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Posted by: CCSI Inc - Robert Ryder <robert@ccsiinc.com> on August 13, 2009 at 14:28:19. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Temp to Perm
City: Northridge
State: California
Country: United States

Design history file review to collect, review, and update as necessary, risk assessment and Design FMEA documentation on existing market released devices, Diagnostic and therapeutic medical devices and device programmers., Assure the timely, accurate and independent evaluation of product performance and safety prior to clinical studies or market release. ,May provide leadership to others., Prepare, review and approve Qualification Test Plans and Reports for assigned projects., Provide technical support for technicians performing the testing., Assure the resolution of all issues raised by the testing., Take on special projects in which only the results are specified and complete them on schedule. This may involve making presentations/recommendations to management.

Candidates will be working on NGP. Medical Standards Highly Preferred. Other regulated experience considered. 5+ years of experience required. Undergrad degree in Science/Engineering a must. Graduate degree a plus. OT will be required for this role. Candidate must have great communication skills, be able to think outside of the box to solve complex problems interfering with the objective, and work in a cross-functional team. Title: Sr Design Assurance Engineer/Quality Engineer. This person will have the sole responsbility for hte creation, documentation, and execution of reliability test protocols to assure the design life of new products. This may include HALT, HASS, AGREE, ORT and/or Reliability Growth Tests and fixture design/development. Testing may either be in-house or contracted depending on resource availability. Strong background in accelerated life testing required. Candidates must be able to instill confidence in others. Experienced and pragmatic. Demonstrated capability to improve product reliability.