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Mechanical Engineer

Orange County Metro Area, CA

Post Date: 06/04/2018 Job ID: JN -062018-21755 Job Type: Scientific
Description:
Sr. Mechanical engineer who will design and develop a consumable medical device used on the vitreoretinal surgery. As a part of the R&D team, one will perform one or more of the following tasks:
  • Be technical lead for new consumable development and ensure that design activities are coordinated for SOP and GMP.
  • Responsible for leading, participating in or supporting the product development activities such as prototyping/testing, pilot builds, verification & validation testing, risk assessment and production tooling validation.
Responsible for project planning and provide technical leadership in project execution

Skills:
The following qualifications are required:
  • Adequate skillset with 3-D CAD (Solid Works or Pro-E)
  • Equip with a high degree of engineering problem solving skills.
  • Knowledge pneumatic design concept
  • Able to design complex assembly tool/fixture to support high volume production.
  • Knowledge in a high volume manufacturing process (laser welding, press-fit, crimping)
  • Excellent teamwork skills with ability to lead.
  • Knowledge in plastic injection molding and over-molding.
  • Experience with rapid prototype design and build for proof of concept.
  • Experience with selection of bio-compatible material.
Familiar with Medical Device Directive, FDA and other similar regulatory directive.
BS in mechanical or bio-mechanical

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