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High School Medical Devices

Location:
Hayward, CA
Salary:
$27
Posted:
November 21, 2023

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Resume:

OBJECTIVE: To obtain a position where I can utilize my work experience and education to improve the company’s operation.

EDUCATION

San Jose High School, San Jose, CA

De Anza College/ Fremont Adult Education- Basic skills and medical training classes

SUMMARY OF SKILLS

Bilingual in Spanish, reading, writing, and speaking capabilities

Strong leadership capabilities and effective communication with team members

CAREER HIGHLIGHTS/QUALIFICATIONS

Solid electronic mechanic assembler

Highly adapted to varying environments

Strong attendance record, always punctual.

Worked effectively in a fast paced environment.

Met demanding deadlines and worked overtime as requested

Highly reliable, flexible, and focused on high quality standards

Strong Problem solving and root cause-trouble shooting ability

Consistently met timelines and standards to complete job objectives

PROFESSIONAL EXPERIENCE

Pacira Pharmaceuticals, Inc 10/2016 - Present

Sr. Manufacturing / Production Assembler

Assists manufacturing team in developing the manufacturing process instructions (MPI)

Responsible in subassemblies and system assemblies for medical device

Supports all assembly/manufacturing related issues including diagnostic, product rework and repair.

Assist for training the new operators and assemblers in device assembly process and testing.

Follow FDA regulations, Good Manufacturing Practices (GMP), general safety and manufacturing procedures, company practices and policies.

Cormatrix, (Manufacturing) Operation Associate April 2012 – December 2015

Responsible for the performance of manufacturing processes, operation of production equipment and in-process inspection of product.

Reporting to the Director of Operations and Quality Systems

Responsible for performance of manufacturing operations including packaging of medical devices, visual inspection and assistance with shipping and administrative activities in a small company environment.

Responsible for executing tasks with minimal supervision and maintaining a high level of accountability for work performed.

Performs product packaging of clinical and commercial products.

Operates production equipment, including but not limited to label printing equipment.

Performs in-process and visual inspections to assure product meets specifications.

Assists with shipping including checking customer orders and packaging for shipment.

Light computer work, filing, scanning.

Ensures that work output and quality meets established standards.

Documents work performed and maintains accurate records to comply with

the FDA Quality System Regulation, ISO 13485:2003 and internal Standard

Operating Procedures.

Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity’s relating to products, processes, and the quality

Cardiva Medical Assembler, October 2008 –April 2009

Assembled detail assemblies of small parts under a microscope

Performed inspection, and testing of small medical devices.

Followed MPI (Manufacturing Process Instructions.)

Packaging use of labeling and strapping for shipping.

Documented work after inspection accordingly.

Open and close manufacturing orders. Documents work performed and maintains accurate records to comply with the FDA Quality System Regulation, and internal Standard Operating Procedures.

Assigned and perform Re-work instructions.

Assembled various medical devices such as Vascular Closure System, single device to offer collagen and a dual mechanism of action; physiological and mechanical completely. It is a fully integrated, completely bio-absorbable, easy to use vascular closure system.

Xtent, INC., Manufacturing Sub-Assembly II 2006-2007

Packaged medical products for shipping.

Following instructions on MPI, LHR for quantity.

Verifying parts numbers and lot numbers from MPI.

Packaging and boxing, and shipping and receiving labeling, pouching, peel test, using sealer machine, trimming washing parts for R&D.

Working with manufacturing R&D engineering stet stop, sealed the balloon to close the cathedral. Fabricate flushers, pushers coding, style slider section under a microscope using multiple handle attachment.

Assemble medical devices in clean room environment.

Abbot Vascular, Inc., Manufacturing Assembler 2005-2006

Assemble medical devices in clean room such as: vascular closure 9, P8, P10, catheters, stents, etc.

Accessories assembly such as: Suture Trimmer, Clincher, Knot Pusher, etc.

Assemble small, intricate parts using a variety of instruments and fixtures.

Working in molding department as well.

Worked cross functionally with R&D and Engineering.



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