SUMMARY OF QUALIFICATIONS

A diverse Engineer with leadership roles as SME and change agent in multiple manufacturing environments (Medical Device - IVDR, Pharma, Combination Products, Aerospace, Automotive, and Machine Tool). Executed (21) projects, served (15) years in corporate roles. Core expertise:

Project Management, analytical with excellent communication skills to investigate process variations, lead work streams, manage resources, analyze options/stakeholder needs, leveraging usability per IEC 62366, and structuring change management strategy in a Project Plan.

QMS, held management/supervision roles at (4) companies in (15) years, in compliance to cGMP, QSR, IVD, ISO, IEC, MSSAP, MDDAP.

R&D, New Product Development, functional & environmental testing, fixture design, control plan, design review, BOM and DHF updates.

Validation, risk-based CSV/SDLC per FDA 21 CFR Part 11, ISO 14971, IEC 62304, -62366, ISPE GAMP, ICH Q9, ASTM E2500, IVDR.

Data Integrity compliance, GxP assessment, create policy/SOP/template per 2018 FDA, UK-MHRA, EU Annex 11, ISPE, and ALCOA+.

Technology Transfer/Contract Mfg., risk-based validation/verification of injection molding tooling, Control Plan, Sampling (ANSI Z1.9), per KPIs, Risk Index, SPC/Cpk. Cost of Quality and Keizen to improve supplier capability and reduce process/dimensional variation.

Combination Products, component testing, safety, human factor studies, labeling, design V&V, usability studies for dossier tailored to specific global market for CE (EEC, EC, ICH, IEC, ISO, MDR), and FDA 21 CFR Part 11/Part 4, 210/211, ISO 13485, and cGMP 820.

Reliability Testing (HALT/HASS/HASA), Shock/Vibration/Temp, Aging, Salt Spray, Bird-Strike, Rain Erosion, Seal Integrity, EMC, RoHS compliance, and Packaging robustness. Use of APQP methodology to ensure product & process quality and reliability.

Manufacturing Process Improvement/Automation via TQM tools, set-up reduction, SPC, DOE, Kanban, Poka-yoke to reduce rejects. Monitoring using vision systems, SAP, LabVIEW, Wonderware, HMI, PLC, per GAMP5, and IEC 62366, -60601 (3rd Ed).

Certified ISO 9000 Lead Auditor, by Notified Body (TÜV), conduct audits per ISO 13485/10011/19011/AS 9100, security per ISO 28002.

Operational Excellence, apply Shingo guiding principles to align systems, select tools to achieve results, and create cultural shift within organization. Continuous improvement and enterprise alignment creates value for the customer and provides business growth.

ACCOMPLISHMENTS

End-to-End Project Management: executed multiple Cleanroom builds from concept development to permitting, utilities, environmental monitoring, production/lab/warehouse layout with A&E firms. Created URS, Commissioning, V&V protocols. (Captek Pharma, Prudential)

New Product Development & FDA Approval: completed R&D projects, helped client obtain FDA market release for Catheters. (Endologix)

Obtained ISO 9001 & 9002 Certifications: for two companies, multi sites (U.S. & Belgium) via TÜV. (Furon & Prudential Cleanrooms)

Co-Authored ISO Recommended Practice: “Flexible Packaging Materials for Use in Cleanrooms & Other Controlled Environments” for IEST organization. Chaired the IEST Working Group CC-0032 committee for (10) years.

EDUCATION

Bachelor of Science degree, California State University, Long Beach, CA

Engineering and Industrial Technology; Electronics and Quality Assurance options

Associate in Arts degree, Santa Monica City College, Santa Monica, CA

Electronics Engineering

INSTRUMENTS & SOFTWARE VALIDATED/UTILIZED

ERP systems (production control):

SAP, Oracle, JDE, QAD, LiveLink, Sharepoint, SYSPRO

QMS (CAPA, Complaint, Audit, Doc Control):

EtQ, TrackWise, Excel, Master Control, infoPV

MRP-II system software:

Oliver Wright, Statii, Global Shop, IQMS

Microplate Readers:

SpectraMax 384+/M2, Molecular Devices, Perkin Elmer Envision using StatLIA

Microbial ID system:

Vitek I and II, Biomerieux

Microbial Air Samplers (RCS):

Air Ideal, Biotest, M-Air-T, Millipore

Endotoxin Automated Microplate Readers:

ELx808, BioTek

UV-Vis Spectrometer:

Agilent 6048, Beckman 7005, Shimadzu

Gas & Ion Chromatograph:

Agilent 6890, Perkin Elmer, Dionix BIO-LC

HPLC:

Agilent 1100, Varian-Carey, Thomson, Shimadzu

Laser Particle Counter (Airborne & Liquid):

Pac Sci, PMS, Lighthouse, ARTI, Spectrex

Temperature Mapping:

Validator 2000, GE-Kaye, Honeywell SCADA

M&TE (Vision and Laser Inspection systems):

Instron, Mitutoyo, Zeiss, Sony, Theodolite, LabVIEW

SPC & spreadsheet software:

MiniTab, Datamyte, StatLIA (Branden), StatSoft, Mitutoyo, Excel, Smartsheet

SKILLS, APPLIED BODY of KNOWLEDGE

PROCESS

Sterilization methods, Injection Molding, Soldering, NASA 5300, Heat Treat, LOX Cleaning, Autoclave Coating, Seal Integrity,

TEST METHOD

HALT/HASS/Life, Accelerated Aging, Salt Spray, Packaging, ESD, Rain Erosion, Bird-Strike, Tensile & Elongation, K-Factor

QUALITY

PPAP/APQP/MSA, ALCOA+, FMEA & FMECA, Control & Quality Plans, Data Integrity, CAPA, Complaint, Design Control, GAMP

SIX SIGMA TOOLS

SPC, 8D, 5S, DMAIC, FTA, DoE, Gage R&R, Keizen, Poke Yoke, Lean Mfg.

REGULATION

FDA QSIT, cGMP 820, 210, 211, 21 CFR Part 11, Part 4, QSR 97– 4179, 803, 806, EU IVDR, ICH Q9, EN 46001, 868, 11607,17664,

FAA CFR 21, 43, 45, 145, 183

STANDARDS

ISO 13485, 14971, 9000, 10011, 19011, 11137, 14160, 17025, 10012, 17665, 15883, 14001, 25539-1, 14644, AS 9145, ANSI-Z 1.4/1.9, AAMI TIR 12,13, 30, IEC 61208, 62304, 17799, 60601

RECOMMENDED PRACTICES

IEST-STD-CC1246, RP-032, ANSI/ESD S20.20, RP-11.31, RP-22.1

PROFESSIONAL EXPERIENCE

9/2001 to Present Laguna Engineering Corp., Irvine, CA

Pharma-Biodevice Consulting (Principal QA/Engineering SME/R&D/Project Manager)

Projects are managed using augmentation approach, where resources are dedicated to the client as Engineering support, including laboratory testing. Use quality tools (APQP, Six-Sigma, 5S, DMAIC) to analyze, reduce variation, and achieve TQM goals. Typical roles and customers:

Project Management:

Technical PM using PM tools (Kepner-Tregoe, Agile, MS Project) to ensure Project Plans are aligned with needs of customer, business objectives and budget. Create Project Plans with defined scope, roles & responsibilities, phase/gate reviews, templates, Gantt charts, and dashboard as executive summary. PMP trained by Beckman PMO.

Usability Engineering, Design Control, Test Method & New Product Development:

Research electrical safety, EMC, ESD, labeling, and testing per IEC 80601/6060, and ISO 25539-1 for test method development. (Philips)

Statistical analyses of Endovascular Catheters DHF/510K submission test data using “Coefficient of Variance” formula, MiniTab and usability per IEC 62366. FMEAs (d/u/p) using Risk Index number added to Control & Quality Plans. (Terumo, Boston Sci, Endologix)

EU & China IVDR Compliance, Regulatory Submissions:

Device conformity (4 classes), gap analysis, review and restructuring of technical documents, preparation of STED per IVDR (EU) 2017/746 for submission to Notified Body/CE marking. Risk based, considering Function, Mfr.’s Intended Use, Safety, and Hazards/Risk to Patient.

Risk Based Validation & Verification:

Data Integrity compliance, GxP assessment per 2018 FDA, UK-MHRA, ISPE guidance docs and ALCOA+ principles. (Sutro Biopharma)

CSV/SDLC per 21 CFR Part 11, IEC-62304, AAMI TIR 30. Drafted MVP, FAT, SAT, and IOQ protocols. (Amgen, Baxter, Terumo)

Reliability Testing, R&D:

Respiratory Ventilator testing (HALT, HASS) per ASTM/IEC. Isolated failure/decapitation of PCBA components. (Philips Respironics)

Catheter testing (Circular Ablation, Contact Force, Deflection, Side Force, Torque, Buckle, Crossing Profile, and Irrigation). (Endologix)

Gap Analysis, Remediation:

Gap analysis post FDA audit (483, Consent Decree), or Notified Body audits, via CAPA commitments. (Zimmer, iFlow, JnJ)

Remediation of R&D Technical Reports, Design Reviews, DHF, HACCP, packaging, labeling, IFU for 510K submission. (Beckman, Endologix)

Manufacturing:

Process improvement using APQP, Six Sigma, LabVIEW, vision systems, set-up reduction, and Kanban in high volume-low mix facilities.

Use Control Plans to optimize KPIs for CNC, Injection Molding, Autoclave Coating, Heat Treat, Solder, Bond, or assembly. (JnJ, Endologix)

Packaging:

Flexible Packaging V&V per ISO 11607, ASTM, TAPPI, ISO/IEST RP-032, AAMI, EN standards. Biocompatibility testing (Seal, Leak Integrity, Air Permeability, Burst, Creep to Failure, NVR, Water Vapor Transmission, Sterilization).

CAPA, Complaints:

Structure an effective CAPA system, conduct root cause analysis using Six Sigma tools (Control Plan, 5S, DMAIC, Lean, Poka-yoke, Keizen, DOE, FTA, Gage R&R). Use MiniTab for SPC, and test for contaminants (GC/MS, FTIR, UV-VIS, HPLC, NVR).

Investigation and review of 3,000 complaints for device failure, and validity of MRB dispositions per SOPs/test methods. (iFlow, ASP-JnJ)

Cleanroom Commissioning, and Cleaning Methods V&V:

CapEx projects per ISO 14644. Selection of USP-DI Water, Environmental Monitoring, Lab systems, HVAC, TOC. (Captek, Prudential).

Cleaning Method Sterilization V&V, contamination investigations (surgical tools, implants) per cGMP 820/210/211, ISO 13485, -15883,

-14698, and IEC 62304. (Medtronic, Zimmer Spine, Zimmer Biomet)

Biocompatibility/Sterilization V&V (Gamma, Steam, EO, HP, E-beam) AAMI/ISO11137, -17664, -17665, -14160, -11607, -11135, -10993.

Supply Chain Management, Contract Mfg. Inspection:

Source qualification/inspection of suppliers and contract Mfg. (over 200, domestic/international). Use of Control Plan, Cost of Quality, SPC, Cpk, Keizen, and security per ISO 28002. Served as Lead Auditor (ISO-13485/10011/19011/AS 9100). (Prudential Labs, JnJ)

Utilized various ERP systems (QAD, SAP, JDE) and MRP-II, JIT, LPD, and Kanban to monitor/measure supplier performance & capability.

CONTRACT PROJECTS via LAGUNA ENGINEERING

Regulatory Compliance Associates, San Diego, CA (Becton Dickinson, Med Device) Validation Project Manager, 2023

Created Facility Validation Master Plan (FVMP) for BD to migrate lab/mfg/data systems from three facilities into a single operation site.

Drafted Data Integrity Risk Assessment (DIRA) template to assess systems/software, use, data storage per 21 CFR Part 11, and ISO 14971.

Endologix/PQ Bypass, Milpitas, CA (Med Device Class III): R&D Engineer, 2022

Gap analysis & remediation of Torus™ Stent Graft implant/delivery System, and EndoCross™ guidewire device for PMA submission. Created project plan for design stage gate reviews. Created Risk Management Plan, Quality Plan, Hazard Analysis, uFMEA, DMR, DHF.

Revised test plans and submitted justifications to FDA via RA. FDA market release approvals for both products issued in June 2023.

Lucira Health, San Francisco/San Jose, CA (Med Device, IVDR-Class D) Project Manager, 2021

PM for setting up two QC Labs for lot release of COVID-19 self-test device assembled at off-shore contract mfg. (Jabil in Dominican Republic)

Solved batch failure delays by substituting sampling plan using ANSI Z1.9 sampling tables, and changed batch sizes to speed-up QC release.

Vyaire Medical, Irvine, CA (Med Device, Ventilator Mfr.): R&D Project Manager, 2020

PM for Respiratory Ventilators change orders. Drafted Project Plan for IFlow™ and “+sensors”. Protocols compliance per IVDR/EU 746.

Technical PM for (3) workstreams by introducing time saving solutions for assembly, injection molding tooling, QC, and validation with suppliers/teams in China, Malaysia, Germany. Recommended mold changes to speed-up ventilator components production & distribution.

Sutro Biopharma, San Carlos/So. San Francisco, CA (Biologics, a Merck supplier, Pharma): Data Integrity Project Manager, 2018-19

Created a corporate risk-based Data Integrity policy for systems (SCADA, LIMs, remote servers, lab instruments, mfg. automated systems) per FDA & UK’s MHRA DI guidance and 21 CFR Part 11. Drafted a project plan, SOP, DI Risk Assessment (DIRA) template, and trained.

Zimmer Biomet, Warsaw, IN, (Sport Medicine Div., Implantable Devices): Sterilization SME, NPD, Project Manager, 2018

Remediation of FDA 483s for dose settings/product release. Risk based investigation of contract mfg., to reduce bioburden of new devices. Managed Sterility testing at internal/external labs and sterilizers (EO & Gamma), drafted final reports for product release.

PM for installation of infoPV™ (a web-based software to host companywide sterilization validation PQs using templates, to reduce labor).

Captek Pharma, La Mirada, CA, (Pharma, OTC Soft Gel Encapsulation): Engineering SME for a $40 million project, 2016-17

CapEx pharma build project per cGMP/ISO 14644. As Validation & Commissioning lead, created Project Plan, URS, V&V protocols, final reports, and permits from city/county/fire dept. Project phase/gate views. Verification of drawings with A&E firm and GC.

Led selection of USP-DI Water system, TOC, Kathabar dehumidification, HVAC/HEPA, and environmental monitoring system (Honeywell).

Executed machine FATs per KPIs (KEY-Symetrix vision system, Loma metal detector). V&V of Clean in Place (CIP) & Steam in Place (SIP).

Endologix, Irvine, CA (Med Device Class II): R&D/QC Engineer, 2014-15

Remediation of R&D Test Reports for regulatory submissions. Catheters (AFX, Vella, Nellix)™ endovascular aneurysm sealing systems using SPC (Coefficient of Variance) and MiniTab. For RI-QC developed Test Methods, Gage R&R, and changed manual data entry to digital.

iFlow/Kimberly Clark Healthcare, Lake Forest, CA (Med Device, Class II & III): QA-Complaint Data Engineer, 2013

Complaint evaluation (3,000 files) using EtQ/Trackwise software. CAPA investigation of elastic drug delivery pumps due to failures & 483s.

Synthes, JnJ (Universal Punch Corp), Santa Ana, CA (Contract Mfg., Med Device Class II): Supplier Project Manager, 3rd party, 2013

Retained by JnJ in Colorado to improve special process supplier (Heat Treat of surgical tools) compliance per ISO 13485. Improved supplier’s capability by Temperature Mapping using Honeywell dataloggers, process V&V, revised SOPs/Quality Manual, and training.

Zimmer Spine, Austin, TX (Med Device Class III, Implants and Surgical Tools): Sterilization Project Manager, 3rd party, 2012

V&V of chemical cleaning sterilization methods (manual vs. automated) of surgical tools to satisfy CAPA investigations and Notified Body (TÜV) audit finding. Managed Autoclave tests at Nelson Lab, UT. Validated that “manual cleaning method” per IFU was the cleanest.

Medtronic, Heart Valve, Santa Ana, CA (Med Device Class III, Implants): Sterilization/Environmental Validation Engineer, 2012

Cleaning method development for soiled surgical tools per ISO 14160 (reduced cost by substituting high temp water instead of detergents to remove biofilm). V&V of scrubbers per ISO 15883/14698. CAPA investigations of Cleanroom contamination (gowning, microbial, air).

Philips, Respironics, Carlsbad, CA (Med Device Class II): R&D Reliability/Compliance Engineer, 2011

Tested DreamStation respiratory ventilator PCBAs (HALT, HASS) per ASTM/IEC. Designed fixtures, ran vibration tests, identified weak PCBA’s surface mount components (capacitor decapitation), resulted in adding mounting bracket for small capacitors to prevent failures.

Revised Compliance doc. per regulations for labeling, packaging, safety, and IFU (QSRs, CMDR, EU MDD, JPAL, IEC 60601, -62304).

Boston Scientific, Precision Vascular, Salt Lake City, UT (Med Device Class II): Supplier QA Project Manager, 2010

Implemented a risk-based acceptance sampling method (LTPD) for Guidewire components to improve Receiving Inspection per ISO 13485.

Beckman Coulter, Brea, CA (Med Device): PMO Project Manager, 2010

Remediation of practices related to Design Control, 510K Change Submissions, CAPA, and Management Controls per ISO 13485/GMP 820.

Managed (3) workstreams using Kepner-Tregoe PM tools to monitor progress at external partners, and status of FDA Change Submissions.

Biosense Webster/JnJ, Irwindale, CA (Med Device Class II): R&D Mechanical Engineer, 2009

Catheters functional testing in R&D Lab to automate Circular Ablation, Contact Force, Deflection, Side Force, Torque, and Buckle tests.

bBraun Medical, Irvine, CA (Pharma, Combination Products, Injectable): Automation Validation Project Lead, 2007-08

Drafted MVP/FAT/SAT/IOQ for “Excel” automated IV Solution transport system (steam sterilization). Validation of HMI, pneumatics, Wonderware InTouch, PLC, I/O, conveyors, and air dryers (Automation vendor: ATS, Corvallis, OR).

Terumo Cardiovascular Systems, Tustin, CA (Med Device Class II, Wearable): Design Assurance/R&D Project Manager, NPD, 2006

Design & Process V&V of CDI-1000 Oxygen Saturation/Blood Parameter Monitoring system per IEC-62304. Reviewed Technical Reports to ensure design changes were captured in DHF per QSIT/ISO 13485. Drafted MVP, Hazard Analysis, FMEA, URS, IOQ, PQ protocols.

Advanced Sterilization Products/Ethicon/JnJ, Irvine, CA (Med Device Class II): Production Component Engineer, 2005

Tested STERRAD™ sterilization system components to aide daily MRB. CAPA investigation, FMEA, and software V&V.

Investigated component failures (Power Supplies, PCBA Photo Sensor) at suppliers and facilitated process improvement & corrective action.

Amgen, Bothell, WA (Biotech CRO, Combination Products): Validation SME, 2003-05

Risk based gap analysis of ~1,300 lab systems/software/data servers. Validation per 21 CFR Part 11/GxP. Developed protocols and test scripts for systems (Microbial ID, Endotoxin, Plate Readers, StatLIA™ statistical software).

Assay R&R to identify variance of data calculation between legacy vs. new systems after each system upgrade (Absorbance (ELISA),

Time-Resolved Fluorescence (LANCE, DELFIA), Fluorescence Polarization, Fluorescence Intensity (Cell based & Binding)

Baxter BioScience, Thousand Oaks, CA (Aseptic Processing, Pharma): Validation Engineer, 2003

Validation of Cimplicity™ Asset Manager server, AB -PLCs per FDA 21 CFR Part 11. Developed & executed IQ/OQ protocols.

Schering Plough Healthcare Products (Aseptic Processing, Pharma): Validation Engineer, Lab Systems, 2002

FDA consent decree remediation & validation of R&D lab instruments, stability chamber, water delivery system used for Mfg.

5/1995 to 9/2001 Prudential Cleanroom Laboratories, Irvine, CA

Corporate QA Manager

Managed (5) contamination control/cleanroom labs in CA, AZ, NM, TX, and VA. Hired, trained, and managed (11) Auditors/Technicians.

Cultivated a corporate wide ISO 9000 based documented system. Obtained ISO 9002 certifications via TÜV America.

Planned budgets, facility upgrades, and networked data collection from (5) labs (environmental monitoring, ESD, microbial ID, sterility testing).

Instituted an effective CAPA/Complaint system, guided internal audits & Management Reviews. Investigated customer complaints such as skin irritation, or product quality issues. Tested using IC, GC/MS, FTIR, UV-VIS, HPLC, NVR methods to identify root cause(s) at external labs.

Negotiated and reduced irradiation cost using Control Plan/JIT, eliminated safety stock (a saving of $260K over 5 years). (SteriGenics)

Source qualification, audits of specialty fabrics and consumable products suppliers (gloves, face masks, wipes, cleanroom supplies in Japan/U.S.).

Led MRB meeting to evaluate supplier related nonconformities. Improved supplier performance by using Defect Code, Control Plan, and SPC.

5/1992 to 3/1995 Furon, Mechanical Seal Division, Los Alamitos, CA

Supplier Quality Engineering Supervisor

An engineered PTFE Teflon/Polymer/Metallic Spring Energized Seals Mfr., serving Automotive/Aerospace/Medical Device.

Supervised (45) direct/indirect auditors, inspectors, and QEs. Improved incoming inspection using SPC, Control Plan, and supplier audits.

Obtained ISO 9001 certifications, (2) sites in CA and TX. Cultivated ISO 9000 culture/team building.

Utilized MRP-II, Six Sigma, JIT, APQP which improved on time shipment by 30%, and inventory reduction by 55% ($650K saving).

Prepared PPAPs for automotive clients (GM), and inspection forms for aircraft engine mfr. (General Electric, Pratt & Whitney).

Failure investigation of PTFE seals surface cracks using Instron, optical comparator, dye penetrant, X-ray. Life-reliability testing of LNG

loading arm seals installed in Nigata, Japan. Redesigned packaging & installation aides to eliminate surface cracks. ($50K scrap reduction).

11/1989 to 5/1992 Swedlow (Pilkington Aerospace), Garden Grove, CA

Sr. QA Engineer

Mfr. of coated Polycarbonate, Acrylic, Glass, and Composites serving Aerospace/Automotive OEMs.

Maintained QA system per AS9100, process improvement using Six Sigma tools (Lean, SPC, JIT, MRP-II, FMEA, DoE).

Failure analyses of coating crazing (micro cracks) using DOE/ANOVA to isolate the root cause. Eliminated $120K rejects/month.

Environmental testing of aircraft windshields/canopies (autoclave coated Polycarbonate/Acrylic), Bird Strike, K-factor, Rain Erosion, ESD,

Adhesion Bond, and Optical properties (F/A-15, B1-B, B-2, A-10, F/A-18). Drafted test reports for submission to prime/DoD.

Tooling inspection using Theodolite Laser measurements for composite components (Torpedo, Rocket exit cone, Ship shroud).

6/1985 to 11/1988 Southwestern Industries, Los Angeles, CA

Industrial Engineer/QA Manager

A CNC automation, Digital instrumentation, motion control Mfr. serving Machinery/Automation/Aerospace.

Established and manage QMS. Trained and supervised (14) technicians per NASA 5300, - 8739.3 soldering spec.

Reliability testing (vibration/shock/heat). Designed test fixtures for CNC motors/PCBA testing to detect system failures by accelerated motion control algorithm testing. As a result, reduced field rejects by 80% ($24K/month), reduced cycle time by 35%, and improved safety.

Supply chain audits, training and Control Plans to boost supplier’s QC, and improve special process quality (passivation, plating, welding).

Researched and recommended material substitution (compounds and adhesives) used in Pressure Switches for Atlas & Delta Rockets. Conducted functional testing and drafted test reports per Mil-STDs and ASTMs for approval to prime. (Rocketdyne).

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