Senior Manufacturing Engineer Job at SYNCARDIA SYSTEMS, LLC. in Tucson

Job Description Job Description Description: Essential Duties and Responsibilities Provide mechanical engineering and project leadership to support existing Total Artificial Heart System productions in Sustaining Engineering and manufacturing as required by business needs. Provide engineering information by answering questions and requests. Maintain product and company reputation by complying with government regulations. Maintain good documentation practices for all aspects of work. Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Develop and manage budgets, timelines, and resources for manufacturing projects. Train and mentor team members to promote professional growth and development. Develop and execute plans to ramp up production capacity in response to increased demand or new product introductions Manage the transfer of production processes and equipment from development to manufacturing, ensuring all requirements are met and risks are mitigated. Develop and validate tooling designs which meet the requirements of the manufacturing process, including precision, repeatability, and ease of use. Use value stream mapping to visualize and analyze the flow of materials and information through the production system, and identify opportunities for improvement. Identify and eliminate waste in the manufacturing process, including defects, overproduction, waiting time, excess inventory, unnecessary motion, and unused talent. Confirm system and product capabilities by designing feasibility and testing methods. Assist to create and revise product requirement specifications. Prepare product test and investigation reports by collecting, analyzing, and summarizing information. Research and champion an understanding of regulatory requirements as related to mechanical engineering for SynCardia products. Requirements: Skills and Abilities (Required for the Job) SolidWorks CAD software or equivalent 3D modeling software and tool design Demonstrated experience in applying Lean Six Sigma methodologies to improve manufacturing processes and drive continuous improvement initiatives. Experience leading manufacturing projects Detailed dimensioned drawings, for components & assemblies Knowledge of pneumatic systems Basic knowledge of mechanical measurements tools and techniques Experience with geometric dimensioning and tolerancing per ASME Y14.5M Excellent communication skills Excellent technical writing skills Strong organizational skills Detail oriented Ability to handle multiple tasks simultaneously A team player / collaborative Ability to react and learn quickly in a dynamic environment Education, Experience, and Training (Required for the Job) Bachelor's Degree or Master's Degree in Mechanical Engineering or Biomedical Engineering General understanding of mechanical design philosophies, process, tools and standards Regulated device experience Working Environment Work Station Area: Office Special Factors in the Work Area: The working environment is indoors and is seasonally heated and cooled with minimal noise levels. Prolonged periods of sitting, keyboarding/working on a computer, and the ability to move objects weighing up to 30 pounds. The position requires the ability to communicate in person, telephonically and via email.6b250ea6-cee3-481d-915c-f7283f1b2f1b