Name: Sengkeo Kou

Current Location: Clermont, FL

Email: ac4ex7@r.postjobfree.com

Phone: 612-***-****

Experienced Mechanical Engineer:

Extensive experience in working with and designing the following items in accordance with ASME Y14.5 standard o Machined, stamped, sheet metal, metal injection molded (MIM), and plastic injection molded products o Fabrication tools, assembly and inspection holding fixtures

Extensive experience in working on the manufacturing floor, solving manufacturing issues, manufacturing process development, process optimization, and process sustainability.

Proficient with 5S Lean and Six Sigma methodologies.

Proficient with Design of Experiment (DOE), Statistical Process Control (SPC), IQ/OQ/PQ, gauge R&R and Pareto analysis, Root Cause Analysis, and Process Failure Modes Effects Analysis (PFMEA).

Proficient with ISO 9001, ISO 13485 and FDA regulations. Technical Skills

SolidWorks, EPDM, PTC Creo, Windchill, Agile, AutoCAD, AutoDesk Inventor, Microsoft Office, Adobe Photoshop, Adobe Illustrator and Adobe InDesign software packages.

Professional Experience

Genicon, Inc. Winter Park, FL Apr 2017 - Nov 2017

Mechanical Design Engineer

Managed several product enhancement, process improvement and process sustainability.

IQ/OQ/PO, Process verification/validation

Improved existing mechanical and electromechanical products utilizing Design for Manufacturability & Assembly (DFM/A) methodology

Designed part, assembly and inspection tools and holding fixtures

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard

Updated and created Manufacturing Procedures

Performed DOE and SPC

Boston Scientific Minnetonka, MN Sep 2016 - Apr 2017 Sr. Research & Development Engineer

Responsible for product design improvements, design control, risk management and release of documents using Agile and Windchill

Responsible for conducting and verification testing

Responsible for performing root cause analysis

Managed CAPAs associated with product packaging and product distribution using Agile and Windchill o Performed Root Cause analysis, Kaizen, Pareto, 5 Why and Is/Is Not analysis

Managed projects associated with adhering to UDI and CE Mark requirements

Managed projects associated with adhering to reusable surgical instrument cleaning/reprocessing and sterilization requirements, ISO 17664

GT Urological LLC Minnetonka, MN Nov 2015 - Aug 2016 Sr. Research and Development/Manufacturing Support Engineer

Supported manufacturing

o Performed Statistical Process Control, Process Capability, Process optimization and process sustainability

Designed machined, stamped, MIM and plastic injection molded parts

Designed and fabricated compression and flexion test fixture, assembly and inspection tools and holding fixtures.

Improved components/products utilizing DFM/A methodology

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, utilizing GD&T practices

Analyzed part designs utilizing FEA tools

Updated and created Manufacturing Procedures

Authored Test Protocols, executed protocols, and authored Test Reports

Performed DOE and SPC

Managed and collaborated manufacturing process and design improvements with suppliers

Performed Quality and supplier audits

Philips Medisize DDC Hudson, MN Mar 2015 - Oct 2015 Manufacturing Engineer

Performed Process Capability analysis

Collaborated a design of two-part epoxy mixing and dispensing machines with a design team. The machines were equipped with pneumatic and electronic control systems, and as well as a vision inspection system

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, utilizing GD&T practices

Performed DOE and SPC

Harland Medical Eden Prairie, MN Nov 2014 - Mar 2015 Sr. Manufacturing Engineer

Performed feasibility and development of hydrophilic coating processes, and process optimization

Designed holding fixtures for Research & Development (R&D) and manufacturing departments

Performed IQ/OQ/PQ, gauge R&R, DOE, SPC and Pareto analysis

Interfaced with R&D, Quality and Sales departments on status of projects and customer requirements Creganna-Tactx Medical Minneapolis, MN Sep 2013 - Nov 2014 Sr. Research & Development Engineer

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, utilizing GD&T practices

Analyzed part designs utilizing FEA tools

Performed Process Capability analysis on the extrusion machines and re-flow ovens

Managed existing and new projects, including the following tasks o Procured raw materials and supplies to fabricate prototypes and test samples o Deigned fabrication tools, assembly and inspection holding fixtures in accordance with ASME Y14.5 standard, utilizing GD&T practices

Responsible for establishing product requirements, concept prototyping, design and development (including verification and validation), risk/failure mode assessment, performance and safety testing

Maintained detailed documentation throughout all phases of research and development

Reviewed/coordinated external vendors to support development activities

Worked closely with manufacturing engineers to improve manufacturing processes, procedure, and cost

Conferred with management and operations to determine project feasibility and customer requirements for new and existing projects

Zyga Technology, Inc. Minneapolis, MN Nov 2012 - May 2013 Sr. Manufacturing Engineer

Performed Process Capability analysis on micro injection molding equipment

Performed process improvement and process sustainability on the assembly of surgical instruments and packaging

Led Manufacturing Engineering program and supported manufacturing in all engineering issues including documentation, continuous improvement, process optimization, component evaluation, Process Validations, performance issues, and engineering change orders

Designed assembly tools, assembly and inspection holding fixtures in accordance with ASME Y14.5 standard, utilizing GD&T practices

Performed IQ/OQ/PQ, gauge R&R, DOE, SPC and Pareto analysis

Performed Quality and Vendor audits

Defined, authored, and released new manufacturing procedures, work instructions, and routers Zyga Technology, Inc. Minneapolis, MN Sep 2008 - Nov 2012 Sr. Mechanical Development Engineer

Responsible for the development and prototyping medical devices from early concepts through clinical studies to commercialization, in accordance with US and international regulations

Designed machined, stamped, plastic injection molded, and plastic over-molded parts

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, utilizing GD&T practices

Analyzed part designs utilizing FEA tools

Designed test and assembly fixtures equipped with heat, pressure and time controllers

Authored Test Protocols, executed protocols, and authored Test Reports

Perform Quality and Vendor audits

Gyrus ACMI Maple Grove, MN Jun 2007 – Sep 2008

Manufacturing Engineering Support / CAD Specialist

Supported various production lines in solving manufacturing processes and quality issues

Assembled mechanical and electromechanical products

Designed new and modified existing machined, stamped, sheet metal, MIM, plastic injection molded and plastic over-molded parts

Designed new and modified existing assembly, inspection tools and holding fixtures and created engineering drawings in accordance with ASME Y14.5 standard

Performed DOE and SPC

Revised existing and designed new thermoformed trays

Responsible for training all engineers on AutoCAD, SolidWorks, and maintaining drafting standards and best practices Micromedics, Inc. Eagan, MN Aug 2005 – May 2007

Manufacturing Continuation Engineer

Supported various production lines in solving manufacturing processes and quality issues, including manufacturing process optimization, process sustainability and scrap reduction

Improved existing components/products utilizing Design for Manufacturability & Assembly (DFM/A) methodology

Designed assembly and inspection tools and holding fixtures

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, and performed FEA

Updated and created Manufacturing Procedures

Performed DOE and SPC

Designed graphics for IFUs, labels, pouches and boxes, and total packaging requirements

Responsible for labeling requirements, documentation to comply with the FDA, ISO and 13485

Responsible for training all engineers on AutoCAD, SolidWorks and PDMWorks Gyrus Medical, Inc. Maple Grove, MN Aug 2004 - Aug 2005 Mechanical Designer

Designed assembly, inspection tools and holding fixtures

Created 3D CAD models, assemblies and engineering drawings in accordance with ASME Y14.5 standard, utilizing GD&T practices

Analyzed part designs utilizing FEA tools

Performed DOE and SPC

Raymedica, Inc. Minneapolis, MN Feb 1997– Jun 2004 Mechanical Designer

Participated in improving existing and designing new spinal implantable devices

Participated in designing prototype and production tools, fixtures, molds and surgical instruments

Created 3D CAD models, assemblies and engineering drawings, and performed FEA on spinal implantable devices and surgical instruments to support Research & Development efforts

Authored and maintained First Article Inspection procedures

Assisted in the preparation of initial product documentation including the DHF, component and assembly drawings, and manufacturing/inspection procedures.

Lake Region Mfg., Inc. Chaska, MN Oct 1995 – Feb 1997 R&D Technician

Provided support to engineering in the development of new products, process development and the design of production tools and fixtures

Participated in developing, optimizing, and enhancing performance assembly operations for new products

Maintained research and development documentation requirements to support regulatory and legal requirements

Trained production personnel during project transfer, R&D to Manufacturing, Phase

Recommended changes to manufacturing processes or fixtures to achieve desired outcome Lake Region Mfg., Inc. Chaska, MN May 1992 – Oct 1995 Senior QA Inspector

Performed First Article Inspections

Performed in-coming, in-process, and final inspections Part Time Employment:

SolidWorks Customized Training, Hennepin Technical College, Jun 15 - 18, 2004

CAD Instructor, Hennepin Technical College, Jan 2003 – May 2017 o Taught PTC ProE (PTC Creo), AutoCAD, AutoDesk Inventor and SolidWorks software packages in Engineering CAD Technology program

Education:

Bachelor of Arts, Concordia College, St. Paul, Minnesota

Associate in Applied Science (A.A.S.), Hennepin Technical College, Eden Prairie, Minnesota o Engineering CAD Technology

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