Engineer Project Manager

MICHAEL H. VARDANEGA

*** ****** ******* *********, **. 94513 Cell 925-***-**** ************@*****.***

OBJECTIVE

Results oriented Senior Project Engineer with hands-on experience in medical device Project Management, and Mechanical Design. Creative thinker at solving complex problems and adept at driving projects to completion. Acquired solid engineering skills with strengths in prototype development, fabrication, testing, and manufacturing with team validation and verification responsibilities. Looking for a challenging engineering position in a team environment with a growing company where my passions and commitment to excellence can be fully utilized effectively for the benefit of both of us.

CORE COMPETENCIES

Gained good verbal/written comunication skills to write set-up and assembly procedures for technician training, qualify vendors and maintain the Design History Files (DHF). Proficient in SolidWorks for mechanical part design to produce part and assembly drawings. Work with the Customer, Quality Assurance, and Manufacturing to ensure the design outputs meet the design inputs. Well organized to handle multiple projects simultaneously. I developed time management skills and data presentation using MS Office, PowerPoint, Excel, MasterControl, SysPro, SAP, Agile, and PDM.

PROFESSIONAL EXPERIENCE

Stryker NV Corp. Fremont, CA. 2011-Present

Sr. Equipment Engineer (Contractor)

Leads equipment project teams coordinating efforts of engineers, technicians, and other disciplines and departments to design, develop, and continuously improve medical device products. Independently performs work which involves equipment investigations to find failures and make improvements; performs all equipment re-validations as required.

DSM Biomedical Inc. Berkeley, CA. 2007-2011

R&D Device Project/Process Engineer

Research, develop, plan, and design device components and their related manufacturing equipment. Develop tooling and fixtures for DSM PTG’s implantable medical devices. Serves as engineering liaison between Device R&D and Manufacturing.

Major Accomplishments:

• Designed an injection molded blood filter housing for ExThera Medical LLC’s Seraph Treatment Column. All design inputs met the outputs per the customer’s request.

• Designed all related manufacturing tooling and fixtures, wrote all assembly procedures, set-up of the manufacturing process and trained technicians in a cleanroom environment

• Designed a loading fixture to accurately place 12 Nuclei on the rack prior to dip coating

• Improved accuracy of the dipping station with and an optical encoder and a digital read-out. Documented all process improvements and parameter settings, and maintained process equipment in our PM system

TYCO HEALTHCARE Inc. Pleasanton, CA 2000-2007

Sr. Project Engineer, Mechanical Designer Engineer: Critical Care Systems R&D

Major Accomplishments:

• Project Manager and Lead Engineer responsible for the WarmTouch® Product Line. Performed numerous Root-Cause-Analysis’ on the WarmTouch Product Line

• Determined the blanket performance by characterizing the warming blankets temperature zones using a FLIR thermo-camera.

• Nozzle Bottom failure; solved problem with an additional injection molded component to secure it in the Nozzle housing.

• Investigated customer complaints for the warming blanket not staying connected to the nozzle; improved the nozzle design; increased the nozzle’s ability to hold a warming blanket by 134%. All design changes were documented to be compliant with ISO 13485:2003.

• Worked with our Tech Pubs Dept. to insure the WarmTouch Model 5300 Blower Operations Manual was up to date to reflect all the changes and upgrades before its’ release.

Successful Product Introductions:

• DOC-10 Oximeter cable extension

• OEM-10 Oximeter cable extension

• WarmTouch® Model 5300, 5900 blower system up-grades

BECTON DICKINSON Inc. San Jose, CA 1996-2000

Mechanical Engineer II: BD Bio-Sciences R&D

Managed a technician for the mechanical prototype lab for the BD Bio-Sciences R&D Team, and contributed to the sustaining improvements in the fluidics system, laser beam delivery system, for FACSVantage SETM.

Major Accomplishments:

• Introduced CNC machining technology using Pro-Engineer (CAD), and Pro-Manufacturing (CAM) for rapid prototype part fabrication

• Redesigned the FSC mirror assembly that eliminated the thickness of the mirror as an assembly variable

• Designed a universal microscope slide holder for index sorting

• Improved the HV plates for high speed sorting

• Designed all the mechanical parts for the AccuDropTM system that reduced sort set-up time from 1-hour to 3-minutes per field service engineers

• Redesigned the High Voltage (HV) plates for high speed cell sorting

Successful Product Introductions:

• All the above improvements were incorporated into the FACSVantage SE-launched March 1999

SYSTEMIX Inc. Palo Alto, CA 1992-1996

Manufacturing Engineer /Mechanical Design Engineer

Established and managed an associate engineer for the Systemix High Speed Cell Sorter (HSCS) Mechanical Manufacturing Facility.

Major Accomplishments:

• Designed an Isolation Chamber to allow the HSCS to operate in a sterile environment

• Redesigned the Optical/Laser Beam Delivery System for the HSCS

• Successfully installed four High Speed Cell Sorters; two in Palo Alto, CA. and two in Lyon, France

EDUCATION

Bachelor of Science, Industrial Technology, California State University, Chico, CA.

Minor, Business Administration, California State University, Chico, CA.

AS, Electronics Technician Diploma, DeVRY Institute of Technology, Phoenix, AZ.

PATENTS

• Patent 5,641,457: Sterile Flow Cytometer and Sorter with Mechanical Isolation between Flow

Chamber and Sterile Enclosure and Methods for using the same

• Patent 5,776,781: Sterile Flow Cytometer and Sorter with Mechanical Isolation between Flow

Chamber and Sterile Enclosure

• Patent 7,172,616: Inflatable Blanket for use in Cardiac Surgery

• Patent 7,879,078: Use of Convective Air Warming System for patient care

• Patent 7,901,443: Method and Apparatus for Inflating a Warming Blanket

• Patent 7,905,911: Method and Apparatus for Connecting a Hose to a Warming Blanket

• Patent 7,951,184: Inflatable Blanket for use in Cardiac Surgery

• Patent Filed Tracheostomy Tube and Technique for using the same

• Patent Filed Sensor with Integrated Living Hinge and Torsion Spring

Continuing Engineering & Education

• Anesthesia Course for Engineers & Marketing Personnel Shands Hospital, Oct 2000.

• SolidWorks Advanced Surfacing Training, Dec 2006

• ISO 9001:2000 Design Control; May 2007. ISO 13485:2003: Medical Devices, Assessor Transition Workshop, Oct 2007

• SolidWorks Expo San Diego, Feb 2012

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