Job Description
Job Description
Description :
I. General Information
Exempt / Nonexempt : Exempt
II. Essential Duties and Responsibilities
A. Department Specific 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 mechanical engineering and project leadership to support research and development activities.
- 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.
B. Position Specific Duties and Responsibilities
Evaluates mechanical, electromechanical and pneumatic systems and products by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.Assist in the sustaining engineering and improvement of existing Total Artificial Heart System products.Assist in the research and development of new products to support the Total Artificial Heart System.Confirm system and product capabilities by designing feasibility and testing methods.Assist and provide ownership to create and revise product requirement specifications.Assist and provide ownership to develop and improve manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.Prepare product test and investigation reports by collecting, analyzing, and summarizing information.Maintain system and product drawing data base.Contribute to engineering or company team assignments.Research and champion an understanding of regulatory requirements as related to mechanical engineering for SynCardia products.Actively participate in new product transfer into manufacturing and ensure engineering and quality documentation requirements are achievedC. Role Specific Duties and Responsibilities
Provide mechanical engineering support for existing Total Artificial Heart System products in manufacturing and research and development activities, and assist with design and analysis to ensure product changes and improvements are conducted within performance, schedule and cost objectivesIII. 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.Requirements :
IV. Position Requirements
A. Skills and abilities (required for the job)
SolidWorks CAD software (v2012 or later), including3D modeling, for component & assemblyDetailed dimensioned drawings, for components & assembliesBills of materialsKnowledge of pneumatic systemsBasic knowledge of mechanical measurements tools and techniquesPlastic and metal part and assembly design and documentationExperience with geometric dimensioning and tolerancing per ASME Y14.5MPhysical requirements analysisMechanical concepts and designPresenting technical informationQuality focusExcellent communication skillsExcellent writing skillsStrong organizational skillsDetail orientedAbility to handle multiple tasks simultaneouslyA team player / collaborativeProfessional ethicsAbility to react and learn quickly in a dynamic environmentB. Education, experience and training (required for the job)
Bachelor’s Degree in Mechanical Engineering and 10-15 years of similar industry experience, or Master’s Degree in Engineering and 5-10 years of similar industry experienceMS in Mechanical or Electrical or related engineering highly preferredA documented history of demonstrating exception performance within SynCardia may reduce experience requirementsGeneral understanding of mechanical design philosophies, process, tools and standardsRegulated device experienceC. Working environment
Work Station Area : OfficeSpecial Factors in the Work Area : NoneThe 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.