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Sr. Mechanical Engineer

Orange County Metro Area, CA

Posted: 06/10/2019 Job Type: Engineering Job Number: JN -062019-25059
Sr. Mechanical Engineer
Biotech Industry
Irvine, CA

  • 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
  • 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.
  • Minimum of 10 yrs of engineering with 5 yrs experience in medical device design
  • BS in mechanical or bio-mechanical
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