Sr. Product Development Engineer

4 days ago


Knoxville, United States CivicMinds, Inc Full time

Seeking a highly skilled Mechanical or Biomedical Engineer with 5+ years of product development experience to design and enhance spinal implants and instruments. Responsible for leading complete product development processes, including concept design, testing, and verification/validation. Must have proficiency in CAD software, knowledge of manufacturing processes, and familiarity with relevant standards and regulations. Excellent communication skills and ability to work in a fast-paced environment are essential. Experience in Spinal or Orthopaedic Implant design is preferred.

Responsibilities:

  • Research, develop, and design spinal implants & instruments in compliance with FDA and ISO requirements.
  • Lead complete product development process from concept to launch.
  • Create designs using CAD (SolidWorks) for both subtractive and additive manufacturing methods.
  • Write protocols, execute tests, and analyze data to verify designs meet specifications.
  • Manage 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.
Physical Demands:
  • Regularly required to sit and talk or hear. Occasionally required to stand, walk, use hands, and reach with hands and arms.
  • May need to lift and/or move up to 25 pounds.
Work Environment:
  • Typical office environment with moderate noise levels. Reasonable accommodations may be made for individuals with disabilities.


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