Roles & Responsibilities Lead initiatives focused on yield improvement, material cost reduction, capacity enhancement, and outsourcing of assemblies. Evaluate and challenge mechanism designs for process reliability, serviceability and manufacturability. Provide suggested change proposals. Creating budget estimates for tooling, test equipment, prototype designs, and first article activities. Ensure the processes meet the specified requirements for operation including adherence to parameters, specifications avoiding variations in the manufacturing process. Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns. Qualify, document and introduce production processes. Take responsibility for developing and maintaining compliance with the quality system. Evaluate and select suppliers for mechanical parts. Help resolve supplier quality issues. Must possess strong communication skills to interface with suppliers, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations. Performs other duties as required. Travel: Position may require 5-10% travel, primarily within U.S. Drive our Culture Strategy by fostering our mission, founding principles, individual and leadership expectation Skills, Experience, Education, & Training Required Candidate must be of high character and energy with regard for detail. Demonstrated Mechanical and/or Process Engineering ability. Demonstrated ability in failure analysis and continuous improvement. BS degree in Mechanical Engineering or equivalent. Minimum 3 years manufacturing engineering management experience with mid/high volume complex manufacturing processes. Preferred MS degree in an Engineering discipline. 3 to 5 years of experience as design or manufacturing engineer supporting product with significant mechanical/process content. Prior experience with various mechanical and or electronics applications and technologies, including reliability and performance assessment. Prior experience working in FDA 21 CFR820/ISO 13485 medical device manufacturing environment. Demonstrate ability to design/execute experiments. Prior responsibility for process or product validation/verification. Experience with ASME Y14.5 Geometric Dimensioning and Tolerance. Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques. #J-18808-Ljbffr