Senior Manufacturing Engineer

1 month ago


Reston, Virginia, United States Lumicity Full time

As a Senior Manufacturing Engineer at Lumicity, you will play a pivotal role in bridging the gap between Product Development and Manufacturing to create high-quality medical devices. Your expertise will be instrumental in launching new products, reducing costs, and developing innovative manufacturing processes.

Key Responsibilities:

  • Lead the engineering aspects of our Quality Management System, encompassing:
  • Design Controls and Risk Analyses (DFMEA)
  • Design History Files (DHF) and Device Master Records (DMR)
  • Engineering Change Notices and product extensions
  • Ensure compliance of existing products with company and industry standards
  • Conduct design verification and validation activities, including testing protocols and report preparation
  • Oversee the transition to manufacturing, including vendor coordination
  • Collaborate with Clinical and Regulatory Affairs on FDA submissions and inquiries

Requirements:

  • Bachelor's degree in Mechanical Engineering; Master's preferred
  • At least 3 years of experience in engineering or a related field, preferably in medical devices or orthopedics
  • Proven experience in supporting production products, implementing cost-saving measures, and enhancing processes
  • Strong understanding of machining processes, including CNC machining, additive manufacturing, and metal/plastic finishing


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