Senior Manufacturing Engineer - SynCardia Systems, LLC
Tucson, AZ
Full Time
Experienced
Company Description:
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and sell the world's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart as bridge to transplant for patients suffering from biventricular heart failure The SynCardia Total Artificial Heart™ is available in two sizes to accommodate patients’ diverse physiologies. The Freedom Portable Driver™ allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant. The SynCardia Total Artificial Heart™ has been successfully used in over 2,000 patients and is the most widely used and extensively studied total artificial heart in the world. For additional information and label information, visit us at www.syncardia.com.
Position Description:
SynCardia Systems, LLC is seeking a Mechanical Engineer to support the production and manufacturing of our Total Artificial Heart System. This role focuses on sustaining engineering efforts, ensuring compliance with regulatory standards, and driving continuous process improvements.
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.
- Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
- Identify and record potential problems relating to the product, process and Quality System.
- Initiate, recommend or provide solutions through designated channels.
- Record and/or report all instances of customer feedback on product.
- 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
- Bachelor's Degree or Master's Degree, or 5 years of relevant experience in Mechanical Engineering or Biomedical Engineering
- General understanding of mechanical design philosophies, process, tools and standards
- Regulated device experience
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