PRINCIPAL RESPONSIBLITIESPrincipal responsibilities for the position include the following. Other duties may be assigned as necessary.
- Design Custom Orthopedic Implants
- Analyze CT scan data and translate into 3D models
- Produce surgical simulations (resections, alignments, etc.)
- Design implants based on surgeon input and measurements with quick turnaround times
- Design implant trials, cutting guides, or other instrumentation needed for implant placement
- Draft Project Documentation
- Produce surgical guides with anatomy, implant variations, cutting guides, and trials
- Determine inspection criteria and mechanical strength analysis
- Produce accurate quality documentation relevant for each case
- 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)
- Clinical Representative
- Attend orthopedic cases and verbally assist in surgical process and custom device related surgical steps
EDUCATION- Bachelor of Science in an engineering or equivalent discipline (mechanical, biomedical, etc.)
PREFERED EXPERIENCE- Extensive experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, etc.)
- Independent worker willing to learn and develop necessary design, manufacturing, and software skills though guided training
- Self-starter willing to take ownership of assigned cases
- Ability to work flexible hours if needed
ADDITIONAL QUALIFICATIONS- Understanding of human anatomy (through coursework or training)
- 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
