Job Description Summary # Job Description Primary focus of this position is to perform engineering gap assessments using various analysis means, recommend design or tool changes, update models and drawings and conduct verification testing as necessary. The candidate will conduct these activities following BD Design Control procedures and practices. The candidate may write test protocols, perform hands-on testing and test reports. The candidate will present work in word or power point formats to management to collaborate on next step decision making and support other activities in the BD collaborative environment. Responsibilities: + Identify gaps in component designs to one or more ISO standards + Perform 3D and 2D comparative analyses as needed. + Work with Operations teams to understand current dimensional properties of components + Write test protocols as needed to determine functional performance + Conduct and/or oversee requisite metrology and testing (MSAs, Gage R&R) + Write test reports + Set-up test equipment and perform product tests as needed. + Conduct meetings to present findings, recommendations and obtain collaboration on next steps + Use DFSS methods to communicate test results and product confidence and reliability. + Facilitate building test parts for engineering evaluation and pre-clinical studies. Qualifications: + B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent. + 5 years of experience in R&D or product development with Bachelors degree or 3 years experience in R&D with Masters degree; preferably in medical device or other regulated FDA/QSR and ISO environment. + Must have plastic injection molding experience. + Experience in verification testing including writing protocols and reports to support verification activities. + Experience leading small projects and communication to management. Preferred Qualifications: + Experience with high volume disposable products. + Training in Six Sigma or Design for Six Sigma. Ability to analyze data, interpret results and write reports. Proficient in statistic software, such as MiniTab, is a plus. + Demonstrated problem solving skills and hands-on technical aptitude + Excellent oral and written communication skills + Knowledge of cGMP and GLP is a plus. Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-PRO EU MDR # Primary Work LocationUSA CA - San Diego TC Bldg C&D # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.