Project Engineer Resume

OBJECTIVE
To obtain position in medical device field where I can apply my skills in engineering

SUMMARY

5+ years of experience in mechanical design and development of medical devices
Worked as project lead and experience with design control procedures, engineerinand statistical analysis, mechanical testing and developing test methods, CAD tools, technical protocol and reports
Solid leadership, teamwork and project management skills

WORK EXPERIENCE

Confidential, Orangeburg, NY 08/08-11/10
Project Engineer

Worked as project lead for new and existing wound care products from design concept to launch
Generated project plans and executed activities with multi-functional teams from QA, regulatory, sales, marketing and manufacturing in accordance with agreed upon timelines.
Successfully completed projects from initial product design stage to design transfer using FDA part 820 guidelines
Created design verification, validation, clinical reports and conducted design reviews with all required functions
Generated test protocols, reports, test methods with lab personnel, carried out lab experiments, analyzed test results using statistical tool Minitab15.
Participated in internal and supplier audits to assure compliance with FDA requirements, GMP, ISO quality standards and internal SOP\'s.
Created risk management files in compliance with ISO14971 by performing risk analyses
Created or reviewed IQ/OQ/PQ validation documents and conducted in-house validation runs
Co-ordinated and participated in in-house manufacturing runs for quality or process improvement projects
Identified and qualified suppliers for product testing to minimize production cost
Created and maintained design history folders in compliance with FDA part 820 guidelines
Represented R&D for developing and revising documentation and procedures required for release of finished goods and regulatory submissions.

Confidential, Franklin Lakes, NJ 07/07- 07/08
Research Engineer

Successfully drove projects to completion on time
Created project plans using Microsoft Project and executed projects with cross-functional team including representatives from Quality, Manufacturing, R&D, Regulatory and Medical Affairs
Represented R&D group for CAPA project implementation
Authored Design Verification documents and performed verification testing of injection molded needle products
Designed test fixtures using Solid works 9.0, developed test method and executed tests using Instron machine
Performed Design of Engineering Studies and statistical analysis of data using Minitab 15.0
Provided Finite Element Analysis solutions for development of product specifications
Proficiency in writing technical protocols / reports and test protocols / reports
Reviewed IQ/OQ/PQ validation documents with manufacturing group
Created Failure Mode and Effects Analysis (FMEA) documents, Measurement System Analysis (MSA), product part and assembly drawings, Buy specifications, Engineering Change Order (ECO) documents to release products
Developed documents per medical device design control procedures in compliance with 21CFR Part 820 and maintained records in Design History Folders

Confidential, Mahwah, NJ 07/06- 07/07
Advanced Technology Department – Tribology Lab
Research Assistant

Worked on wear analysis projects of prosthetic joint implant bearing materials and lubrication conditions
Performed wear tests and analyzed test results using Microsoft Excel
Performed friction testing of implant materials using Orthopod
Assisted project engineers with concept development research projects
Experience in using wear simulators for hip and knee components (femoral heads, acetabular cups, femurs, patella, knee inserts)
Designed prototypes of instruments using ProE Wildfire 2.0
Modified old drawings in ProE Wildfire based on design change requirement
Responsible for maintenance and troubleshooting of lab equipments

Confidential, Cedar Grove, NJ 07/05 – 07/06
Engineering Intern

Worked on design modification project on ProChamber valve with cross-functional engineering team.
Executed test methods to verify compliance of respiratory medical devices like Full range and Half range peak flow meters, OptiHaler, OptiChamber devices with American Thoracic Society (ATS) and European standards.
Created and maintained engineering reports and protocols.
Involved in manufacturing of medical device prototype using CGMP guidelines.

EDUCATION

SKILLS
Computer Skills

Certification training course on Auto Cad and Pro/Engineering Wildfire 4.0 from Cadd Center, October’2011
Mechanical Design using Solid Works 9.0, Pro/Engineering Wildfire 2.0, Pro/Mechanica
Statistical analysis using Minitab 15.0 and Excel
Microsoft Project

Instrumentation Skills

Experimental testing by Instron machine, Interferometer, Contact Angle Measurement instrument, Coordinate Measuring Machine, Electrospinning machine