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Sr. Mechanical Engineer

Orange County Metro Area, CA

Posted: 08/15/2019 Job Type: Engineering Job Number: JN -082019-25443

Sr. Mechanical Engineer

Biotech Industry

Lake Forest, 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


Skills:


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.


Education:


Bachelor s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+2 yrs)

The ability to fluently read, write, understand and communicate in English

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