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Manufacturing Engineer

  • Job type: Contract
  • Location: Hayward, California
  • Salary: Competitive
  • Job reference: 209661/002_1536873367
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 13/09/2018

A medical device start-up in Hayward is looking for a Manufacturing Engineer to join the team to assist with production ramp up. The role will be reporting to the director of manufacturing to support production and manufacturing. The ideal candidate will provide guidance for manufacturing of the company's product line, from initial concept stage design, through verification, production and into initial clinical evaluation and commercialization. Products manufactured are done so in accordance with the Quality Management System and company's objectives and timelines. Additionally, the Manufacturing Engineer will work with distribution partners and third party manufacturing firms to produce product.

Job Requirements:

  • Bachelors in Engineering or other related science degree

  • 5+ years engineering within a regulated industry, strong preference towards medical device

  • Experience in an FDA and ISO regulated environment

  • Experience with electro-mechanical assemblies

Job Scope:

  • Apply engineering knowledge to the manufacturing of new products as well as process changes

  • Lead technicians and assembly staff

  • Work cross functionally with Quality, R&D and operations

  • Authors and implements process validation activities.

  • Contribute to product design of medical device and maintain DMR.

  • Worth with contract manufacturers and suppliers to ensure proper manufacturing

  • Provide on-going technical support to production line for equipment, process or design related issues.

  • Implements changes to continuously improve manufacturing systems in terms of quality, cost, cycle time, and capacity.

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