Senior Mechanical Engineer

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 achieved

C. 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 objectives

III. 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.

IV. Position Requirements

A. Skills and abilities (required for the job)

• SolidWorks CAD software (v2012 or later), including
• 3D modeling, for component & assembly
• Detailed dimensioned drawings, for components & assemblies
• Bills of materials
• Knowledge of pneumatic systems
• Basic knowledge of mechanical measurements tools and techniques
• Plastic and metal part and assembly design and documentation
• Experience with geometric dimensioning and tolerancing per ASME Y14.5M
• Physical requirements analysis
• Mechanical concepts and design
• Presenting technical information
• Quality focus
• Excellent communication skills
• Excellent writing skills
• Strong organizational skills
• Detail oriented
• Ability to handle multiple tasks simultaneously
• A team player / collaborative
• Professional ethics
• Ability to react and learn quickly in a dynamic environment

B. 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 experience
• MS in Mechanical or Electrical or related engineering highly preferred
• A documented history of demonstrating exception performance within SynCardia may reduce experience requirements
• General understanding of mechanical design philosophies, process, tools and standards
• Regulated device experience

C. 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.