Cordis Corporation - R&D Resume Example

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Claire Diaz
XXXX XXX XXXX XXXXXXX XXX XXXX, Fremont, CA 94538 | (H) XXXXXXXXXXXX | XXXXXXXXXXXXXXXXXXXXX
Summary
Medical device product development leadership (from concept to
market) and manufacturing process transfer with over 10 years of experience in:
510(k), CE Marked and PMA Devices
Experienced in Medical Device design and development
Strong cross functioning team work – R&D, QA, Operations,
Regulatory and Clinical
SOP Development and GMP Compliance
Support with regulatory (FDA, BSI, PMDA) submissions
Manufacturing process transfers
Black Belt trained (ASQ and JnJ)
Test
Method Validation (TMV)
Equipment
Validation (IQ/OQ),
KAIZEN
activities
Design
and Process Characterization and validation (DV&V, OQ and PQ)
Design
for manufacturing

Skills
  • Black Belt Trained (ASQ & JnJ)
  • Product Development life cycle 
  • Medical Device Manufacturing and Processing
  • Complex Problem Solving
  • Critical Thinking
  • Time Management
  • Results and performance driven
  • Leadership and planning
  • Strong communication skills
  • Foreign Language (100% Spanish)
Experience
R&D/Process Engineer 01/2013 to Present
Cordis Corporation Fremont, CA
FOD/R&D Engineer responsible of product and process design, characterization and validation activities such as DV&V and IQ/OQ/PQ for best in class 0.018” PTA balloon catheters (Saber OTW and Saber RX).
Responsible for the process validation strategy for a next generation Guiding Catheter (Adroit 6F/5F) and CTO product iteration (Outback Elite).
Leading engineer for manufacturing process characterization (i.e balloon bonding) and manufacturing line transfer between R&D site Fremont, CA and manufacturing site Cd. Juarez, Mexico.
Development and execution of project validation strategies. Support on planning and executing design verification and validation activities. Responsible for production readiness for new product introductions. 
FOD/Process Engineer 07/2006 to 01/2013
BEPC, INC EL Paso , TX
Process development for next generation 0.035” PTA balloon catheter (Powerflex Pro) responsible for manufacturing line transfer and process validation strategy (IQ/OQ/PQ). Support for DV&V activities and regulatory submission.  
Responsible for process characterization and validation activities of a new vascular closure device (Exoseal). Transfer the manufacturing line from California to Cordis (Mexico).  Development of product and process specifications for the Exoseal project. Support on external supplier qualifications activities coordinating efforts with outside suppliers to qualify new raw material components.  
Supported Cordis San German, Puerto Rico and Cordis Juarez, Mexico in a UBD increase program for product Cypher performing packaging equipment validation activities such as IQ/OQ/PQ and designing specifications and coordinating manufacturing personnel.  
CAPA projects for Cordis (Mexico) supporting activities of component validations and supplier qualifications. This includes coordinating efforts with outside suppliers to qualify new raw material components. pTA1�p9*v
Packaging Engineer 07/2005 to 07/2006
Cordis de Mexico Cd. Juarez, MX
Support validation activities for new and existing products creating and modifying internal documents (Product and process Specifications, Manufacturing SOPs, Receiving Inspection Reports) to be in compliance with Cordis procedures. Perform packaging supplier qualification activities for project transfers. Packaging equipment validation (IQ/OQ).
Process Engineer 01/2005 to 07/2005
LEAR Furukawa Cd. Juarez, MX
Responsible for a green belt six sigma project to improve company's productivity by reducing the manufacturing process takt time, implementing a one-piece flow approach and maximizing line capacity generating savings of $180,000.00.
Education
MBA: Business Dec 2012 ITESM - Cd. Juarez, MX
Bachelor of Science: Industrial Engineering Dec 2006 ITESM - Cd. Juarez, MX
Languages
English, Spanish

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About this resume

R&D FROM Fremont , California RESUME

This is a resume for a R&D in Fremont, California with experience working for such companies as Cordis Corporation and BEPC. The grade for this resume is 0 and is one of hundreds of R&D resumes available on our site for free. Use these resumes as templates to get help creating the best R&D resume.

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School Attended
ITESM