Senior Manufacturing Engineer

Position Overview

This role is pivotal in providing mechanical engineering and project leadership to support the production of the Total Artificial Heart System. The candidate will drive process improvements through Lean Six Sigma methodologies, ensure compliance with government regulations, and contribute to the overall success of SynCardia’s manufacturing operations.

Key Responsibilities

• Provide mechanical engineering and project leadership to support existing production in Sustaining Engineering and manufacturing as required.
• Answer engineering questions and requests to provide critical information.
• Maintain product and company reputation by adhering to government regulations.
• Maintain meticulous documentation practices for all aspects of work.
• Participate in projects to gain a deep understanding of SynCardia’s business and quality systems.
• Enhance professional knowledge through workshops, publications, networking, and professional societies.
• Develop and manage budgets, timelines, and resources for manufacturing projects.
• Train and mentor team members to foster professional growth.
• Develop and execute plans to ramp up production capacity in response to demand or product introductions.
• Manage the transfer of production processes and equipment from development to manufacturing, ensuring requirements are met and risks mitigated.
• Develop and validate tooling designs that meet manufacturing requirements including precision and repeatability.
• Utilize value stream mapping to visualize and improve the flow of materials and information through the production system.
• Identify and eliminate wastes such as defects, overproduction, waiting time, excess inventory, unnecessary motion, and unused talent.
• Confirm system and product capabilities by designing feasibility studies and testing methods.
• Assist in creating and revising product requirement specifications.
• Prepare product test and investigation reports by collecting, analyzing, and summarizing data.
• Research and promote understanding of regulatory requirements related to mechanical engineering for SynCardia products.

Required Qualifications

• Proficiency with SolidWorks CAD software or equivalent 3D modeling software and tool design.
• Demonstrated experience applying Lean Six Sigma methodologies to improve manufacturing processes and drive continuous improvement initiatives.
• Experience leading manufacturing projects.
• Ability to produce detailed dimensioned drawings for components and assemblies.
• Knowledge of pneumatic systems and mechanical measurement tools and techniques.
• Experience with geometric dimensioning and tolerancing per ASME Y14.5M.
• Excellent communication and technical writing skills.
• Strong organizational skills with attention to detail and the ability to manage multiple tasks simultaneously.
• A collaborative team player who reacts and learns quickly in a dynamic environment.
• Bachelor's or Master's Degree in Mechanical Engineering or Biomedical Engineering.
• Understanding of mechanical design philosophies, processes, tools, and standards.
• Experience with regulated device manufacturing.