HI All,

We have the below open position please have a look and let me know your
interest.

*Job Title: Manufacturing Engineer with medical device background*

*Location: Pleasanton, CA and Plymouth, MN and Sylmar, CA*

*Duration: Long Term Contract*


*Job Description:*

   - Should possess 02- 03 years of Change management experience
   - Manage projects which include new production equipment, process
   improvements and cost reductions while supporting new product
   introductions. Provide guidance to other engineers and technicians.
   - Perform projects which include new production equipment installation
   and qualification, process improvements, yield improvements, and cost
   reductions while supporting daily production activities.
   - Collect and analyze in process data to evaluate capability and
   determine areas for process improvement.
   - Drive process improvements and validations through manufacturing
   implementation and update pFMEAs and master validation plan as required.
   Author process validation protocols and reports. Including but not limited
   to equipment IQ, process OQ, process PQ, and product PPQ.
   - Provide direct technical support on production issues (e.g. part &
   assembled product quality dispositions, interim containment actions, root
   cause analysis, resolution planning, validation, & implementation) under
   NCMR or CAPA. Provide guidance to other engineers and technicians.
   - Coordinate the design, procurement, build and debug of tooling,
   machinery and test equipment
   - Improve product quality, labor efficiency, and throughput through the
   use of Lean manufacturing concepts like Value Stream mapping, 5S and Visual
   Workplace.
   - Work with cross-functional teams to transfer new products efficiently
   and effectively into manufacturing.
   - Work with various internal and external organizations to optimize
   manufacturing processes or resolving technical issues w/ on-going products
   or new products.
   - Provide technical support to manufacturing and QA to improve
   productivity and reduce costs.
   - Participate as a manufacturing lead and/or support a lead on
   cross-functional core teams.
   - Performs other related duties and responsibilities, on occasion, as
   assigned.


*Individual should:*

   - Be innovative, resourceful, and work with minimal direction
   - Have excellent organization, problem solving, communication, and team
   leadership skills
   - Work effectively with cross-functional teams


*Preferred:*

   - Medical device experience strongly preferred, International
   manufacturing experience preferred. Knowledge of ISO and/or FDA quality
   system regulations as it pertains to design transfer and process control
   preferred.
   - 4 + years’ experience in Manufacturing involving handling multiple
   projects, strategically prioritize activities across functional teams
   within Operations/Manufacturing
   - BS or MS in Mechanical Engineering preferred




Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

E:  saikiran.nandr...@w3global.com

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