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Materials Engineer

Company:
LanceSoft Inc.
Location:
Minneapolis, Minnesota, United States
Posted:
June 10, 2019

Description:

POSITION RESPONSIBILITIES:

• Provide technical support to regulatory submissions in the area of biocompatibility and Hazardous Substances.

• Provide assessments of existing and new medical device product against current medical device regulations and international standards.

• Determine activities needed to remediate medical device product biocompatibility and hazardous substance data to current requirements.

• Document compliance of product to internal procedures.

• Support the quality and reliability of released product through comparative testing or root cause characterization testing.

• Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

REQUIRED KNOWLEDGE:

• Knowledge of materials and interactions with the body and environment

• Ability to correlate material properties with product performance and predict various failure modes

• Knowledge of international and domestic regulations associated with biocompatibility and Hazardous Substances

• Experience in a regulated industry

• Knowledge of Microsoft applications (Excel, Word, Outlook)

• Materials Science knowledge with an emphasis on materials testing, processing and analysis

• Demonstrated problem solving and critical thinking skills