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Senior Manufacturing Engineer
Senior Manufacturing EngineerSYNCARDIA SYSTEMS ACQUISITION LLC • Tucson, AZ, US
Senior Manufacturing Engineer

Senior Manufacturing Engineer

SYNCARDIA SYSTEMS ACQUISITION LLC • Tucson, AZ, US
2 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Description :

Essential 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 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.

Requirements :

Skills and Abilities (Required for the Job)

  • 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
  • Education, Experience, and Training (Required for the Job)

  • Bachelor's Degree or Master's Degree in Mechanical Engineering or Biomedical Engineering
  • General understanding of mechanical design philosophies, process, tools and standards
  • Regulated device experience
  • Working Environment

  • Work Station Area : Office
  • Special Factors in the Work Area :

  • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
  • Prolonged periods of sitting, keyboarding / working on a computer, and the ability to move objects weighing up to 30 pounds.
  • The position requires the ability to communicate in person, telephonically and via email.
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    Senior Manufacturing Engineer • Tucson, AZ, US