Medical Device Technician

JOSEFINA (CHARITO) VENTURA

Santa Clara, CA *****

Email: **********@*********.***

Mobile Phone: 408-***-****

EXPERTISE

• 10+ years’ manufacturing experience in the field of Medical/Biotechnology company

• 6+ years’ Silicon Valley medical company production lead experience

• Improved processes and work procedures in support of Continuous Improvement Programs (CIPs)

• Collaborated closely with Managers, QC team, and Manufacturing Engineers to identify and resolve test failure issues

• Experienced in production inventory, scheduling, and data entry of daily production output and yield

• Experienced in assembly of medical device under microscope using hand tools, Blue print reading, Testing, Hot Box, Vertical shrinker

• Actively participated in FDA, KEMA, and internal audits

• Experienced working in GMP and FDA regulated environment

• Well-versed in ISO 9001 certifications

• Proficient in MS Office programs –Excel, Word, capabilities

• Final visual inspection of finished devices

• DHR review for accuracy and completeness

• Proven track record in motivating and leading teams to peak performance

KEY ACCOMPLISHMENTS:

• Promoted within three months to Lead position from Test Technician

• Improved device test yield to 96% from 84%

• Saved failed devices from going to scrap by spearheading and implementing rework procedures

EMPLOYMENT

Epicor/St Jude Medical – Sunnyvale, CA December 2004 to July 2011

Manufacturing Lead April 2005 to July 2011

Manufacturing Technician December 2004 to March 2005

Responsibilities:

• Supervised day-to-day Final testing of High Intensity Focused Ultrasound (HIFU) medical device for the treatment of Atrial Fibrillation (AF)

• Assisted QC department with visual inspection of finished devices

• Reviewed daily production traveler, test reports of all test technician for accuracy and completeness before passing to QA department

• Facilitated root cause analysis investigations in regard to test failures

• Continuously looked for areas of improvement within existing processes and communicated ideas with the engineers and management accordingly

• Performed daily hand cycle count and reporting of inventory to ensure accurate inventory

• Facilitated entry of daily production output and yield

• Assisted Test and Manufacturing Engineers in revision of test protocols

• Supported Manufacturing Engineers to resolve problems and to test Engineering Work Orders (EWO) and new test procedures

• Ensured that test technicians are always compliant with GMP guidelines and strictly followed MPI

• Trained newly hired technicians according to approved protocols

• Performed final testing of finished devices

Symbio Corporation – Menlo Park, CA November 2004 – October 2007

Laboratory Technician (Part Time)

Responsibilities:

• Performed quality control testing on chemistry consumables

• Experienced in using multi-channel pipettes, buffer dispensing machines, and autoclaves

• Prepared buffer solutions, consumable plates, and tubes for laboratory testing

• Tested 96 well and 384 well DNA samples using Megabace sequencing instrument

• Maintained laboratory equipment and monitored laboratory supplies

• Maintained detailed laboratory notebook

Amersham Biosciences – Sunnyvale, CA February 2001 – August 2004

Laboratory Technician

Responsibilities:

• Performed QC testing on chemistry consumables

• Inspected 96 and 384 capillary arrays from local and international clients

• Furnished MRB and Inventory reports

• Prepared consumable plates and tubes for laboratory testing

• Assisted the research and development department

• Tested Megabace DNA sequencing instrument

• Worked in cGMP environment

• Final assembly of Megabace DNA sequencing instruments

EDUCATION

BS Business Administration, University of the East Manila, Philippines

QC/QA Training Program, San Jose City College San Jose, CA

AWARDS, CERTIFICATES, AND TRAINING

• Outstanding performance and contributions in yield and quality improvements

• Outstanding performance and contributions in the production layout

• Certified in Hazardous waste management

• Trained and certified in KAIZEN Lean Manufacturing

REFERENCES

Tony Pinon, Production Manager – 408-***-****

James Due Production Supervisor- 650-***-****

Igor Stroev, Manufacturing Engineer – 408-***-****

Marsha Stanowski, Document Control Specialist – 408-***-****

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