Project Engineer
Resume:
Michael George
Vista, CA 92081
************@*****.***
Profile
* Experienced Mechanical Engineer with nine years of project development and management.
* Professional experience with FDA regulations, QSR, ISO 13485 & 9001, cGMP, and design control.
Experience summery
* Develop classes I, II& III implantable devices and associated surgical instruments through all phases of design control.
* Develop and manage next generation of implants driven by VOC and market study.
* Create dynamic designs accommodating all possible variations to generate multiple revisions.
* Create detailed manufacturing drawings emphasize on GD&T and ANSI.
* Administrate IntraLink and Pro/E. Propose and assist in system upgrade & customization.
* Test various materials (plastic & metal) and designs to achieve the desired performance.
* Plan, schedule and coordinate detailed phases of projects
* Lead cross function product development team of marketing, QC, manufacturing, and regulatory to manage product development.
* Manage project progress from concept to production including design verification & validation, suppliers, prototypes, bench tests, cadaver labs, biocompatibility test, and PQ.
* Create and maintain all project DHF documents according to the FDA regulation requirements.
* Search for new technologies and validated a new manufacturing method (Metal Injection Molding) that would save 68% of some products’ production cost.
Caldera Medical Project Engineer Agoura Hills, CA 08/09 – 04/10
Caldera’s minimally invasive medical implants address the SUI and Pelvic Organ Prolaspe.
Orthofix Mechanical Engineer McKinney, TX 09/06 – 06/08
Orthofix is an innovative company in the medical device field with a unique line of products.
Stryker Mechanical Engineer Mahwah, NJ (consultant) 03/05 – 07/06
Stryker Corporation is a worldwide leader in the orthopaedic and medical device market.
DRS Communications Mechanical Engineer Wyndmoor, PA (consultant) 11/03 – 03/05
DRS Communications develops advanced aerospace products for the DOD.
* Developed the mechanical structure of a new Radar system from a proposed concept and populated the antenna with wave control devices.
* Designed DTS-K box structure and populated it with electronic equipments and PCBs
* Conducted structure and thermal analysis to optimize design and operational performance.
* Created and maintained BOMs, ECNs, and detailed drawings.
* Applied Military, GD&T, and ANSI standards. Released drawing for manufacturing.
ITT Industries Mechanical Engineer W. Caldwell, NJ (consultant) 07/00 – 09/03
(PCI-Wedeco) PCI is a leader in Designing and manufacturing ozone generators for water treatment.
* Researched and analyzed customer specifications and parts’ manuals to determine the design approach and system configuration.
* Modelled ozone systems in Pro/E and maintained IntraLink.
* Created manufacturing drawings with emphasize on ANSI and GD&T.
* Conducted design review and released design documentations for fabrication.
ITT Industries Mechanical Design Engineer Clifton, NJ
ITT is a major military supplier for the aerospace and aviation programs among other numerous military and industrial applications.
* Finalized a preliminary design of a GPS box for an aerospace program.
* Designed chassis and packaged electronic equipments to optimize operational performance.
* Created and maintained ECN, BOM, and fabrication drawings emphasizing on military standards and GD&T.
Education New Jersey Institute of Technology (NJIT) Newark, NJ May 2000
BS in Mechanical Engineering Technology
Computer Skills
* Pro/E wildfire 4.0 (10 years), SolidWorks, and UG
* IntraLink, PDM, and Windchill
* FEA analysis: COSMOS, Pro/Mechanica, and ANSYS
* MIMICS
* MS Office, MS Project
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