John Dinh

***** **** ***** *

Maple Grove, MN ***11

763-***-**** (Cell)

ad10m0@r.postjobfree.com

Summary:

Significant achievement on process and quality projects with Value stream mapping and Lean Six Sigma methodology

Improve MES / PDM projects as well as design and implement existing processes and equipment’s. Well versed in quality Six Sigma DMAIC, Lean manufacturing, Agile, Windchill change management plan & Minitab statistical and software verification and test plan HMI-DOS, process validations IQ, OQ. PQ, TMV and CAPA projects.

Experiences in Solid Works, Process improvement, Protocol builds and testing assembly components. Robotics / Smart Scope -MicroVu programming and Epson robotic, PLC, RF bonding, Braiding, bonding, crimping reflows, laser weld, Co-Extrusion - Injection mold, packaging validation and automation equipment, QFD, DFMEA & PFMEA, CAPA system, SPC and Risk Management control plan.

Experiences with Sheath Delivery Ablation catheter, PTCA&PTA Balloon and Angioplasty catheters, electrophysiology catheterization, braiding and coiling design, Nitinol Stent, chemical etching heat treat and electropolishing and quality control processes. Development projects utilizing value stream mapping-using DMAIC -Process capability Minitab Gage R&R & DOE methodology and tooling development.

Achievements

USA PATENT 6,042,578 Catheters Reinforcing Braid (Boston Scientific, 2001).

EUROPEAN Patent, EP 0807444 Catheter Reinforcing Braid (Pfizer, 1999).

EUROPEAN Patent application, WO2006/122073 Insulative Film Capacitor (Guidant, 2011).

USA PATENT 7,699,889 Method of Insulating Film Capacitors (Boston Scientific, 2010)

USA PATENT 7,426,104 B2 Insulating Film for Capacitor Components (Boston Scientific, 2008)

Education

Black Belt Lean Six Sigma certificate# 687**********, Villanova University (2012)

Green Belt Lean Six Sigma certificate #983**********, Aveta Business Solution (2009)

University of Wyoming, WNU (2008) Mechanical Engineering Degree (BS)

Normandale College (1985-1988) Mechanical Engineering Design (AAS)

Professional Experiences:

Abbott Labs

Mindlance – Haya Rayyan 201-***-****

R&D Engineer 02- 2022/ Present

Support Angioplasty Products and Quality Remediation projects, review and upgrade test lab equipment, DFMEA, DHF, PDM. Process validation IQ, OQ, PQ and PPQ and TMV Test Method developments. Product validation using Minitab statistical software and Windchill CPM. Process improvement projects and design verification and validation.

Philips CO

Insight Global -Kris Spindler 303-***-****

Sr. Process Engineer 12- 2020 / 12-2021

Support PTCA.PTA Balloon products and Quality Remediation projects, review and upgrade test lab equipment, DFMEA, DHF, PDM. Process validation IQ,OQ, PQ and TMV qualifications. Product validation protocols using Minitab statistical software and Windchill, Agile PDM. process improvement CAPA projects for Product Design Verification and validation.

Medtronic (Contract)

Recruiter Integrated Resource - Savi 732-***-**** 09- 2019 / 04-2020

Sr R&D Engineer

Support Perfusion R&D EU MDR Remediation projects, Review and upgrade test lab equipment, PFMEA, DHF, PDM and change management plan, process validation and TMV testing qualification. Test product protocols using Minitab statistical software. Process improvement and CAD design documentation for Product Design Verification.

Medtronic (Contract)

Artech Information- Sameer Tiwari 973-***-**** 02-2016 / 04- 2019

Triple Crown LLC – 512-***-****

Sr Manufacturing Engineer

Support CVG Manufacturing operation projects and Stent operations, equipment and processes validation IQ, OQ and PQ and SV qualification.

Test product protocols using Minitab statistical software. Design fixture with Pro E /Solid Works and process improvement with DMAIC Projects.

CAPA, DFMEA and PFMEA, DOE, TMV, MVP assessment, and PDM validation plan.

Process improvement and CAD spec design documentation for product transfer.

Vention Medical 763-***-**** 12- 2014 / 11-2015

Process Engineering

Implement of projects development build and validation. Work on SOP - MVP matrix, pFMEA, Braiding and coiling processes, Solid Works CAD design and documentation. Minitab statistical ANOVAs and Gage &R.

Build customer electrophysiology protocols and implement processes/ inspections RF tipping, reflow, braiding, tip molding, extrusion and injection molding, leak test and packaging validation process qualification.

Smith’s Medical- (Contract)

Adecco - Bliss Bridgewater 248-***-**** 04- 2014/10 -2014

Sr Manufacturing Engineer

Establish process procedure and testing devices, validation protocols and tooling projects. Work with SOP - MVP matrix, CAPA and DHF, PDM documentation system, Solid-Works CAD documentation, 3D printing, and Electro-Mechanical equipment build with tool assembly, mistake proofing and Lean manufacturing.

Saint Jude Medical, Minnetonka,

Medical Engineering consultant David 754-***-**** 01- 2013/01-2014

Process /Validation Engineer

R&D Engineering support operations, equipment and processes validation IQ, OQ, PQ.

Establish control plan, PFMEA & capability analysis, GD&T, MSA-Gage R&R and DOE by Minitab, Windchill and Solid Works user.

Implement process remediation projects for Lead Delivery system and apply Six Sigma DMAIC to improve process capability/quality related to extrusion and braiding.

Implement DOE’s, MSA, SPC and GD&T, process capability, FMEA’s, and Lean manufacturing projects with Minitab, Solid-Works, Design and MVP plan.

MP&E, Eden Prairie, MN 952-***-**** 02- 2008 /12-2012

Manufacturing Engineering

Technical support of manufacturing operations, equipment and processes validation (IQ, OQ, PQ) and comply with ISO 9001 and 13485 standards.

Test / build Prototype and develop Catheter processes: RF tipping, reflow, braiding, coiling, extrusion, tip molding, injection molding and leak test. Processes improvement yield and cost saving.

Performed DOE’s, Gage R&R, process capability, documentation control plan, DFMEA’s and PFMEA’s, and Lean manufacturing projects with Minitab Statistical analysis and Solid-Works & AutoCAD.

Project assignments: Injection molding projects: Hub molding improvement-DOE and Gage R& achieved high yield & throughput.

RF tip and hole punch for electrophysiology mapping catheter projects: Performed DOE and Gage R&R to minimize scrap yield and update RF parameters.

Quality assurance and implementation of packaging and injection mold quality projects, control plan, PFMEA and statistical process capability...

Revise Manufacturing processes and process flow with Six Sigma projects: 5S, Kaizen, cycle time and waste reduction (60 %) to achieve goal of sale (25M) and Best Small Company profit in 2010.

Guidant-CRM, Saint Paul, MN 2-2002/12-2007

Acquisition of Boston Scientific Corps (2007)

Sr Engineering Technician

Process Excellence –Six-Sigma training courses, Lean manufacturing implementation. Experience with Insight Vision camera, Adept robotic equipment, protocol testing, GMP’s and process validation. Achieved cost saving and processes improvement. Microsoft office, Windchill validation and MP2 documentation, Minitab statistical analysis and Lean Six Sigma participation

Achievement: Insulative Film Capacitor Design Patent award (Process Excellence projects and Lean Six Sigma 2005).

Technical support of manufacturing operations, equipment and processes validation (IQ, OQ and PQ)

Attention to details and adhering to FDA standards and quality initiatives.

Tested protocols using Minitab - SPC statistical analysis software

Troubleshoot and repair Adept Pick & Place, PLC, Insight vision camera, Pick & Place robotic, RF resistance welding, die stamping and Laser weld YAG equipment.

Performed DOE’s, Process Capability, and Lean manufacturing projects

Participated in MRB process, Lean layout, 5 S’s, equipment PM and MPII parts inventory

Tooling & fixtures design modification / upgrade, calibration and repair.

Project assignments: Capacitor insulation problem solving> DMAIC projects: Designed and upgrade insulation process-Achieved 90% in capacitance insulator vs. existing material and yield improvement per DOE and process capability method.

Pfizer Schneider USA, Technology Center; Plymouth, MN 02-1989/08-2001

Acquisition of BSC, USA (1998)

Sr. Engineering Technician

Braider’s equipment modification and upgrade. Lab View integration, setup and, PM repair

Supported manufacturing floor and braiding /extrusion department

Processes and equipment validation upgraded (IQ, OQ, and PQ).

Assisted R&D in product development and tested protocols.

Developed and implemented improvement to manufacturing processes.

Machine and fixture design using AutoCAD and ECO documentation.

Shop floor interaction, preventative maintenance and parts inventory

Develop design concepts, patent submissions and Reversed Engineering.

Project assignments: Product development> DMAIC projects: Designed and upgrade braiding process and packaging process validation.

Achievement: Braid Design Patent (1999) for Guider and Stent Delivery System Catheters Award. Implement the goal of Best Design for manufacturing capability and functional characteristics

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