Project Management Medical Device

Program & Project Management:

Proven leader with over 24 years of experience in the Class-III medical device industry, specializing in manufacturing, quality auditing, and product design development. Expertise in validation oversight, regulatory compliance, and process improvement. Adept at ensuring adherence to GxP standards (GMP, GDP, GCP) and leading validation efforts across equipment, critical utilities, automation, cleaning, and process systems. Strong background in approving validation documents and ensuring alignment with FDA, ISO, and global regulatory requirements. Ensure High-Quality Products for Global Markets, Project Management to launch, leverage diverse in-house & external implantable medical device manufacturing, quality & product design development experience to achieve business goals. Enable commercial product launches based on 21CFR7, 21CFR820, 21CFR803, 21CFR806, ISO14971, QSR820, ISO14001, ISO13485, ISO11979, and ISO10993, AS9100 and EH&S risks and SAP & MES. Collaborate with internal & external stakeholders to achieve shared business goals. Identify improvement opportunities & promote continuous 6-Sigma mindset. Patents granted for numerous Medical Device Delivery tools.

Collaborated with across functional departments to identify streamline processes, ramped up production to exceed revenue goal. Led and contributed to the overall health of an organization through development of production goals and improving workflows for different departments. A visionary leadership with a proven track record approaches in helping employees engaged, valued, and challenged in the right direction without compromising the company's short- & long-term objective goal. SME in Process & Product Transfer to low-cost center.

CORE COMPETENCIES INCLUDE:

Design Control Risk Management Six Sigma Production Launch Supplier Relations Team Management & Training GRI Corrective & Preventative Actions (CAPA) Problem Resolution Process Optimization Hot runner micro-Injection & extrusion molding Process Validation DTM EH&S Master Validation Plan/Report SCAR IQ/OQ//PA FA TMV Reliability Testing, GxP Auditing (GMP, GDP, GCP), Quality Oversight & Compliance, Risk Management, Supplier & Manufacturing Audits Master Validation Plan/Report Approval Regulatory Submissions & Technical File Review Supplier Sourcing specialist Facility Layout optimization Project Management

PROFESSIONAL EXPERIENCE:

Integralife Lifesciences Started 10/2024

Staff Design Assurance and Reliability Engineer:

Subject Matter Expert (SME) for continuous improvement of Risk Management/Human Factors through end of product lifecycle.

Support New Product Development (NPD) and Continuous Sustaining Engineering.

Subject Matter Expert (SME) on Vendor Sourcing, Non-conforming, CAPA, Process Validation, TMV, and Design Verification

AccuPulse (Contract Ended) 06/2024 – 10/20/24

Design Quality Engineer / Supplier Sourcing Specialist: Irreversible Electroporation (IRE) Catheter & Navigation Catheter

Led supplier designs in comparison with requirements and specifications and collaborated with suppliers in validating, improving IQ/OQ/PA/FA, GR&R, Cpk, and documenting process control plan for high-risk component and quality sourcing along with review and approve Supplier Agreement along with Contract Negotiation.

Led Supplier production capabilities and plans to meet commercial delivery requirements.

Led alternative design and manufacturing resource for US/China.

HydraFacial Medical, Long Beach, CA (4 Indirect Report) – Laid off due to downsizing 07/2023 – 06/2024

Program Technical Manager, Research & Development/Supplier Quality and Validation

In charge of executing six phases of Design Control for Design and Development of Class I and II Medical facial Medical Device along with process Validation/Improvement, Clinical Output, Supplier Qualification, Submission, Site Audit, and remediation.

JOHNSON & JOHNSON, Irvine, CA (1 Direct report & 10 Indirect reports) – Laid off due to downsizing 06/2016 – 04/2023

Staff Quality/Process Engineer Program Lead for New Products Research & Development/Supplier Quality and Validation:

Oversaw 4-seconds ablation, navigation, and ultrasound catheters, and cables quality through design control 6-phases (1 direct /4 indirect reports), including drawings, design changes, supplier chain, risk management, CAPA, SCAR, Quality Program internal/External audit, process characterization, clinical studies, production launches, supplier audit / qualification, and Lean 6-Sigma, vendor process and qualification improvement on machine, tumbling, Lead Master Validation Plan/Report closure for manufacturing new product launch, hot runner injection molding micro-component, compression molding, extrusion molding, wire forming, and PC board.

Enabled ablation catheters and cable approval in United States, Canada, China, Japan, Europe, and Russia.

Served as an SME for all equipment validation from chemical/gel mixing, PU bonding, welding, curing, laser/resistance welding.

Collaborated with suppliers in validating, improving IQ/OQ/PA/FA, GR&R, Cpk, and documenting process control plan for high-risk component and quality sourcing along with review and approve Supplier Agreement along with Contract Negotiation.

Led Franchise NPD/R&D groups in selection, evaluation, qualification of supplier of material and services.

Developed new market domain assessment and recommended optimal domestic and international business in partnership with marketing team through clinical protocol/report and system validation to meet the End to End output using SAP & MES.

Partner with procurement category teams & Senior R&D leaders to identify unmet need to drive sourcing strategies & innovation.

Launched $1B+ products by leading teams and projects through research and development (R&D), clinical studies, manufacture validations, and supplier qualifications. Support targeting and planning for launch of catheters for market penetration in EU/China.

Served as SME with RA for technical files submission of Design Testing reports for approval of US, Europe, China, Russia, Japan.

Reviewed and approved all related Mechanical and Electrical drawings for product transfer from Irvine, CA to Juarez, Mexico

Optimized quality, supply reliability, innovation and cost through early supplier engagement during product development

TERUMO, Ann Arbor, MI – Contract Ended 07/2014 – 04/2016

Validation Engineer Program Lead/Supplier Validation (Consultant) for Cardiovascular Perfusion Heart & Lung Machine:

Assisted in having consent decree lifted for perfusion hear and lunch machine (Phase-1). Completed validation activities for perfusion heart and lung machine related to consent decree (Phase-2). Managed 10 indirect reports (contractors) to validate test method, EH&S risks along with Master Validation Plan/Report. Responsible for SCAR, Quality Program internal/External audit, TMV, Process Characterization, Supplier Agreement.

Improved acceptance criteria by updating work instructions, drawings, procedures, & validation process streamline with vendors.

Performed over 30 TMV for micrometer, caliper, dial indicator, height gage, air gage, torque, concentricity gage, laser mic, dial indicator, and accelerometer. Managed and trained new validation engineers in new product qualifications (IQ, OQ, PQ, TMV, DOE) and risk analysis (design failure mode effective analyses [dFMEA], pFMEA).

Revised procedures, work instructions, and machine process remediation, resolving and closing internal and external CAPA.

TYCO ELECTRONIC MEDICAL, Wilsonville, OR – Contract Ended 03/2014 – 06/2014

Principle Validation Engineer Program Lead/Supplier Validation (Consultant):

Assisted quality engineer, R&D engineer, and production managers to resolve FDA medical device wire braiding and extrusion process validation findings and EH&S risks, hot runner injection molding, compression molding, and wire extrusion molding

Performed DOE, installation qualification (IQ, OQ, product qualification (PQ), and TMV on wire braiding /extrusion process. Resolved and closed out CAPA through revise procedures, work instructions, machine process remediation, and validation.

Senior Validation Lead Engineer/Supplier Validation (Consultant)

Supported Crystalens Intraocular Lenses (IOL) market delivery.

Validated processes and updated procedures, forms, Silicone compression Molding and packaging validation.

oHaptic tumbling process for use in Crystalens manufacturing and ultrasonic cleaning process for caps and cases used for Crystalens packaging along with in-process pouch peel test for used in final Crystalens packaging.

oGlassware and tools for ultrasonic cleaning process used for Crystalens manufacturing.

BAUSCH + LOMB, Aliso Viejo, CA – Corporate buyout 01/2013 – 12/2013

Sr. Quality Engineer Program Lead for New Products Research & Development/Supplier Quality and Validation:

Released Crystalens IOL, Trulign Toric, and reusable injector through collaboration with R&D, production, process validation, Master Validation Plan/Report, supplier audit and qualification (4 indirect reports).

Validated and approved supplier injectors and cartridges for use in IOL delivery systems and CAPA support and closure.

Performed internal / cooperate audit and remediation for DHF, DHR, clinical build, and supplier; reported to management.

Reviewed and approved design inputs, outputs, and validations for lens fatigue and rotation stability testing.

Calibrated systems utilized in research and development equipment for lens fatigue analysis.

Developed quality reports and risk management plan and reports and conducted dFMEA, EH&S risks & pFMEA for IOL.

Created new domain market assessments and recommended optimal global business in collaboration with marketing team.

Served as quality lead for complex teams and projects across manufacturing, R&D, supplier test lab, and product launch for billion-dollar products to meet the End to End Supplier & responsible for Contract Negotiation Agreement closure with suppliers.

Collaborated with market to pinpoint targeting and planning for launch of IOL lens for market penetration in US/EU/China

Responsible for TMV, SCAR program, Quality Program internal/External audit, Supplier Agreement, Process Characterization.

Approved procedures, drawings, and work instructions for design transfers to manufacturing, enabling product launches

ABBOTT LABORATORIES, Irvine, CA 01/2012 – 12/2012

Senior Process/Manufacturing Program Lead and Supplier Quality:

Released Safire Blue ablation catheters and executed Lean Six Sigma cost saving for new / existing products (4 indirect reports).

Resolved catheters locking and bend angle issues through reflow, wire braiding, and extrusion process improvement.

Validated and audited supplier components for use in new products, reducing cost through design improvement.

Responsible for Franchise NPD/R&D teams for the selection, evaluation, and qualification of supplier of material and services.

Resolved ablation catheter planarity issue through braiding and extrusion process enhancement.

Performed DOE, installation qualification (IQ), operation qualification (OQ), product qualification (PQ), and TMV for product transfer and remediation & EH&S risks.

Served as an SME for all equipment validation from chemical/gel mixing, PU bonding, welding, curing, laser/resistance welding.

Optimized quality, supply reliability, innovation and cost through early supplier engagement during product development

Responsible for Quality Program internal/External audit, SCAR program, TMV, Process Characterization, Supplier Agreement.

Worked with procurement category teams & Senior R&D leaders to identify unmet need to drive sourcing strategies & innovation.

Lead and closure of MVP/Report for all equipment in manufacture through using SAP & MES.

Led & approved all related Mechanical and Electrical drawings for product transfer from Irvine, CA to low cost center

Remediated risk management files (dFMEA, pFMEA, aFMEA) and created risk management plan and report.

Supervised technicians in performing process validations for new product launches and customer complaint investigations.

EDWARDS LIFESCIENCES, Irvine, CA - Laid off due to downsizing 01/2008 – 12/2011

Staff Process Manufacturing/Supplier Quality Engineer: Supported launch, production sustainment, & low-cost center transfer to Singapore & Switzerland for heart valve stent & heart valve repair ring, including tissue fixation & biocompatibility testing (3 indirect reports).

Performed DOE, installation qualification (IQ), operation qualification (OQ), product qualification (PQ), and TMV.

Maximized output 30% through Lean Six Sigma manufacturing line extension process improvements.

Validated new and back-up equipment through installation, operational, and process qualifications for CAPA closure and dFMEA and pFMEA remediation and EH&S risks and review and approve Supplier Agreement.

Worked with RA for technical files submission of Design Testing reports for approval of US, Europe.

Approved procedures, drawings, and work instructions of design transfers to manufacturing for product launches.

Improved cycle time 15 – 20% by redesigning wire forming automation for heart valve and ring repair.

Performed root cause analysis, interfacing suppliers & subcontractors to resolve quality complaints & validate compression molding.

Led product transfer team to low-cost center by improving SOPs, Mechanical & Electrical drawings, procedures, and operation consolidations, which resulted in $2M annualized saving for high-volume silicone compression molding and ring repairs.

Optimizing glutaraldehyde and Formaldehyde -fixed tissue heart valves with chondroitin sulfate hydrogel for endothelialization and shield against deterioration.

Served as an SME for all equipment validation from chemical/gel mixing, PU bonding, welding, curing, laser/resistance welding.

ADDITIONAL RELATED EXPERIENCE BEFORE 2008:

ABBOTT LABORATORIES., Sylmar, CA Design Quality Assurance Engineer Lead

Qualified and released implantable pacemaker leads, cardioverter-defibrillator leads, and cardiac resynchronization therapy and used nitinol, hot runner silicone injection and extrusion molding and robotics to optimize manufacturing process & EH&S risks.

Reduced tooling cost 70% by using bendable Nitinol material instead of stainless steel in assembly process.

Led process Six Sigma improvement through using systems SAP & MES.

Reviewed & approved all related Mechanical and Electrical drawings for product transfer from Sylmar, CA to Sweden & Puerto Rico.

SEALS METHODS INC., Santa Fe Springs, CA Quality Manufacture Engineering Manager

Achieved ISO 9001 certification and supported new product launch for existing medical and non-medical adhesive products.

FCI ELECTRONICS INC., Cypress, CA Senior Quality Engineer

Qualified new medical cables for use in medical device equipment, including ablation and ultrasound catheters & EH&S risks.

GLENTEK INC., El Segundo, CA Quality Engineer Lead

Qualified and supported production for alternation and direct current motor and PC board assembly into amplifiers products use in Aerospace, Hospital, Satellite, Medical Surgery, and aircraft.

CHATSWORTH PRODUCTS INC, Chatsworth, CA Quality Engineer Program Lead

Achieved ISO 9001 certification and supported new product launch and existing file server and network cabinet products.

EDUCATION

Bachelor of Science (BS), Industrial and Systems Engineering (ISE), University of Southern California (USC), Los Angeles, CA

SOFTWARE AND LANGUAGE SKILLS

Team Center, Windchill, Minitab, Catsweb, IMAN, Blue Mountain, Documentum, Kintana, Compliance Wire, QP3, Matrix, SAP & MES

Desktop Software: QMS System, AMS Windows, Agile, Word, Excel, Visio, Access, Microsoft Project, Master Control

Multilingual (Fluency): English (100%), Teo-Chew (100%), Cantonese (80%), Vietnamese (30%), Mandarin (20%)

Microsoft Project (MP) Management for all project own.

PROFESSIONAL CREDENTIALS

Green Belt Six Sigma (certified); Black Belt Six Sigma (trained); Lean and Mistake Proof Orange Belt (certified)

Design for Technology (DFT) / Design for Manufacture (DFM); Internal Auditor, Internal Root Cause Investigation (certified)

PATENT ACCOMPLISHMENTS:

Abbott Laboratories (US 8170692 B2) MAY 01, 2012:

Active Fixation Delivery Device for Pacemaker and Defibrillator Leads

Eliminated active implant fixation lead over-torque, which minimized dislodgement and perforation.

Abbott Laboratories (US 8747417 B2) JUN 01, 2014: Device and Method for the Implantation of Active Fixation Leads

Allowed for easy delivery of active implantable medical device leads for pacemaker and defibrillator.

Abbott Laboratories United States Trade Secret Granted (for use in manufacturing process of pacemaker and ICD leads)

Improved the manufacturing process, tooling usage, and product reliability performance.

Johnson & Johnson (US/25.06.19/USP201962866109) 2024: Catheter Deflection System with Deflection Load Limiter

Eliminated broken and overloaded puller wires during ablation and final catheter withdraw.

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