DANIEL F. HOLTZ
SUMMARY
Manufacturing Engineering Manager / Sr. Industrial Engineer
• Extensive experience employed as a manufacturing engineering
• Certified Six-Sigma black belt
• Knowledge of Lean manufacturing techniques and TQM methodologies
• 14 years in FDA controlled Medical Device and Advanced Wound Care facility
• Lead Value Stream Teams using such tools as Single Piece Flow cells, Visual Shop Floor Management, Process Mapping, and 5S.
• Developed and implemented new products and manufacturing processes
• Process improvements reduced costs and enhanced plant performance.
• Successful in training, coaching and directing technical and production teams
• Unique ability to analyze processes to identify and resolve production problem
• Proven ability to facilitate paradigm shifts and lead change management
• Experience in various industries including medical device, forge, and furniture manufacturing
Core competencies include:
• Project Management • Cost Reductions • New Product Implementations
• Process Validation • Engineering Change Control • Risk Management
• Process Mapping • Self-directed Product Teams • Flow Charting
PROFESSIONAL EXPERIENCE
ALKERMES (Formerly Elan), Gainesville, GA 2012 - Present
Senior Manufacturing Process Engineer
Managed process development of drug manufacturing processes.
• Aided in introduction of Operational Excellence program.
• Completed Set Up reduction project in encapsulation area saving $35,000 annually.
COVIDIEN (Formerly Tyco Health Care), Oriskany Falls, NY 1997 – 2011 Manufacturing Engineering Manager / Senior Industrial / Project Engineer
Managed projects in an FDA-controlled environment for a manufacturer of medical devices such as Naso Gastric vent and feeding tubes, Kiting and guide wires. Spearheaded initiatives with advanced and traditional wound care products such as Hydrophilic foam dressings, Liquid compounding and filling, Q-Tips, and gauze dressings,. Provided new product costing and development of Routers. Directed 6 major projects, two with patents pending. Employed numerous work measurement and time studies to solve production issues. Trained, coached, and developed engineers, technicians, and production workers. Supervised 2 technicians.
• Saved over $1M by identifying and spearheading numerous cost reduction projects
• Reduced costs by 25% by laying out and installing new production lines including RF Welding and estimating additional manpower requirements leading to the introduction of an enhanced product
• Designed Jigs and Fixtures for multiple hand assembly operations including go-nogo gauges to poke-yoke operations as part of a Value Stream team to increase efficiencies and reduce scrap by 50%
• Achieved 100% customer satisfaction responses by collaborating with marketing on numerous product development projects and implementing changes
• Oversaw plant-wide calibration system, performance of calibrations, and scheduling of outside calibration services ensuring regulatory compliance.
• Wrote more than 25 Capital Expenditure Requests (CERs) annually, utilizing software and technical expertise to ensure accuracy.
• Coordinated training with Safety Engineer earning highest OSHA and FDA compliance rates in company.
• Maintained a 5% accuracy rate for cost projections while serving as primary contact for new product development and costing for more than 20 possible products with 6 selected for development.
• Oversaw mold repair / replacement program ensuring high quality of injected molded parts.
DANIEL F. HOLTZ PAGE TWO
• Active team member of Material Review Board / CAPA and Ergonomic Core Team member. Mentored 2 engineers and 1 technician for Green Belt and Lean Manufacturing Certifications
• Supervi...
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