Job Summary Responsible for leading all phases of the product development process in support of immediate, mid-term, and long-term innovation and product design strategies. Provide expertise to guide product divisions to navigate the development of new products and technologies. MAJOR RESPONSIBILITIES: Manage the design control process including investigation of user need and product requirement/specifications, coordinate verification and validation activities, coordinate design transfer activities and multi-source projects, determine performance impacts and process change of new materials and designs, conduct risk assessment activities, and resolve residual risk. Investigate root causes and provide corrective actions on product failures. Work with manufacturers to implement corrective actions. Coordinate with end users and marketing to identify product opportunities and establish a vetted business case. Oversee product development timelines and balance corporate priorities to ensure that deadlines and goals are met. Work with internal or external design teams to generate product designs and technical specifications. Evaluate prototypes for usability, manufacturability, performance, and quality. Work with legal to identify opportunities to protect product designs through patents, trademarks, or other intellectual property techniques. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering or Science. Work Experience At least 2 years of product development experience. PREFERRED JOB REQUIREMENTS Experience in the development and launch of new medical/pharma products. Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process. Experience with project management and Microsoft project. Experience utilizing Minitab to perform analysis of test data. Experience with CAD systems, FEA, Six Sigma, ANDA, ISO/CE Mark, GLP, GMP, GDP, USP testing, and high volume manufacturing processes. Position requires travel up to 10% of the time for business purposes (domestic and international). J-18808-Ljbffr