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•             Be an important member of a cross functional team responsible to assess product design files, identify and resolve technical gaps in preparation for Regulatory submissions. You will be critical R&D engineer working closely with subject matter experts to investigate and verify technical information, generate justifications, execute testing protocols and write reports.



•             Create performance verification protocols and write reports.

•             Execute test protocols, summarize data, analyze and make conclusions.

•             Investigate design history files, design specifications, test reports and manufacturing documentation to provide accurate and timely technical information for Regulatory submissions.

•             Work closely with subject matter experts to development technical justification reports.

•             Prepare product drawings and illustrations for Regulatory submission. 

•             Attend appropriate meetings – technical and core team, providing updates as required.



•             Ability to read, analyze, interpret, create, and meet: product specifications, technical procedures, and worldwide governmental regulations.

•             Ability to develop test protocols, execute testing, statistically analyze data, and develop conclusions. 

•             Ability to write technical reports and justifications. 

•             Excellent interpersonal skills, works well within a team, able to collaborate with and influence others.

•             Excellent oral and written communication skills.



•             Bachelors in Engineering required.  BS in Mechanical or Materials Engineering preferred.

•             3-4 years engineering experience in medical device product development and/or manufacturing environment preferred. 

•             Experience with mechanical characterization methods such as tensile, compression or modulus testing preferred.

•             FDA Quality System Regulation Part 820 and ISO 13485 experience preferred.

•             Working knowledge of SolidWorks CAD software is preferred.


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