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Patient Specific Design Engineer

Patient Specific Design Engineer

restor3dDurham, NC, US
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Job Description

Job Description

Job Summary

The Patient Specific Design Engineer will be responsible for collaborating closely with surgeons to create customized implants and instruments for a range of orthopedic uses.

Essential Duties and Responsibilities :

  • Design Patient Specific Orthopedic Implants

Analyze and understand CT scan data and how it translates to 3D models

  • Produce surgical simulations (resections, alignments, etc.)
  • Design patient specific implants based on surgeon input and measurements with quick turnaround times
  • Design implant trials, cutting guides, or other instrumentation needed for implant placement
  • Contribute to efforts to improve team efficiency and case throughput
  • Draft Project Documentation

    • Produce case specific surgical technique guides

  • Determine inspection criteria and perform mechanical strength analyses for designated cases
  • Produce accurate quality documentation relevant for designated case types
  • Contribute to efforts to improve quality in all processes and reduce non conformances
  • Design for Manufacturing

    • Work closely with operations to ensure manufacturability of design work

  • Modify designs for printability based on the type of printer to be used (FDM, SLA, DLP, SLS)
  • Contribute to efforts to improve first pass manufacturing yield of complex designs
  • Clinical Representative

    • Lead virtual design calls with surgeons to gather design inputs.

  • Attend orthopedic cases and verbally assist in surgical process and patient specific device related surgical steps
  • Other responsibilities as assigned.

    • Qualifications :

  • Bachelor of Science in an engineering or equivalent discipline (Biomedical or Mechanical Engineering preferred)
  • Experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, Blender, etc.)
  • Willingness to work a flexible schedule to accommodate design call and case volumes
  • Understanding of human anatomy (through coursework or training)
  • Independent worker looking to learn and develop new designs and efficiency improvements
  • Experience with design and manufacturing of medical implants (ISO 13485 and FDA 21 CFR 820)
  • Experience working under a quality management system for medical devices or other regulated design fields
  • Orthopedic implant design and development experience
  • Experience with custom order engineering
  • Experience with 3D printing

    • Skills, Abilities, Competencies Required :

  • Excellent written and verbal communication skills.
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
  • Strong organizational, analytical, and time-management skills.
  • Able to self-motivate and work both independently and as part of a team.
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    Design Engineer • Durham, NC, US