Engineer in Quality, validation and lean manufacturing

James Hung

**** ********* *****, ******, ** *****

E-Mail: **********@*****.***

Mobile: 215-***-****

SUMMARY

I am a Senior Validation Quality Engineer with over 15 years of experience in biotech and medical devices industries, specializing in lean manufacturing, process validation, and quality engineering and supplier audit. I collaborated with cross-functional team to perform new product design control, design review, risk management (ISO 14971) and implement new manufacturing process and computer software validation, existing process sustaining, optimization, improve efficiencies and reduce costs. I am certified as a: Six Sigma Black and Green Belts in Lean Manufacturing, Process Validation Quality Engineer (AAMI), and Quality Engineer (ASQ).

Technical Expertise: Product development, design transfer to suppliers (internal & external), commissioning/quality system improvement, work instruction, and process validation of orthopedic implants, biologics products, and surgical instruments. Prepared Master Validation Plans; performed NCR & CAPA, GR&R, Statistical Analysis, and Risk Management FMEA. Extensive experience in ISO 7 & 8 Clean Room, Facility Validation, Process Water System, Autoclave and Sterile Packaging.

Program Management: Served as the Quality and Validation lead on cross-functional teams to develop sound manufacturing

processes and to perform production optimization, utilizing Lean Manufacturing methods. Project management experiences in cost realignment, technology transfer, and scale-up functions in biomedical aseptic GMP environments.

EXPERIENCE

Edwards Life Sciences Irvine, California

Sr. Quality Validation Engineer (Contractor) July 2017- Present

Joined the Heart Valve Technology teams to develop new Resilia Aortic Valve Conduit manufacturing process and performed validation of Epilog Laser Cutter, Stabilizer Chamber, Pouch Sealer, Biosafety Laminar Flow Hood, Isolator (IQ & OQ) in Kettering ISO Class 6 Clean Room.

Performed Deionizer and Desiccator feasibility test and TMV validation.

Write SOP for Resilia Aortic Valved Conduit product assembly process and work instruction. For new product design control process with design transfer verification & validation. And complete design transfer to manufacturing.

SeaSpine Orthopedics Corp. Carlsbad, California

Sr. Quality Validation Engineer- Quality Engineering April 2016–July 2017

Create and maintain Master Validation Plans of SeaSpine Orthopedics. Collaborated with cross functional team to develop new product process start from design review, design verification and validation and design transfer to suppliers activities.

Validated new PEEK Ti-Coating and sterile packaging process; implemented design transfer to production (e.g., machining, passivation, laser marking, sterile packaging in ISO class 7& 8 clean rooms and Trend software validation) at supplier sites. Conduct process statistical analyses (Cp, Cpk) using Minitab.

Develop and validate CNC machines, Incubator and Autoclave equipment IQ/OQ/PQ. Review Supplier Mfg. Deviation Reports and worked on Quality CAPA to conduct nonconforming product root cause analysis and to implement corrective actions and improve supplier manufacturing processes.

Write and approve internal & external supplier special process validation protocols and completion reports for Laser Welding, Anodize, Titanium and HA coating manufacturing processes.

DePuy Synthes, a Johnson & Johnson Company West Chester, Pennsylvania

Sr. Validation Quality Engineer Quality Assurance April 2012 – March 2016

Created Master Validation Plans of DePuySynthes Cervical and Lumbar Spine product lines. Validated cleanroom sterile packaging processes and chemical finishing.

Completed qualification of SyntheCel Dura Repair biological purification process. Developed and equipment validation.

Conducted training in Quality System and Validation Procedure. Managed Quality CAPA work stream to conduct non -conformity investigation, root cause analysis, and implement a corrective actions plan to improve manufacturing processes.

Participated internal & external audit.

Supported computerized system validation includes Clean Room Trend Monitoring system, Process water, and Allen Bradley PLC chemical finishing system ( Electro Polishing, Anodization, Passivation)

Key contributor on Quality MRB and CAPA team that conducted root cause analysis of product failure, disposition and implemented corrective actions to improve manufacturing processes.

Medtronic Spinal & Biologics Memphis, Tennessee

Sr. Concurrent Engineer March 2007 – April 2012

Collaborated with functional team and Suppliers to develop the process and validation of Cervical Plate System and Pyramid Lumbar Plate Systems, resulting in successful market launch of both products.

Worked with cross functional team to develop new TSRH 3Dx Spinal OsteoGrip Screws HA coating process, performed process validation and design transfer. Led team to successfully complete the project 3 months (25%) ahead of schedule.

Led an Oral and Maxillofacial cross-functional team and vendors to develop new reconstruction products, including bone screws, TiMesh sheets and related surgical instruments kits

Process development and design transfer for Focus Minimally Invasive Spine Surgical (MIS) instruments used in Spinal PLIF and DLIF surgery.

BioHorizons Implant System Hoover, Alabama

Principal Engineer March 2004 – March 2007

Lead 2 manufacturing engineers to develop manufacturing and cleaning processes for dental implants. Performed design transfer HA coating process to external supplier. Responsible for training and developing project goals and tracking progress of team.

Managed Dental Lab. and operate 3-D Scanner, CAD/CAM equipment and 5-axis CNC Mill to fabricate dental abutments, porcelain crown and bridges for customers.

Lead team to perform Equipment Validation and Process Validation, IQ/OQ/PQ of dental bone screw machining process and HA coating process from supplier.

Validated modular ISO Class 7 Clean Room and Heat Sealer for assembly and packaging.

Con/Med, Linvatec Inc. Tampa, Florida

Senior Manufacturing Engineer with Six Sigma Black Belt August 2000 – March 2004

Led Kaizen team to perform continuous process improvement. Utilized six sigma and lean manufacturing methodologies to analyze and streamline shoulder tissue anchor driver manufacturing process. Achieved cost savings of $200,000 annually.

Led engineering team to troubleshoot tray and pouch packaging failure and re-engineered packaging procedures for validation and to meet FDA standards.

Developed machining & cleaning processes for titanium bone screws and soft tissue anchors.

Developed and standardized electrochemical polishing process for surgical instruments to meet blue print specification.

Led manufacturing team to conduct process validation, PFMEA and process capability analyses Cp, Cpk.

Howmedica/ Stryker Orthopedics Rutherford, New Jersey

Senior Manufacturing Engineer July 1989 – August 2000

Led the team to develop new orthopedic implants manufacturing process and new hip stem with PMMA injection molding process. Conduct the justification and validation of major capital equipments.

Developed IO, OQ, PQ of the Mass Finishing equipment and PMMA injection molding process.

Developed and completed validation of Hip Stem Robotic Automatic Finishing Process. Developed and completed validation of Femoral Head Automatic Polishing Process.

Reviewed and approved IQ, OQ, PQ protocols, completion report and work instructions, shop travelers, for hip stem, knee, and femoral components manufacturing.

Headed project team that created an innovative Robotic Finishing Process for knee femoral component. The annual cost saving was over $333,000. For this achievement, I received the highly coveted Team Action Award of 1997.

Led a project team that redesigned the hip stem manufacturing process to eliminate unnecessary and expensive drilling anchor holes on proximal mantle. Due to this optimized process, we achieved cost savings estimated to be over $109,800 annually.

Responsible for CNC machine selection and CAD/CAM Programming for bone screw machining.

EDUCATION

MS, Bio-Medical/Mechanical Engineering, New Jersey Institute of Technology (NJIT), Newark, New Jersey 1989

BS, Mechanical Engineering, National Taiwan University, Taipei, Taiwan 1981-1985

TRAINING AND CERTIFICATION

Process Validation Engineer certification (AAMI), Quality Engineer certification (ASQ CQE )

Six Sigma Green and Black Belt Certifications ( J& J, St. Petersburg College)

Design Control, Design Transfer, Design for Manufacturing (DFM),DOE, Gage R & R

CNC Lathe, Milling, CAD/CAM, Robotic Automation, Geometric Dimensioning and Tolerance (GD&T and stack tolerance advance trainings)

ISO 14971 Risk Management, Failure Modes and Effects Analysis (FMEA)

Kaizen Lean Manufacturing, SPC, G R& R Analysis, Minitab and CAPA

ISO 13485, 14971; QSR 21 CFR 820 Part 11 Compliance (IVT)

AAMI Process Validation

MRP and Document system (Oracle, Agile, AS400,JDE)

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