Product Development Engineer (Medical Devices) Minneapolis, MN Please Reference Job ID: 300306-7258-13-300439 Product Development Engineer (Medical Devices) Provide support to product development teams by creating solid, repeatable, and clinically relevant methods with which to evaluate the design. The position requires an understanding of how the product performance and the test process used to insure requirements are met from conception through production release. Candidates will assist the engineering team in driving test methodology improvements including, but not limited to, team meeting participation, test development work, assisting in specification generation, and performing experimental lab work. Essential Functions: Design and develop test methods (including relevant models/fixtures) for the evaluation of new interventional medical devices Generate the necessary documentation including the method itself, fixture drawings, and Measurement System Analysis (MSA) protocols/reports Design, execute, analyze, and summarize results of characterization testing Work with design engineers to identify key product characteristics to be evaluated Development and justification of clinically applicable test methods Conceive and build prototypes Work with outside consultants, vendors, and the medical community Project planning Support animal and bench testing and clinical evaluations Plan, coordinate, and execute activities in support of project goals Establish requirements and specifications Ensure compliance with procedural and documentation requirements of SJM, FDA and ISO design controls Requirements: Bachelor's degree in engineering or related scientific discipline 3+ years of medical device experience Experience with both 510(k) and PMA medical device products Experience with development and execution of test methods Proficient in the use of lab and test system equipment and statistical theory required for data analysis Excellent written and verbal communication, record keeping and problem solving skills Solidworks experience preferred Analytical design, Design for Six Sigma, or similar tool set preferred Volt is an Equal Opportunity Employer