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:- Develop and maintain strong internal working relationships across restor3d.
- Understand the objectives, responsibilities, and mission of the Digital Production department and work towards those goals.
- Prioritize and plan work activities; adapt for changing conditions.
- Design Patient Specific 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
- Lead call prep and design activities on complex and new case types
- Set design acceptance criteria for each case type within focus area
- 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
- 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)
- Lead efforts to improve first pass manufacturing yield of complex designs
- Clinical Representative
- Attend orthopedic cases and verbally assist in surgical process and patient specific device related surgical steps
- Managerial Responsibilities
- Lead team of engineers responsible for design of designated case types
- Liaison with commercial team to gather relevant case information and assign cases to engineers
- Assist in scheduling of cases with inputs from the commercial and operations teams
- Responsible for training of team members to designated case types
- Delivery of designs and documentation on-time per approved processes
- Reduce digital production COGS of designated cases by driving efficiency improvements
- Reinforce a quality-centric attitude to the team
- Other responsibilities as assigned.
Qualifications:- Bachelor of Science in an engineering or equivalent discipline (Biomedical or Mechanical Engineering preferred)
- Extensive experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, Blender, etc.)
- Independent worker looking to learn and develop new designs and efficiency improvements
- Self-starter willing to take ownership of designated case types
- Willingness to work a flexible schedule to accommodate design call and case volumes
- Leadership experience
- 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
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.
restor3d is an Equal Opportunity Employer