Process Development Engineer

Peninsula, CA

Posted: 09/17/2018 Employment Type: Direct Hire Industry: Medical Device Job Number: JOS000008019

PRIMARY DUTIES & RESPONSIBILITIES (other duties may be assigned as needed):

  • Establish design transfer requirements and timelines

  • Perform in-depth process development / statistical analysis

  • Independently design experiments, develop protocols, perform process validations and data analysis, draw conclusions and communicate results

  • Design & selection of equipment for manufacturing processes

  • Establish process flow and production line layouts

  • Act as the Operations representative on cross-functional product development teams

  • Train assemblers, technicians, and engineers on new processes

  • Present technical reviews of projects to cross-function teams

  • Occasional travel, as needed, to work with equipment and component suppliers

QUALIFICATIONS:

  • Ability to work in a team environment - strong in communication and negotiation skills.

  • Familiarity with medical device design control requirements

  • Hands-on individual with demonstrated process development experience

  • Ability to develop and maintain project plans

  • Attention to detail in process characterization and documentation

  • Ability to design and execute experiments to characterize and improve processes

  • Ability to develop and execute process validations

  • Ability to use Solidworks to model/modify components and assemblies

  • Experience boiling down high level (e.g. device level) performance issues into specific action items.

EDUCATION and/or EXPERIENCE:

  • Bachelor’s degree in Mechanical, Materials, Manufacturing or related engineering field

  • Minimum of 5 years of experience in a medical device manufacturing environment

  • Experience preferred with any/all of the following software: MS-Office, MS-Project, Rhino, Grasshopper, Python, GeoMagic Control, LabView, MatLab, 3DManage, Solumina, QAD, Omnify

 

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