Log in

Login to your account

Username *
Password *
Remember Me
Loading...
Show More
Add this resume to contact form Yes No
Back to Search Result GO

Medical Device Material Science Expert (Polymers, Plastics)

Technical Consultant #2048


Expertise

  • Product development from concept to market.
  • 21CFR820 (cGMP) and ISO13485 QSR.
  • Polymers and materials for medical devices.
  • Vascular and catheter systems.
  • DOEs and process optimization.
  • Process Validation (IQ, OQ, PQ).
  • Medical device design control process.
  • EPA, FDA, REACH and RoHS compliance regulations.
  • Fluoropolymer and lubricious coating components used in the medical devices.

Experience

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.

Honors & Publications


Languages

  • Farsi

Publications and Patents

  • Author of several publications in peer reviewed journals.
  • 2 U.S. patents

Education

  • M.B.A. University of Phoenix, San Jose, CA
  • Ph.D. Polymer Science, University of Akron, Akron, OH
  • M.S. Physiology, University of Akron, Akron, OH
Back to Search Result GO