Product Development Engineer

3 days ago


Knoxville, Tennessee, United States CivicMinds, Inc Full time
Job Title: Sr. Product Development Engineer

CivicMinds, Inc is seeking a highly skilled Sr. Product Development Engineer to lead the design and development of spinal implants and instruments. The ideal candidate will have a strong background in mechanical or biomedical engineering and experience in product development.

Responsibilities:
  • Develop and design spinal implants and instruments in compliance with FDA and ISO requirements.
  • Lead the complete product development process from concept to launch.
  • Create designs using CAD software for both subtractive and additive manufacturing methods.
  • Write and execute test protocols to verify designs meet specifications.
  • Manage the Change Order process for device-related changes and Quality Management System documents.
  • Interface with customers, suppliers, and internal teams to ensure project milestones are met.
  • Conduct stress analysis on designs using FEA and interpret results.
  • Assist in the patent submission process.
Qualifications:
  • BS in Mechanical Engineering or Biomedical Engineering.
  • 5+ years of product development experience, preferably in Spinal or Orthopaedic Implant design.
  • Proficiency in CAD software (SolidWorks preferred).
  • Knowledge of manufacturing processes and materials for medical implants.
  • Experience with GD&T, mechanical testing, and relevant standards and regulations.
  • Strong communication skills and ability to manage multiple tasks in a fast-paced environment.
Work Environment:
  • Typical office environment with moderate noise levels.
  • Reasonable accommodations may be made for individuals with disabilities.


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