Senior Manufacturing Engineer at SYNCARDIA SYSTEMS LLC – Tucson, Arizona

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.

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.