Engineer Manufacturing

OBJECTIVES: To obtain a challenging Manufacturing/Process/Quality Engineering position utilizing my experience and education within a dynamic and creative environment.

SUMMARY OF QUALIFICATIONS:

Experienced with FDA, GMP, ISO 9002 & 9001/13485, MRP, KANBAN, JIT, FMEA, PFMEA, IQ, OQ, PQ, Lean MFG, DFM, DFX, Value Stream Mapping (VSM), Kaizen.

Strategy on Lean Manufacturing and Validation Processes for Manufacturing to improve operating efficiency.

Organized, developed, maintained and validated manufacturing processes and drawing review for DFM.

Monitored, maintained productive working relationships with customers and suppliers to ensure successful resolution of problems.

Introduced new products into Manufacturing.

Skills in MS Office, AutoCAD and SolidWorks.

PROFESSIONAL EXPERIENCE:

SINGULEX INC., Alameda, CA (2 yrs and 9 mo) 10/2012 – 6/2015

Medical Devices Manufacturer (Erenna Immunoassay system)

Manufacturing Engineer

Communicated with suppliers to ensure high level of consistency and quality to improve manufacturability of instrument systems

Managed design change, procurement, implementation and qualification of manufacturing and test equipment.

Reviewed and approved Standard Operation Procedures (SOP); changed control for instrument systems to document manufacturing, maintenance, testing and services.

Designed and specified automation equipment used in the development and commercialized of the next generation of instruments.

Performed Optimization, Validation and Verification of the instruments.

Communicated and Interacted with different departments to validate new protocols, and generated SOPs for Optimization and Installation.

Participated with project team leaders involved in the development and commercialized of the next generation of instruments.

Trained internal Support team members and provided technical support for internal and external customers

PLASTIKON INDUSTRIES., Hayward, CA (1 yr and 2 mo) 01/2011 - 3/2012

Plastic Contract Manufacturer

Project/Manufacturing Engineer (NPI Engineer)

Led all activities and readiness for transferring products from pre- production to production stage to meet deadline and target cost.

Managed and scheduled Engineer samples and first article build based on customer requirement.

Developed manufacturing process and work instruction including fixture, work station lay -out using Lean manufacturing method.

Developed, evaluated, validated and maintained Process Flow chart and PFMEA.

Trained production team members (Manager, Supervisors, Leads, and Associates) on new products to insure parts were selected properly and finished goods met customer expectations.

Coordinated and scheduled meetings with Process, Tooling and Quality Engineers to identify and resolve technical and quality issues.

Identified opportunities on new and existing products for process improvement (kaizen).

Feasibility analysis of the different operating costs and other factors with different location

Qualified and logistically evaluate of the location of the suppliers on materials for cost saving

JIMEX CORP., Hayward, CA (6 mo) 06/2010-12/2010

Commercial Refrigerators Manufacturer

Production Manager

Generated production reports, based on sales and forecast.

Reviewed master production schedule and work orders, established priorities for specific custom orders, and revised schedule according to work order specifications, manpower, parts, materials, machines, and equipment.

Collaborated with configuration control and design engineering department regarding product tooling and design to ensure effectual production methods.

BECKMAN COULTER INC, Palo Alto, CA (7 yrs and 2 mo) 05/2001- 07/2008

Medical Devices Manufacturer (centrifugation manufacturing)

Sr. Technical Operations Engineer (Sr. Manufacturing Engineer) 2006 –2008

Provided technical support and leadership to High performance centrifuge product line including fixture design and fabrication, assembly line layout and product flow, methods and process engineering.

Maintained, updated and validated processes and documentation.

Interfaced with Development, Quality, Manufacturing, Purchasing and Suppliers.

Participated in cost reduction teams to identify opportunities for process improvement and cost reduction on new and existing products. Over $50K saved.

Identified and corrected root cause failure using the Corrective Action and Preventative Action process (CAPA).

Managed and executed numerous projects on schedule and within budget.

Technical Operations Engineer (Manufacturing Engineer) 2001 - 2006

Provided technical support and leadership to general purpose centrifuge product line.

Supported New Product Development team that successfullyreleased 3 products to market.

Identified labor and material cost reduction exceeding $40K.

Managed assembly process and identified opportunities for improvement. Provided and documented training as required for process changes.

SPECIALIZED TRAINING:

Effective Communication Skills for Engineering & Management, Silicon Valley Technical Institute, 2009.

Problem Solving Skills for Engineering & Management, Silicon Valley Technical Institute, 2009.

Project Management, Kepner-Tregoe, 2007.

Making Materials Flow, Harris Lean Systems (HLS), 2007.

Value Stream Mapping, Beckman Coulter, 2006.

EDUCATION:

San JoseStateUniversity, San Jose, CA

BS Major: Industrial Technology

Minor: Business Management

References available upon request

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