new products from development to full production. Accountabilities included full support and coordination of all aspects of New Product Introduction
  • Developed  strategies for the appropriate outsourcing of manufacturing and engineering services
  • Achieved annual savings of $1.9 million by converting batch manufacturing to JIT/Demand Pull
  • Achieved cost savings of $1.5 million by incorporating redesign and process improvements over the product life
  • Managed a team of 20 engineers, designers and technicians for the specifications, design, documentation, testing and validating of various IVD medical instrumentation
  • Researched, developed and implementation Rapid Prototyping, Rapid Tooling, Rapid Manufacturing processes and other Time Compression Technologies for use in the product development process
  • Introduced new products into manufacturing as principal liaison between Product Development, Manufacturing and Supply Chain in a concurrent engineering environment by providing early input and review of designs and acted as the liaison between product development and the supply chain

Senior Director – Operations, Manufacturing and supply chain management

Veracel Scientific, Inc
  • Managed all day-to-day operations for manufacturing, inventory, planning purchasing and supply chain management as well as direct personnel supervision
  • Negotiated and implemented design and build programs with contract manufacturers including responsibility for vendor and contract manufacturing qualification and contract negotiations

Director of Instrument Manufacturing and Supply Chain

Meso Scale Diagnostics
  • Built and directed supply-chain, inventory, planning, purchasing, manufacturing, and facilities which included direct supervision of personnel
  • Built and directed manufacturing and sustaining engineering organizations
  • Responsible of all aspects of new product introduction and day to day operations of a scientific instrumentation start-up company
  • Manage all manufacturing, inventory, planning, purchasing, configuration/document control, supply chain management, and facilities
  • Established a lean manufacturing culture, using six-sigma, 5 S, and other contemporary manufacturing philosophies and techniques to reduce cost, decrease lead times and improve quality
Jul 2007 - Present

Production Manager

Becton Dickinson BioImaging Systems

Production Manager

  • In the process of transforming the manufacturing and operations organizations of a small bioimaging /bioscience (confocal imaging) research division of a large public company from a small research based organization, to a controlled, flexible ISO/CGMP-like operation
  • Achieved favorable manufacturing variances of 18%, $750,000, in the first 3 quarters of my first year
  • Providing the 'voice of manufacturing' input as the Manufacturing Representative on Core Team to the product specifications and product requirements
  • Develop and maintain a production schedule, for the first time in the organization, to support the current sales forecast
  • Developed and implemented processes and programs to integrate the Supply Chain into the design process by training and educating the design community about vendors' process capability so that products can be intelligently "designed for process"
  • Developed and maintained operating and capital expense budgets
Jul 2006 - Jul 2007

Program Analyst (Contractor through Lockheed-Martin)

US Army – Medical Research and Materiel Command (USAMRMC)
  • Consultant to the US Army - Deputy Chief of Staff for Logistics of the US Army Medical Research and Materiel Command (USAMRMC) in managing over $3 Billion of construction, relocation, staff adjustment and transformation activity associated with the Base Realignment and Closure (BRAC) Act of 2005
  • Consultant to the Office of the Facilities Director US Army Medical Research and Material Command in business process re-engineering and transformation
  • Project Manager of design logistics of several aspects of Medical Research facility transitions affected by the BRAC Act of 2005
Apr 2004 - Jun 2006

Immersion Medical, Inc

Director of Manufacturing and Operations
  • Built and directed supply-chain, inventory, planning, purchasing, manufacturing, and facilities which included direct supervision of personnel
  • Built and directed manufacturing and sustaining engineering organizations
  • Responsible of all aspects of new product introduction and day to day operations of a scientific instrumentation start-up company
  • Manage all manufacturing, inventory, planning, purchasing, configuration/document control, supply chain management, and facilities
  • Established a lean manufacturing culture, using six-sigma, 5 S, and other contemporary manufacturing philosophies and techniques to reduce cost, decrease lead times and improve quality
  • Rebuilt the entire operations group which included purchasing, inventory control, product and customer support department, shipping and receiving incorporating lean fundamentals as the basis of operating
  • Managed all contract and internal manufacturing, manufacturing engineering, customer support and service, supply chain management,  inventory, planning, purchasing, configuration/ document control, quality control and facilities
  • Introduced and implemented Lean Manufacturing techniques across all internal organizations and establishing  lean purchasing and lean supply chain processes with vendors

Education

Education

Bachelors of Science

University of Massachusetts

Masters of Science

University of Florida

Summary

Expertise in medical instrumentation and 510K submissions for Class II medical device in FDA, cGMP and ISO 13485 environments. Proven ability to strategically create, initiate, and implement tactical business plans to take organizations to the next level of innovation by utilizing key Lean and 6 Sigma principles of eliminating waste and minimizing variation.  Reputation for solving key problems and being the point of contact for issues. Major accomplishments include:

  • New Product Transfer and Introduction
  • Lean Process Development, Implementation & Execution
  • Cost Savings in manufacturing and its support organizations
  • Building, directing and transforming Organizations
  • Customer Service, New Facility Development, technical support and creating collaborative cultures

Management

  • Ability to quickly extract the crystalline nuggets of information from issues and problems to quickly develop the path forward towards solutions, resolutions and transformations
  • Always the point person
  • Known as the Problem Solver
  • Ability to create order out of chaos
  • Customer Care and product support

Manufacturing Cost Savings

  • · Consistently delivering favorable manufacturing variance. Currently achieving an 18%, $750,000 variance after 3 quarters
  • Achieved annual savings of $1.9 million by converting batch manufacturing to JIT processes using Lean Techniques
  • Achieved cost savings of $1.5 million by incorporating redesign and process improvements over the product life
  • Standard cost reductions of over 60%, improved time-to-market by 15%,

Operations and Engineering

  • New product introduction and transition
  • Quality Systems
  • Manufacturing and Sustaining Engineering
  • Design, Service, Manufacturing and Sustaining engineering management including CAPA administration Document and configuration control including Device Master Records and Design History files
  •  Facilities - design and maintenance
  • Supply Chain

Lean Process Development, Implementation and Execution

  • Using Toyota Production System (TPS) Leading Lean manufacturing and supply chain organizations, 5-S, DMAIC, PDCA, six sigma, JIT and Continuous Process Improvement techniques

New Product Introduction

  • Managed transitions of multiple new products from development to full production including full support and coordination of all aspects of New Product Introduction service and technical support

Objective

Senior-level medical device Operations and Manufacturing Executive, with an engineering background, with over 15 years of experience in New Product Introduction, Lean Process Development, Implementation & Execution, manufacturing, engineering, supply chain, and operations fields.

Expertise in medical instrumentation and 510K submissions for Class II medical device in FDA, cGMP and ISO 13485 environments. Proven ability to strategically create, initiate, and implement tactical business plans to take organizations to the next level of innovation by utilizing key Lean and 6 Sigma principles of eliminating waste and minimizing variation.  Reputation for solving key problems and being the point of contact for issues. Major accomplishments include:

  • New Product Transfer and Introduction
  • Lean Process Development, Implementation & Execution
  • Cost Savings in manufacturing and its support organizations
  • Building, directing and transforming Organizations
  • Customer Service, New Facility Development, technical support and creating collaborative cultures