Senior Development Engineer with over 9 years of design experience for the medical device industry. Mechanical part design expertise in machined, sheet metal, and molded components (Injection, Reaction Injection [RIM], and Over Molding). Strong research skills and knowledge in many troubleshooting methodology's needed throughout the design process including: structured DOE designs, Root Cause Analysis and Corrective Actions (RCCA), Five Why Method, etc. Extensive knowledge in Design Controls and Quality Systems within a regulated environment, with experience in Design Verification and Validation, Component Qualification, Equipment IQ/PQ/OQ, and statistical analysis. Experience with SAP Windchill and Agile PLM Systems. Key attributes include leadership, project management, research, and mechanical-design skills. Strong commitment to collaborating with cross-functional colleagues in order produce quality work in an efficient timeframe. Experience in leading a team of several development engineers with a track-record of successfully meeting project commitments. Skillsets:Designing and managing large BOMs for complex electromechanical productsStrong understanding of different manufacturing methods and their capabilitiesASME Y14.5 Dimensioning and Tolerancing with experience in GD&T Tolerance Stack AnalysesStrong CAD Designer with extensive experience in Solidworks and Solidworks PDM ManagementProject Management skills including schedule generation in Microsoft Project, Sprint Planning, etc.Experience with IEC 60601, ISTA, and other Standard Compliance TestingProduct Requirement Creation, Management, and Testing (Design Input/Design Output) ExperienceFailure Mode & Effects Analysis / Risk Management Experience including DFMEA and PFMEATrained in Design of Service and DFX PrincipalsNew Product Development (NPD) and Change Management for Released Product Experience within Agile and SAP Windchill PLM Systems