Continuous Improvement Product Development

CHARLIE EMATA

Cell: 510-***-****

Email: ********@*****.***

CAREER OBJECTIVE

A challenging career in manufacturing, equipment maintenance & R&D management that utilizes my experience and ability to enhance processes & reduce operational cost through waste elimination, continuous improvement and implementation of LEAN manufacturing principles.

SUMMARY OF QUALIFICATIONS

Progressive involvement in various aspects of Operations Administration, Material and Production Management

Broad experience with strategic planning, quality assurance and product development

Extensive practical and hands-on experience with proven capability for situation analysis and development of creative solutions

Proficient in developing effective and enthusiastic teams that achieve manufacturing performance and customer satisfaction through total participation and empowerment of employees.

Knowledgeable in developing and implementing performance metrics, standards, SPC and accountability system

Proficient in developing and implementing standard procedures, waste elimination, process improvement

Knowledge in setting up and manage product development and pilot lines, concept to product, Design Verification & Animal Study product

Thorough understanding of World Class manufacturing concepts, Demand Flow, Lean Manufacturing, Kanban & Safety Standards

EMPLOYMENT HISTORY

Stryker Corporation Fremont, CA

Equipment Manager (Equipment Maintenance) 08/2013 to 04/2022

• Assess asset/equipment requirement for multiple Neurovascular department locations

• Manage equipment upgrades, scheduling equipment PM, troubleshooting & repairs in all lab locations

• Generate plan and labor forecast for equipment installations, qualifications & equipment readiness assessment that include cutting edge equipment such as Climatic Conditioning Oven, Hydrophilic Coater, Laminators, Coil Winders, Hydraulic Shaker, Accelerated Aging Oven, Pull Tester and others

• Manage equipment spare parts inventory and determine usage frequency of spare parts that utilizes Kanban process

• Initiated database to monitor all equipment performance such as downtime/uptime percentage, yield, equipment utilization & troubleshooting & repair time durations

• Enforce safety protocols, 5S & GMP standards

R&D NV Associate Manager (Prototype) 07/2011 to 08/2013

• Plan and coordinate all activities in the development of neurovascular flow diverter coils & stent for both Acute Ischemic Stroke and Hemorrhagic devices

• Manage activities of concept to product for all neurovascular Target coils, Next Gen Intrasaccular Therapy including TDP, PDP & DV builds in a class 100 cleanroom environment

• Coordinate all product knowledge transfer to manufacturing including training, equipment and tooling

• Waste elimination and continuous improvement implementation

• Manage multiple projects such as lab relocation, new lab implementations & implementation of Flowgate and Trevo prototype lines

• Implementation of 5S, Dashboard visual communication tool and database performance tracking Memry Corporation Menlo Park, CA

Manufacturing Manager (Medical Device, Nitinol Wire & Tubing) 12/2007 to 07/2011

• Responsible for all manufacturing operations of stent including laser cutting and electropolishing; nitinol tubing and wire drawing for various medical device applications

• Manage multiple engineering projects related to process improvement, tooling design, capacity optimization and efficiency improvement utilizing LEAN principles

• Improved stent yield from 85% to 98%, First Pass Yield from 86% to 95% through continuous improvement activities using value stream mapping, 5S, process improvement, new tooling and fixture designs through Kaizen events

• Review and approve ECOs, Equipment IQ/OQ, PQ; Monitor various performance metrics and apply PDCA to resolve issues

NDC Corp./Johnson & Johnson Fremont, CA

Senior Manufacturing Supervisor (Medical Device) 08/2002 to 12/2007

• Managed day to day manufacturing activities of implantable stents and Vena Cava filters

• Production processes include Drilling and Deburring of nitinol tubing, Honing, Expansion, AF Tuning, Electropolishing and Sulfamic Etching, Constraint and Dimensional measuring and Visual Inspection

• Plan and allocate resources to assist new product development; Interact with engineers in various projects including validations, IQ/OQs and manufacturing related continuous improvement activities

• Assisted implementation 1-piece flow manufacturing and resulted to 25% yield improvement, 30% improvement of on- time delivery

• Perform manufacturing audit for GMP compliance and adherence to FDA related requirement Keravision, Inc. (Company Closed) Fremont, CA

Manufacturing Manager (Medical Device) 12/1999 to 8/2002

• Developed the organization and made decisions concerning all aspects of manufacturing that pertains to daily operation in the manufacturing of implantable Intacs

(Intrastromal Corneal Ring) for vision correction medical device

• Managed high quality, cost containment, product delivery, in-process inventories, regulatory compliance (FDA), procedure implementation, training of staff and all other aspect of a class 100 cleanroom manufacturing

• Conducted daily operations meeting and developed timetables, utilizing GANTT charts to manage projects, validation protocols and other continuous and process improvement programs

• Set up, implemented and maintained an M/S Access Database System in Manufacturing To track production performance, reject and yield monitoring WESTERN DIGITAL, INC. (Sold to Komag) San Jose, CA Senior Final Test Equipment Maintenance Supervisor 1/1997 to 12/1999

• Supervised a group of Equipment Maintenance Technicians and Calibrators, supporting, maintenance and repair of Final Test Dept. Equipment in manufacturing and testing of disks, equipment include Certifiers and Glide, Robots, Vacuum packaging and other related disk manufacturing machines in a class 10 cleanroom environment

• Generate equipment PM & repair schedule, maintain spare parts inventory and enforce safety policies

• Monitor yield and performance of test equipment to ensure that equipment is production worthy

• Responsible for IQ/OQ/PQ and all related documentation of new equipment prior to release to production EDUCATION AND TRAINING

• APICS LEAN Enterprise

• J & J various management enhancement and Lean manufacturing principles

• Skillpath Project Management Seminar

• Demand Flow College - Demand Flow Technology (Mixed Models)

• National Malcolm Baldrige Award Criteria Training

• ISO 9000 Auditor Certification

• 7 courses of Total Quality Management (TQM)

• AC/DC Analysis, Digital Electronics - Delta College

• BS in Business Administration, Management Major - COC, Philippines COMPUTER SKILLS

Computer literate in all popular office software programs such as:

• Windows 11 (PC & Mac)

• M/S Excel, M/S Word, M/S Access Database, M/S PowerPoint, M/S Project & M/S Visio AWARDS AND ACCOMPLISHMENT

• Awarded ADAC’s first Quality Employee of the Year

• Awarded ADAC’s Power of One Award

• Stryker Corporation NV – 2 Innovation Awards

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