Manufacturing Process Engineer

8 hours ago


Reston, Virginia, United States Meet Full time

Meet Our Team: Senior Manufacturing Engineer

A leading medical device company is seeking a highly skilled Senior Manufacturing Engineer to join their team. As a key member of the manufacturing engineering department, you will play a critical role in leading and executing manufacturing projects to support new product introduction, process development and optimization, and manufacturing scale-up efforts.


Key Responsibilities:

  • Develop and implement new manufacturing processes for new and current medical devices, ensuring compliance with regulatory requirements.
  • Collaborate with global suppliers to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are being delivered.
  • Conduct characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • 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, providing guidance and support as needed.
  • Drive innovation, design, and development of processes, procedures, tooling, and automation to improve manufacturing efficiency and productivity.

Requirements:

  • Bachelor's Degree in Engineering (Mechanical, Electrical, or similar)
  • Minimum of 4 years experience as a process/manufacturing engineer in the medical device industry, 6-7 years of experience preferred.
  • Proven experience in electromechanical/electronics medical device manufacturing, with knowledge of IEC 60601-x and ISO 13485.
  • CNC manufacturing experience and proficiency in FMEA, root cause analysis, and GD&T.
  • Excellent technical writing skills, with experience creating technical manufacturing documentation.
  • Strong understanding of medical device Quality Management Systems, design controls, and product development processes.
  • Proficiency in SolidWorks/CAD software.


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