Mechanical Design Engineer

3 weeks ago

Pleasanton, United States Rangam Full time

Onsite - Pleasanton, CA


This will involve transferring the documentation into the PLM (Arena) and PDM (Windchill) systems as well as new product design.

  • High School / GED is required.
  • Pulling data from agile and putting in to arena
  • Training in solidworks
  • Must be have experience with PLM software (Arena, Agile).
  • Must be highly proficient with SolidWorks.
  • PDM software exp needed
  • Move files from solidworks to windchill
  • working in system to release documents
  • update files
  • Create items in Arena to document specifications, BOM, sourcing, documentation, compliance status.
  • Windchill is a plus
  • Prefer at least three years of experience in medical devices.
  • Must have experience with Windchill or similar PDM software.
  • Technical education preferred
  • No agile exp needed
  • Masters degree will be considered
  • No coding or programming exp needed

Purpose:

  • Support the R&D team as a CAD Designer/Drafter for the Mechanical Team, in preparing CAD drawings and administering the CAD portion of projects.
  • This will involve transferring the documentation into the PLM (Arena) and PDM (Windchill) systems as well as new product design.

Responsibilities:

  • Create items in Arena to document specifications, BOM, sourcing, documentation, compliance status.
  • Create and maintain/update drawings using SolidWorks.
  • Document ECO changes within R&D Document Control.
  • Manage the simultaneous development of several parts and subassemblies for a project design.
  • Track bills of material status during prototype development.
  • Works in an independent manner under the guidance of a supervisor or technical lead. Assignments have clear and specified objectives
  • Complies with applicable policies and procedures, regulatory and safety requirements.

Qualifications:

  • Must be authorized to work in the US on a permanent basis
  • Post secondary technical education (AA or other equivalent training).
  • Must have at least five years of product design and development experience.
  • Prefer at least three years of experience in medical devices.
  • Must be highly proficient with SolidWorks. Must have experience with Windchill or similar PDM software.
  • Must be have experience with PLM software (Arena, Agile).
  • Must be familiar with the capabilities and limitations of a variety of fabrication techniques and the proper documentation of parts made using those techniques (e.g. plastic injection molding, vacuum and pressure forming, sheet metal stamping, machining).
  • Individual will complete work with minimal supervision of the manager or the project technical leader.
  • Ability to set short term project goals and outline schedules for design or test of multiple parts.
  • Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR),ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.High School / GED is required. Technical school completion / certification preferred.

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