NPI Manufacturing Engineer

5 days ago


Andover, United States TransMedics, Inc. Full time

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
  • Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
  • Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being 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.
  • Develop Critical to Assembly (CTA) requirements as required for manufacturing processes.
  • Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques.
  • Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing.
  • Collaborate and communicate with cross-functional teams and leadership.
  • Perform other TransMedics tasks and duties as required.


BACKGROUND AND QUALIFICATIONS:

  • 5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
  • Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
  • Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
  • Demonstrated expertise in automated assembly methods, robotics, PLCs, automated inspection, and fixture design.
  • 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. Experience using Minitab or similar statistical evaluation software/tools preferred.
  • Effective analytical and decision-making skills.
  • Detail oriented with strong organizational skills.
  • Able to work collaboratively in a cross-functional team environment.
  • Excellent verbal and written communication skills.


EDUCATION:

  • BS in Mechanical Engineering or other engineering discipline is required.


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