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Senior Manufacturing Process Engineer

1 month ago

Reston, Virginia, United States Meet Full time

Meet Our Team: Senior Manufacturing Process Engineer

A leading medical device company in San Diego county is seeking a Senior Manufacturing Process Engineer to join their process development and manufacturing engineering department. The company is pioneering breakthrough technology and innovative devices to treat cardiovascular diseases. The Manufacturing department is expanding to prepare for the upcoming launch and commercialization of new device products in the US and Europe.

Key Responsibilities:

  • Develop and implement new manufacturing processes for new and current medical devices.
  • Collaborate with suppliers worldwide to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are delivered.
  • Conduct characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Create 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.
  • 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 of 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.