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Engineer II

Orange County Metro Area, CA

Posted: 11/29/2018 Job Type: Engineering Job Number: JN -112018-23146
Engineer II
Lifesciences Industry
Irvine, CA
Duties:
  • Support NPI team and participate in cross functional initiatives relating to NEW product design / development, validation activities, process qualification and transfer activities
  • Support in drafting and execution of Transfers & Qualification Strategies, Master Validation Policies / Planning, Product / Process Validation Plan, Quality / Process Control Plan, Design / Process Failure Mode and Effect Analysis (FMEA) and Tools / Fixtures Installation Qualification (TFIQ)
  • Lead in setup of Bill of Material (BOM) and routings, product drawings and revise assembly procedures as necessary in support of product design / production process transfers
  • Lead in drafting and revising of product and process assembly procedures to enhance/clarify of contents
  • Support packaging engineering validation efforts in support of product design / production process transfers and valve engineering projects
  • Lead Manufacturing builds (feasibility, qualifications, commercialization) in cleanroom and be able to train and resolve manufacturing issues on the floor with sustaining engineers.

Education:

Bachelor s degree in a technical discipline such as mechanical, industrial, chemical engineering required

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