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Engineer Quality Assurance

Location:
Ellington, CT, 06029
Salary:
75000
Posted:
August 16, 2010

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Resume:

Pallavi Masih

Phone: 201-***-****; E-Mail: onl6k3@r.postjobfree.com

Address: ** ***** ***, ********* ** 06029

________________________________________

Seeking an Engineering or managerial position to apply biomedical knowledge and management skills to assist in development of new product and enhance performance of the existing.

Professional Synopsis

Master of Science in Biomedical Engineering from New Jersey Institute of Technology with 3 years of experience in Medical Device industry. Presently associated with Integra LifeSciences Inc., as a Product and Development Engineer.

Academic Credentials

Master of Science in Biomedical Engineering: New Jersey Institute of Technology, New Jersey, 2006-08 GPA- 3.93/4.0

Relevant Coursework: Cellular and Molecular Tissue Engineering, Tissue Engineering, Biomaterials, BioMEMS Fabrication, Validation & Regulation in Pharmaceutical Industry, Mechanical Properties of Biomaterials, Biophysics.

Bachelor of Biomedical Engineering: Shri Govindram Seksaria Institute of Science and Technology, India GPA- 3.90/4.0

Relevant Coursework: Therapeutic & Diagnostic Instruments, Applied Mathematics & Statistics, Industrial Economics & Management, Bioinformatics, Microprocessor & Microcontrollers, Discrete Signal Processing, Applied Electronics.

Career Highlights

Organization: Integra LifeSciences Corporation, New Jersey, since May 2007

Role: Product and Development Engineer, Orthobiologics Present

 Design and develop method to incorporate bioactive glass in collagen-ceramic matrix.

 Provide information and participate in the estimation of project complexity, feasibility and cost at the concept stage of product development by working closely with marketing, quality, manufacturing and testing team.

 Gather and analyze data to benchmark and compare the performance of multiple products using specifications.

 Create and execute test protocols, DOE, Project Plan; Use historical data to develop effective test plan.

 Use Solidworks for printing 3D ceramic scaffolds

Role: Research and Development Analyst Present

 Responsible for mechanical and chemical testing of various product lines for Dural, Nerve, Skin and Bone repair.

 Very well acquainted with Instron (mechanical testing), DSC, FTIR, Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Rheometer, Ash tester, Particle size analyzer, SEM, TSC and TGA.

 Developed methods for manufacturing, packaging and process development department.

 Actively involved for validation of methods for Quality Control and Quality Assurance.

 Provided engineering support for method transfer within and additinal Integra’s facility in Puerto Rico.

 Supervise and train summer interns with current testing procedures and laboratory protocols

 Excellent organizational and writing skills for collecting data, maintaining database, preparing Standard Operating Procedures and protocols for maintenance, use and calibration of equipments with strong problem solving skills.

Role: Product and Development Intern/Co-op

 Incorporated bioactive glass in collagen ceramic matrix (MOZAIK) to improve the efficiency of bone regeneration as compared to Tri-Calcium Phosphate.

 Devised method to prepare tri-calcium phosphate in lab and other collagen and TCP based line of products, such as, morsels, putty, Bone Graft Wrap, Flowable Mozaik.

 Tool and techniques: Instron for tensile and compression testing, FTIR and DSC to determine denaturation temperature of collagen, SEM for porosity and ash content.

Master’s Thesis: Comparative Study between different Crosslinking agents used on Electrospun Type I Collagen Fibers

Description:

 Purified type I collagen from bovine tendons. Synthesized collagen fiber scaffolds by electrospinning for varying fiber diameter range and porosity of scaffold.

 Used Genipin, EDC, NHS and Glutaraldhyde for liquid and vapor crosslinking.

 Compared different techniques of crosslinking and crosslinkers with varying concentration to analyze their effect on spun scaffolds and biocompatibility by studying changes in mechanical properties, porosity, physical changes and denaturation temperature over a period of time at body temperature.

 Tools and techniques used include Instron, Scanning Electron Microscope, Thermal Gravimetric Analysis, Differential Scanning Calorimetry, Fourier Transform Infra-red Spectroscopy and chemical analysis.

Skills/Trainings (Hardware / Software Packages)

 Honored member of Tau-Beta-Gamma Society.

 Proficiency with Microsoft office software involving MSWord, Excel, PowerPoint

 Well versed with Practical Statistics using MINITAB and C++.

 Certified trained: AORN Operating room protocol and Blood Pathogen; Method Development and Troubleshooting on GC; Multivariate image analysis; Method development and troubleshooting short course on DSC & Rheometer, Guidelines to work in GMP/GLP environment; The AdvaMed code on Interactions with healthcare professionals; A Review & Understanding of the Regulatory Elements: ISO 13485: 2003, and OSHA guidelines.

 Well versed with computer aided design using Solidworks.

Other Projects

Project Title: Validation and Verification Document for Dialysis equipment

Bachelor’s Project: Cost Effective Dental X-ray machine

Certified trained from renowned hospital in India for monitoring instrumentations in Radiology & imaging, Cardiology and in immunological departments.

Summary

 Excellent time management skills. Self-starter, quicker learner, detailed oriented individual with strong communication and interpersonal skills.

 Hard-working, creative and highly motivated to work individually as well as in cross-functional groups. Excellent planning and execution skills.



Contact this candidate