Education:
Bachelors Degree ( 16 years)
Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)
An equivalent combination of education and work experience
Masters Degree ( 18 years)
Ideal
Experience:
Minimum 4 years
Relevant experience
Solid knowledge of general Engineering principals.
Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.
Experience in all of the following: performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.
Writing process/product requirements and design specifications.
Working on a development team with an emphasis on minimizing time to market.
Design for manufacture of low cost, high volume electronic products.
Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
Cross functional team environments is required.
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