Manufacturing Engineer - Development in West Menlo Park, CA at Volt

Date Posted: 10/23/2018

Job Snapshot

Job Description

Job Title:             Senior Manufacturing Engineer, Development        

Department:         New Product Introduction

Reports To:          Director of Manufacturing Engineering

FLSA Status:       Exempt

Prepared By:        Torsten Kimura

Date:                   08/24/18       

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Employee Name (Print)

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SUMMARY:

Sr. Manufacturing Development Engineer represents the Operations department from early design stages to product commercialization. Individual will be a key member of cross-functional product development teams, performing activities associated with process development and design transfer. The individual will be responsible for presenting technical updates to Sr. Staff, supporting the development team in areas such as Design for Manufacturability, process control/characterization, manufacturing documentation, and providing production support during engineering builds. Additionally, the individual will serve as a technical interface with key suppliers.



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

  • Establish design transfer plan, including requirements and timelines
  • Perform in-depth process development / statistical analysis
  • Design experiments, develop protocols, perform process validations and data analysis, draw conclusions and communicate results
  • Design & select equipment for manufacturing processes
  • Establish process flow and production line layouts
  • Present technical reviews to cross-function teams and Sr. Staff
  • Act as the Operations representative on cross-functional product development teams
  • Train assemblers, technicians, and engineers on new processes
  • 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 FDA and ISO medical device quality system 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
  • Familiarity with using Solidworks to modify drawings 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 desired with any/all of the following software:  MS-Project, Omnify, Visio, Minitab.

Please note that this position may have exposure to blood borne pathogens. Earlens will comply with Cal-OSHA requirements and will provide vaccination, communication, and training of its Exposure Control Plan.