Senior Manufacturing Process Engineer

8 hours ago


Reston, Virginia, United States Meet Full time

Senior Manufacturing Engineer (Onsite)

Meet is seeking a highly skilled Senior Manufacturing Engineer to join their team in San Diego county. As a key member of the process development and manufacturing engineering department, you will play a critical role in the development of breakthrough technology and innovative devices to treat cardiovascular diseases.

Key Responsibilities:

  • Develop and implement new manufacturing processes for new and current medical devices, ensuring quality and efficiency.
  • Collaborate with suppliers worldwide to understand and define their manufacturing processes, equipment, and tools/fixtures.
  • Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing.
  • Create and maintain manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
  • Lead a team of engineers and technicians on business activities for manufacturing, driving innovation and process improvement.

Requirements:

  • Bachelor's Degree in Engineering (Mechanical, Electrical, or similar)
  • Minimum of 5 years experience as a process/manufacturing engineer in the medical device industry, 8+ years of experience preferred.
  • 3 years minimum of previous catheter process development and manufacturing experience is required.
  • Experience in Design for Manufacturing, Assembly, and Test (DFMAT), Six Sigma, Lean Manufacturing & Design of Experiments (DoE).
  • Experience creating technical manufacturing documentation.
  • Understanding of medical device Quality Management Systems, design controls, and product development processes.
  • SolidWorks/CAD software experience.


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