Senior Manufacturing Engineer

145069
  • 120000 USD - 150000 USD
  • Laguna Hills, United States
  • Permanent

Senior Manufacturing Engineer (Onsite)

A growing medical device company located in Orange county is looking to hire a Senior or Staff Engineer for their manufacturing engineering department. The company is developing breakthrough technology and innovative devices to treat cardiovascular diseases. The Manufacturing Engineering team growing to support launch and production of new products and process improvement and scale-up of existing manufacturing lines. This Manufacturing Engineer will be responsible for the development of new and improved manufacturing processes for catheter based medical devices.

 

Role Responsibilities:

  • Create and implement new manufacturing processes for new and current medical devices.
  • Work with suppliers around the world to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are being delivered.
  • Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Create manufacturing documentation including but not limited to work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
  • Lead team of engineers and technicians on business activities for manufacturing.
  • Innovate, design, and develop processes, procedures, tooling and/or automation.

 

Qualification 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, 5-10 years of experience preferred.
  • Previous catheter process development and manufacturing experience is required.
  • Electromechanical medical device manufacturing experience ideal.
  • Experience in Design for Manufacturing, Assembly, and Test (DFMAT), Lean Manufacturing & Design of Experiments (DoE).
  • Six Sigma and design flow experience
  • Experience creating technical manufacturing documentation such as work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
  • Understanding of medical device Quality Management Systems, design controls, and product development processes.
  • SolidWorks/CAD software experience.
Kristen Tiftickjian Division Manager

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