Sustaining Engineer

General Information
  • Date Job Description Completed: April 2021
  • Reports to: Production Manager or Failure Investigation Manager and Sr. Mechanical Engineer
  • Supervises: N/A
  • Exempt/Nonexempt: Exempt 

Essential Duties and Responsibilities

  • Department Specific Duties and Responsibilities
    • Provide engineering and project support for existing Total Artificial Heart System products in sustaining engineering and manufacturing as required by business needs.  
    • Provide support and perform analysis to help ensure aspects of sustaining projects are completed within performance, schedule and cost objectives.
    • Actively participate in transfer of new products/design changes into manufacturing while ensuring that quality documentation requirements are achieved.
    • Participate, as directed, in related quality projects to gain a solid working understanding of SynCardia business and quality systems.
    • Maintain good documentation practices for all aspects of work, especially with regard to experimental work.
    • Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. 
  • Position Specific Duties and Responsibilities
    • Support project planning and execution of planned activities relating to sustaining projects, manufacturing transfers, and existing product design changes, or obsolescence.
    • Support Failure investigations (FI’s) for customer experiences and nonconformance reports, performing root cause analysis with full supporting documentation maintained throughout. 
    • Leverage understanding of engineering, biology, physiology, and clinical issues to provide user/clinical input in multi-disciplinary meetings/projects.
  • Role Specific Duties and Responsibilities
    • Actively participate in and support current products within the Total Artificial Heart product line using a creative, user-inspired approach. 
    • Provide support in coordinating verification and validation testing activities and risk management activities while working closely with engineering, quality, regulatory and clinical support to ensure revenue and customer satisfaction goals are met. 
    • Create and revise requirement and component specifications in accordance with established design and document control procedures.
    • Develop manufacturing test processes by designing and modifying equipment for product verification and final acceptance testing with full supporting documentation maintained throughout.
    • Provide engineering information by answering questions and requests in a complete and concise manner and author supporting documentation as applicable. 
    • Actively participate in product transfer into manufacturing and ensure engineering and quality documentation requirements are achieved.
    • Research and champion an understanding of regulatory requirements as related to sustaining engineering for SynCardia products.
    • Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems.
Responsibility and Authority Affecting Quality
  • 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.
  • Participate in nonconformance reporting of TAH-t System products and verify the implementation of solutions.
  • Actively participate in corrective and preventative action meetings and assignments to address top quality priorities.
Position Requirements
  • Skills and abilities (required for the job)
    • Demonstrate continual improvement in all areas of work, especially where a need has been identified. Show active efforts to improve where needed and prevent recurrence of issues requiring correction through proper planning, execution and iteration until resolution is complete.
    • Present technical information.
    • Quality focus.
    • Excellent documentation practices.
    • Excellent communication and presentation skills.
    • Excellent writing skills.
    • Strong organizational skills.
    • Detail-oriented.
    • Ability to handle multiple tasks simultaneously and learn quickly in a dynamic environment.
    • Understanding of root cause failure investigation methods.
    • A team player with strong professional ethics.
    • Experience with product validation, failure modes effects analysis and test system architecture.
    • Able to develop diagnostic methods and tools required to improve troubleshooting and repair.
    • Experience with remote programming control of test equipment and development of test fixtures is a plus.
  • Education, experience and training (required for the job)
    • Bachelors of Science in an Engineering field. 
    • Experience in an engineering or medical device manufacturing environment preferred.
    • Ability to react and learn quickly in a dynamic environment.
    • General understanding of design philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems and professional ethics.
  • Working environment
    • Work Station Area: Office
    • Special Factors in the Work Area:  None
      • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.  
      • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.  
      • The position requires the ability to communicate in person, telephonically and via email.
Apply Today

Interested in applying for this position? Please send your cover letter and resume to humanresources@syncardia.com.