Medical Device Material Science Expert (Polymers, Plastics)

Technical Consultant #2048

Independent Consultant, 2010 - Present

Fluoropolymer and lubricious coating components used in the medical devices.
Market research and product concept feasibility assessment for embolic coils.
Investigated conductive and dielectric conformal coatings in RF catheter ablation devices.
Identified and corrected the root causes for the contaminants in the manufacturing process, the wire coating flaking/delamination and the component bond strength/adhesive issues.
EPA, FDA, REACH and RoHS compliance regulations.
Material selection and proof-of-concept evaluation.
Device design change and material risk assessment.
Polyurethane accelerated aging evaluation.
LDPE (Low Density Polyethylene) material replacement and shelf-life stability assessment.
Nylon 12 (Pebax and Grilamid) bond joint and composite lamination assessment.
Test method development and testing (mechanical, biocompatibility and sterilization).
Conducted sterilization process validation (per ISO11135-1).
Issued test protocols, reports and rationales.
Supported and provided documents for the California FDB (Food and Drug Branch) and GMED audits.
Established the sample size needed for the Lot Release (per ANSI/ASQC Z1.4).
Quality Assurance: Nonconforming materials investigations and LHR reviews.
Supplier management: evaluated supplier qualification and maintaining the ASL (Approved Supplier List).

Nellix Endovascular, Palo Alto, CA, 2008 - 2009

Material selection and device design: worked with ePTFE,( polytetrafluoroethylene) polyurethane and PEG (polyethylene glycol ) hydrogel systems.
Prototype design, development, testing and documentation (protocols and reports).
Conducted supplier qualifications: Established material specification, conducted 1st article inspection and performed vendor audits.
Reviewed and interpreted experimental data, presented results and made recommendations to the cross-functional team members and management in a design review process.
Experience in support of regulatory submissions.

Medtronic Vascular, Santa Rosa, CA, Principal Engineer, 2007 - 2008

Material selection, characterization and testing: Investigated materials, such as woven PET, Dyneema (UHMWPE), PEEK, ePTFE, FEP, PVDF, PUR, Silicone, EVA, and Nylon 12.
Familiar with medical textile processing and materials: woven, braided and knitted structures.
Experience with coating, heat shrinks, UV curing adhesives and bonding techniques.
Performed method development, prototyping and analytical testing.
Performed component and device testing (e.g., permeability, tensile, puncture fatigue, loading, radial force, packing efficiency, torquability, and component bond testing).
Experience with marketing research and competitive product analysis.

W.L. Gore & Associates, Flagstaff, AZ, Project Leader and Manager, 1997 - 2005

Project Leader for stretch vascular graft components development.
Verification/Validation - Experience with design control process components, such as design input, output, verification, risk analysis, FMEA, and validation.
Utilized statistical methods for DOEs, control charts, process capability and analyzing data.
Knowledgeable in computer software, such as Minitab, SolidWorks, MS Project and Visio.
Performed intellectual property evaluation of various materials and processes.
Project strategy planning and budget/resource allocations.
Utilized project management and prioritization tools, such as MS Project and Gantt Charts.
Experience in support of regulatory submissions (510K, IDE, PMA addendum, Masterfile).

Material Development Manager

Hands-on experience with formulation, development, characterization and processing of materials, such as bioabsorbable polymers (e.g., PLGA, PLA/TMC, PGA/TMC) and fluoropolymers (e.g., PTFE homopolymer and copolymers).
Investigated various composites (e.g., blends, co-coagulates, polymer/metal, film laminates, and imbibed tubes/sheets) to understand material structure/property interactions.
Developed and validated test methods to study aging effects and stability of materials, measure suture hole leakage, quantify drug byproducts, copolymer compositions, and contaminants.
Experience with processing equipments, such as conical reactor, pelletizer, melt extruder, calendaring, 2-roll mill, compounding, thermoforming, transfer molding, longitudinal and transverse expanders.
Experience in using mechanical/analytical equipments, such as tensile, fatigue and abrasion tests, ODR, MFI, DMA, TGA, IV, SEM-EDX, FTIR, NMR, GPC, GC, HPLC and DSC.
Worked with external researchers (academic), suppliers and contract labs.

Project Engineer: Membrane development, coating and drug eluting stent applications.

Developed thin film coatings from bioabsorbable, hydrophilic, and fluoroelastomer materials.
Impregnated polymer materials with other polymers (e.g., silicone and PU), antimicrobial agents (e.g., Ag2CO3 and chlorhexidine diacetate) and drugs (e.g., dexamethasone).
Developed non-porous ePTFE/FEP composite membranes.
Actively involved in three product developments: Cardiovascular patch, Dura Mater Substitute and Bioabsorbable SeamGuard Staple Line Reinforcement Products.
Worked with fluoroelastomer material/device design for finger joint arthroplasty project.
Worked with nitinol scaffold design of second generation TAG Endoprosthesis.
Managed scale-up efforts and technology transfer to production of materials.
Completed a number of disclosures, work plans, protocols, and reports.

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Publications and Patents