Responsible for leading the design and development of innovative new products. Identify opportunities and develop new concepts with emphasis on manufacturability, customer satisfaction, project timeframes, and potential profitability of designs. Regularly review project plans, schedules, progress, expenditures and priorities to ensure goals are being met. Interface with marketing and manufacturing.

•Create and review component and assembly drawings of surgical instruments.•Specify materials, heat treatments, and finishes to be used for instruments.•Perform tolerance analysis and specify manufacturing tolerances.•Familiar with GD&T (Geometric Dimensioning and Tolerancing) and associated gauging.•Perform FEA (Finite Element Analysis) for new products as required.•Provide training and technical support for designers and new engineers.•Project Lead and/or Engineer responsible for creation of Design History files of new and existing products including design and process FMEA’s (Failure Mode and Effects Analysis) activities.•Specify, perform, and review verification and validation testing including failure analysis.•Provide engineering support for all company products at all phases of manufacturing.•Assist Quality department in failure analysis of customer returns.•Part of team that documented Product Development procedures to meet ISO 13485 Design Controls.•Perform work related to bills of materials and engineering change orders.

Startup company. Designed and development company standard line of surgical instruments. Created procedures and forms for Product Design Cycle compliant with ISO 13485. Assisted Sales with technical questions. Performed testing of company products.

Performed design work related to customizing standard products to meet customer requirements for surgical instruments. Specified, oversaw, and reviewed testing of surgical instruments. Reviewed and reported on customer returns for failure analysis. Day-to-day engineering: engineering change orders, checked others drawings and bills of materials, assisted customers, sales, and customer service with technical questions.