Six Sigma Engineering
Resume:
Resume
Author: Jairo ******---****@*********.***
Job: Process Engineer II
Company: DinaliC LLC.
Location: US-FL- Miami, Florida.
Seventeen years of biomedical instrument engineering experience.
Fourteen Seventeen years of data communication engineering experience.
Practices, applies sound and realistic methods of scientific applications,
and good quality principles, in process control, design, and in the testing
of product. Excellent work ethic, able to multi task and prioritize. Vast
experience with instrument validation, qualification testing, the in the
product developing phase stage, product testing, tracking and reporting of
Clinical Diagnostic, Hematology, Flow Cytometry and OEM instruments prior
to shipment, qualified components and performed the testing and
temperature qualification of reagents, Experienced in the execution of
root cause analysis of nonconformance materials, and has performed Failure
Mode Analysis on sub-assemblies, field return, has written procedures for
the analysis and testing of all sorts of materials, such as plastics,
metals, components, reagents, and other surfaces., Instrumental in the
implementation and execution of Lean-Six Sigma practices and procedures.
Responsible for updating and pointing out discrepancies on reports of
statistical data,
Core Competencies:
. Team Player and Leader.
. Validates, and qualifies medical instruments.
. Verifies processes.
. Implements Lean Six-Sigma methodologies(Kaizen Event, Value Stream
mapping(VSM)
. FDA / cGMP / ISO, ISO, OHSAS compliances, and clean room entry
requirements.
. Failure Mode And Effects Analysis (FMEA)
. Writes test protocols, test procedures, and final test reports.
. Six Sigma, Kepner-Tregoe.
. Analytical and scientific skills.
. Reliability and fault analysis.
. Root Cause Analysis.
. Product Developing Process.
. Material compatibility analysis and testing.
. Managerial and supervisory skills.
. Quality project management skills.
. Procurement and contract lease.
. Analog and digital.
. Good oral and written communication skills.
. Reengineering Processes.
. Computer proficient, Microsoft Office Suite, MS Project, Power Point,
Access
. Bilingual
. Veteran
BECKMAN COULTER, INC., Miami, FL, 10/1991 02/2008-17 Years
Principal Engineering Technician.
. Performed verification, validation, and qualification on medical
instruments, and on biomedical devices.
. Improved yield and reduce failures and waste by 15%, with the
implementation of the Lean-Six Sigma (Kaizen Event), and with Value
Stream mapping(VSM)
. Made major contributions and timely inputs for the implementation and
subsequently the approval of CGMP \, FDA'S compliance of 21 CFR Part
11, in a medical regulated industry.
. Lead a team in charge of enforcing, and implementing laboratory safety
and compliance to environmental control procedures of FDA, ISO, and QS
regulations.
. Assisted in determining methods or actions to remedy malfunctions.
. Responsible for performing Failure Mode and Effects Analysis on non-
conforming material, and parts, this included reagents and components.
. Performed test estimates to be used for measuring reproducibility, and
repeatability of product developing
. Perform preventive and corrective maintenance on biomedical
instruments, required
. Performed operational tests and fault isolation on biomedical systems
and equipment.
. Performed biomedical safety inspections in laboratory, and corrected
action items.
. Instrumental in the solving, and training for FDA, ISO and CAPA action
items,
. In charge of the safety laboratory inspections, and their FDA
compliance.
. Analyzed needs, then determined resources needed in order to achieve
manufacturing goals according to product specifications.
. Increase the testing capabilities of the group by 10%, by identifying
needs, researching and procuring new equipment to meet organizational
demands and balance the sizeable workload.
. Successfully reduced expenses by 25% through skillful budget
management and cost containment.
. Main contributor, and assisted in reagent environment temperature
qualifications.
. Performed instrument qualification, and validation, while working with
the product developing department.
. Wrote and develop test instrument protocols, test procedures, to be
used for product developing, and product testing.
. Responsible for developing specifications for the purpose of product
testing.
. Responsible for designing, testing, analyzing and constructing
electrical, pneumatic and mechanical assemblies circuits, in a
biomedical environment.
. Responsible for the developing and interpreting schematic diagrams,
engineering sketches, and assembly drawings for the purpose of
constructing breadboards, prototype biomedical devices, and production
hardware.
. In charge of performing calibration, and functional checks on
electronic medical instruments.
. Provides floor support, and gets involved in every phase of the
project.
. Writes protocols, qualification, validation, engineering, and final
reports.
. Analyzed needs, then determined resources needed in order to achieve
manufacturing goals according to product specifications.
RACAL MILGO, INC., Sunrise Boulevard, FL, 06/1977 9/1991, 14
years
Senior Technician, with the engineering group
. Performed testing of new engineering modifications models and help in the
design of the testing aids, such as software, automatic test stations,
test fixtures.
. Design, put together and tested test stations.
. Trained other tests on the latest test requirements, and test procedures
. Recorder and archived all instrument test data
. Performed R & D experiments, such as the testing of new components, and
testing devices.
. Maintained and repair all automatic and semi-automatic test equipment.
. Performed root cause analysis on non-conformance materials, and on field
return units.
. Responsible for the implementation and training of the TQM and JIT
processes within the group.
. Processed contract deals for new, refurbished and OEM instruments.
. Worked out purchasing agreements to replace data communication equipment
being updated for instruments been phase out.
. Researched, justified and purchase testing equipment.
. Responsible for all procurement activities, this impacts the support of
all the testing and qualification.
EDUCATION, TRAINING AND TECHNICAL SKILLS
Bachelor of Science (BS) in Business Administration, Dec 2006
Associate of Science (AS) in Information Technology, 2004
Associate of Science (AS) in Electronics Technology, 2001
Computer Proficiency
Proficient in all Microsoft Office Suite applications, Word, Excel, MS
Project, Access,
Networking (LAN/WAN, mainframe systems) Weibull (Reliability analysis
tools)
References upon Request
Contact this candidate