Mechanical Engineer III

2 weeks ago

Andover, United States TransMedics, Inc. Full time

Job Title: Mechanical Engineer III - Product Development

Reports to: Director of Mechanical Engineering

TransMedics Inc. was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs. Our Vision is that the Organ Care System will become the new standard of care for organ preservation worldwide. The department of Manufacturing Engineering focuses on manufacturing of the Organ Care System at our headquarters in Andover Massachusetts. The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients’ lives.

ESSENTIAL TASK AND DUTIES INCLUDE:

  • Lead the development of next generation disposables, durables, and accessories for the OCS Heart, OCS Lung and OCS Liver product lines.
  • Responsible for CAD design, building, and testing of new concepts and iterating through the design process.
  • Provide direction technicians, external industrial design teams, and OEM manufacturers.
  • Work closely with manufacturing engineering and apply DFM techniques to ensure product is capable of being assembled and tested using automation.
  • Perform thorough analysis (tolerance, dFMEA, DOE, statistical) to ensure product will meet design requirements.
  • Manage injection mold suppliers through the tool development process and ensure conformance to specifications.
  • Develop drawings and release documentation in accordance with applicable standards and SOPs.
  • Assist V&V testing with protocols, reports, fixtures, and TMVs.
  • Maintain DHF including design reviews, reports, meeting minutes, etc.
  • Perform other development tasks and duties as required.

BACKGROUND AND QUALIFICATIONS:

  • 5+ years of product development experience as mechanical design engineer for complex Class II or III disposable and/or electromechanical medical equipment.
  • Competent in Solidworks 3D modeling and design. 3D surfacing expertise desired.
  • Experienced in design of injection molded disposables and plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.
  • Some experience in design of electromechanical sub-systems including machined/sheet metal components and motorized assemblies desired.
  • Solid foundation of mechanical engineering fundamentals and ability to perform engineering analysis including tolerance analysis, GD&T, FEA, engineering 1st principles.
  • Ability to work independently with guidance.
  • Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
  • Hands-on skills and ability to use power tools and light machine shop equipment required.
  • Strong written and verbal communication skills are required.
  • Understanding of medical device development processes including experience with FDA CFR 820, ISO 13485, IEC 60601-1 regulations and standards.
  • Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
  • Some project management experience & Six Sigma Green Belt desired.
  • Ability to be onsite 5 days per week and lift 25lbs.
  • 5% Domestic or International travel may be required.

EDUCATION:

  • BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required.

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