Description
-Must have hands on new product development experience working closing with R&D-Utilize engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, SPC, software development).
-Experience in the medical device industry working on design controls is required
-Assesses reliability and risks based on data, identifies root causes of problems, and reduces or eliminates sources of variation
-Experience working with Balloons, stents, or catheters is a plus.
A minimum of a Bachelor's degree in a Science, Engineering or related technical discipline with a minimum of 6 years of experience, OR a Master's or advanced degree in a technical discipline with a minimum of 5 years of experience is required. Functional knowledge of/and experience in Quality Assurance in a Medical Device environment is required. It is preferred that this candidate have previous experience in R&D Quality.
Experience in the medical device industry working on design controls is required. Experience with a statistical package (Minitab or other) is required. Inspection plan design experience is an asset. Process Excellence training or certification is an asset. It is preferred that this candidate be Six Sigma/Lean certified.
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