Patient Specific Design Engineer

• 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.

• 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

• 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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