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R&D Engineer - (Instron)

Company:
LanceSoft INC
Location:
Franklin Lakes, New Jersey, 07417, United States
Posted:
December 05, 2016
Description:

Qualifications:

BS in Mechanical Engineering or Biomedical Engineering or closely related disciplines required OTHER REQUIREMENTS: • Technical writing experience required • Prior experience working in medical device field or regulated industry a plus • Experience as member of a project team tasked with resolving technical issues or continuous improvement projects • Capable of making practical assumptions with engineering justifications, where needed • Experience with collecting and recording data, interpreting data and writing technical reports in a manner consistent with QSR, ISO, and GMP guidelines • Experience with laboratory testing and equipment, such as Instrons • Experience in delivering on-time to an existing project plan • Ability to evaluate and summarize test results in written reports, including observations and discussion on findings and present results to team members orally and in writing • Experience with statistical analysis and methods within Minitab and Microsoft Excel • 3D CAD modeling using SolidWorks is preferred • Hands on-experience operating and programming of material test equipment • Self-initiator, results driven, and action- and detail-oriented • Experience with working in a product/design qualification/testing lab within R&D that supports development of medical device products • Demonstrated experience with all phases of the Design Control process in the context of FDA regulation and understanding of disciplined product development processes, regulatory and quality requirements for medical products • Excellent interpersonal, written and verbal communication, and influencing skills • Strong technical judgment and problem solving skills

Responsibilities:

As an R&D Engineer, the ideal candidate will write verification reports, test instructions and protocols. Therefore, the candidate must be capable of identifying and breaking down technical problems resulting in robust solutions. The candidate many perform test method evaluation/development/re-design, and design test fixtures. The ideal candidate will participate in executing technical and cross-functional project work in support of R&D activities.