Manufacturing Engineer III

3 days ago

Andover, Massachusetts, United States TransMedics Full time
Job Description:

TransMedics is seeking a highly skilled Manufacturing Engineer III to join our team. As a key member of our NPI Manufacturing team, you will be responsible for contributing to the development of new products and processes, ensuring production capacity, efficiency, and quality standards are met.

Key Responsibilities:
  • Contribute to NPI manufacturing activities associated with the development of new products and processes.
  • Coordinate and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are met.
  • Generate and validate work instructions and test procedures.
  • Specify, design, and install equipment, tooling, and fixtures used in production.
  • Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
  • Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
  • Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
  • Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing.
Requirements:
  • 5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
  • Prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
  • Demonstrated experience in the selection and qualification of assembly equipment and automation.
  • Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
  • Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
  • Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
Education:
  • BS in Mechanical Engineering or other engineering discipline is required.

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, or protected veteran status, or any other characteristic protected by law.

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