ENGINEERING MANAGER Professional Summary Experienced product development Engineer manager able collaborate cross functional team well customers sales bring brand new offerings new markets. Skilled managing cross functional team continuous improvements meeting project deadlines. Offering 6 years experience field. Skills Microsoft Office Microsoft Project Product development Quality Research Six Sigma Green Belt Solid Works Visio Prioritization Personnel management Critical thinking skills Team management Analyst, Visio Agency Consulting Cost analysis Critical thinking Designing Dialysis Direction Develop drug Functional IIa ISO Leadership Market development Microsoft Office Microsoft Project Personnel management Design process Product development Product management Quality Researching Research Sales Six Sigma Solid Works Team management Validation Work History Engineering Manager 03/2018 Current City State Create maintain Technical Files per MDR requirements well attaining 510k legacy products. Assess testing gaps legacy products design creep. Experienced working multiple departments. Experienced training leading engineers order investigate field complaints, Gap analysis building Technical files/DHF. Experienced leading team engineers lead aspects design process, including regulatory needs per market development per design control. Tasked create test plan analysis existing Class I, II III products Testing per latest applicable requirements. Trained team conducting project related cost analysis, test gap analysis researching ISO/EN ISO/ASTM requirements. Leading companywide EU MDR product transfer testing Infusion products, Dialysis products standalone products. Provided technical direction MDR 510k related projects initiatives engineers technicians. Project Engineer II 03/2017 03/2018 Company Name – City State Working product management, Clinical Analyst, sales, regulatory determine optimal design inputs new products. Completed design transfer attained 510k Class IIb device year. Lead cross functional team including consulting agency order Develop drug device combination product research optimal process using DOE order mass production. Leading aspects design control designing solid works process validations V&V Testing. Analyzing resolving field failures investigation testing. Experienced working international regulatory teams providing information foreign registration. Responsible gap analysis test planning order create meet deadline projects. Experienced reviewing approving validation activities well provide support staff achieve project milestones. Experienced working cross functional teams complete projects tasks. Engineer I 06/2013 03/2017 Company Name – City State Worked bring Drug Device Combination product mass production. Completed new Class IIa product completed project 10 months. Completing CAPAs resolving field failures research testing. Developed new testing methods designed tooling new testing. Experienced using Injection Molding Machine Create Test Prototypes. Found cheaper responsible vendor MRI related testing. Education Bachelor Science Mechanical Engineering 05/2013 Temple University City State Certifications Management Leadership Certification Six Sigma Greenbelt certification Work History Engineering Manager 03/2018 Current City State Create maintain Technical Files per MDR requirements well attaining 510k legacy products. Assess testing gaps legacy products design creep. Experienced working multiple departments. Experienced training leading engineers order investigate field complaints, Gap analysis building Technical files/DHF. Experienced leading team engineers lead aspects design process, including regulatory needs per market development per design control. Tasked create test plan analysis existing Class I, II III products Testing per latest applicable requirements. Trained team conducting project related cost analysis, test gap analysis researching ISO/EN ISO/ASTM requirements. Leading companywide EU MDR product transfer testing Infusion products, Dialysis products standalone products. Provided technical direction MDR 510k related projects initiatives engineers technicians. Project Engineer II 03/2017 03/2018 Company Name – City State Working product management, Clinical Analyst, sales, regulatory determine optimal design inputs new products. Completed design transfer attained 510k Class IIb device year. Lead cross functional team including consulting agency order Develop drug device combination product research optimal process using DOE order mass production. Leading aspects design control designing solid works process validations V&V Testing. Analyzing resolving field failures investigation testing. Experienced working international regulatory teams providing information foreign registration. Responsible gap analysis test planning order create meet deadline projects. Experienced reviewing approving validation activities well provide support staff achieve project milestones. Experienced working cross functional teams complete projects tasks. Engineer I 06/2013 03/2017 Company Name – City State Worked bring Drug Device Combination product mass production. Completed new Class IIa product completed project 10 months. Completing CAPAs resolving field failures research testing. Developed new testing methods designed tooling new testing. Experienced using Injection Molding Machine Create Test Prototypes. Found cheaper responsible vendor MRI related testing. Skills Microsoft Office Microsoft Project Product development Quality Research Six Sigma Green Belt Solid Works Visio Prioritization Personnel management Critical thinking skills Team management, Analyst, agency, consulting, cost analysis, Critical thinking, Designing, Dialysis, direction, Develop drug, functional, IIa, ISO, Leadership, market development, Microsoft Office, Microsoft Project, Personnel management, design process, Product development, product management, Quality, researching, Research, sales, Six Sigma, Solid Works, Team management, validation, Visio