Job Summary:

The Sr. Patient Specific Design Engineer is responsible for leading a team of engineers to design patient-specific orthopedic implants by analyzing CT scan data, producing 3D models and surgical simulations, ensuring manufacturability, drafting detailed documentation, and maintaining high quality and efficiency standards.

Essential Duties and Responsibilities:

• Develop and maintain strong internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Patient Specific 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.)
• 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.
• 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

restor3d is an Equal Opportunity Employer